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CONFLICT OF INTEREST STATEMENT | The authors declare no conflicts of interest. | PMC10770821 | ||
ETHICS STATEMENT | DISEASES | The experiment was performed after an informed consent form was signed by each participant and confirming that none of the students had cardiovascular or other lethal diseases. The study was conducted in accordance with the Declaration of Helsinki and approved by the Bioethics Commission of Hainan Medical University (HYLL‐2021‐369). | PMC10770821 | |
ACKNOWLEDGMENTS | TopEdit | The authors extend their thanks to the 2022 Hainan Province Philosophy and Social Science Planning project and the 2021 Project supported by the education financial support from the Department of Hainan Province. The authors would also like to thank TopEdit ( | PMC10770821 | |
DATA AVAILABILITY STATEMENT | The raw data supporting the conclusions of this article will be made available by the authors upon reasonable request. | PMC10770821 | ||
REFERENCES | PMC10770821 | |||
Background: | ESSENTIAL TREMOR | Transcutaneous afferent patterned stimulation (TAPS) is a wrist-worn, non-invasive therapy delivering calibrated stimulation to the median and radial nerves. Previous randomized controlled studies have demonstrated the efficacy and safety of TAPS therapy in some patients with essential tremor (ET), but evidence supporting therapeutic benefits of TAPS versus standard of care (SOC) is lacking. This randomized prospective study evaluated the clinical benefit of adding TAPS treatment to SOC versus SOC alone. | PMC10588491 | |
Methods: | tremor | SECONDARY | This randomized pragmatic trial recruited patients from a large health plan’s Commercially Insured and Medicare Advantage population. All 310 patients received a TAPS device and were randomized 1:1 to either one month adding TAPS therapy to usual care (TX arm) or usual care with tremor assessment only (SOC arm). The pre-specified endpoints were changes in tremor power measured by motion sensors on the device (primary) and improvement in Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores (secondary) between TX and SOC in all patients who completed the one-month study. | PMC10588491 |
Results: | tremor | SECONDARY | 276 patients completed the one-month study (N = 133 TX, N = 143 SOC). The study met the primary and secondary endpoints, with significantly reduced tremor power in TX compared with SOC (0.017 (0.003) versus 0.08 (0.014) (m/s | PMC10588491 |
Discussion: | tremor | This trial demonstrates that adding TAPS treatment to SOC significantly improves tremor power and BF-ADLs in patients with ET compared to SOC alone over one month of home use. | PMC10588491 | |
Highlights | tremor | This study found that adding TAPS treatment to SOC significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC alone over one month of home use. This real-world evidence study suggests that non-invasive TAPS therapy is a safe and valuable treatment option for patients with ET. | PMC10588491 | |
Introduction | Parkinson’s disease, tremors | ESSENTIAL TREMOR | Patients living with postural and kinetic hand tremors struggle with key activities of daily living such as eating, drinking, and writing [Pharmacological treatments are the primary therapy option for management of ET; however, they are often either ineffective, contraindicated, or associated with side effects that lead to discontinuation for most patients [Given the challenge faced by ET patients and the limited effectiveness and high burden/risk of current treatment options, there is an increasing demand for novel, non-invasive, non-pharmaceutical therapy alternatives. Transcutaneous afferent patterned stimulation (TAPS) is a wrist-worn, non-invasive neuromodulation therapy that delivers individually calibrated stimulation to reduce postural and kinetic tremors. TAPS devices were authorized by the U.S. Food and Drug Administration (DEN170028) for the treatment of essential tremor symptoms, recent label expansion includes both ET and postural and kinetic hand tremors in Parkinson’s disease [While previous studies have demonstrated the effectiveness and safety of TAPS in open-label and sham-controlled studies [ | PMC10588491 |
Methods | PMC10588491 | |||
Study Design | This randomized pragmatic trial recruited patients from the database of a large health insurer (Aetna/CVS Health). All enrolled patients were initially prescribed a TAPS device and then randomized to treatment (TX) or standard of care (SOC) for one month of home use. Patients in the TX arm added TAPS to their physician-recommended care plan while patients in the SOC arm continued with their physician-recommended care plan. After completing one month of SOC, patients in the SOC arm crossed over into TX, and all patients continued with treatment for an additional 11 months of an ongoing open-label 12-month study phase (Figure S1).The study was approved by the Sterling institutional review board (Atlanta, GA, USA) prior to implementation of study procedures, and registered with | PMC10588491 | ||
Patient Randomization | Participants receiving a physician prescription were randomized 1:1 to the TX or SOC arm following a randomization list generated by a study statistician. Randomization was stratified by insurance type (commercial health insurance or Medicare Advantage plan) to ensure a balanced distribution of ages between the TX and SOC arms. | PMC10588491 | ||
Patient Enrollment and Training | tremor, comorbidity | Patients in both arms scheduled an appointment with patient support personnel at Cala Health to complete enrollment and training on proper use of the device (Cala Trio™, Cala Health, San Mateo, CA, USA). All patients received a standard TAPS delivery containing three components sent directly to their home: (1) a wrist-worn stimulator that delivers an individualized stimulation pattern to the median and radial nerves, and measures patients’ tremor during postural holds with an on-board accelerometer, (2) a detachable wristband with multiple embedded electrodes configured to target the median and radial nerves, and (3) a cloud-connected base station which charges the stimulator and securely transmits all device data to a cloud platform (All patients in the TX arm completed standard TAPS training with the Cala Trio device. The training included instructions to perform postural holds before and after stimulation sessions for measuring tremor power, self-administer 40-minute stimulation sessions as needed to control their tremor, report complaints, and a reminder to continue with any other ET-related care and comorbidity management recommended by their physician. Patients in the TX arm were instructed to use the device as-needed according to the instructions for use, which states that “Cala Trio therapy should be applied when temporary relief of hand tremor is desired (i.e., before activities involving your hands such as meals or writing).” Patients in the SOC arm were given instructions to measure tremor power once a day with the Cala Trio device, without delivering stimulation, for one month. Additional study-specific training was given to both arms and included instruction on completing a Bain & Findley Activities of Daily Living (BF-ADL) upper limb rating assessment scale at baseline and one month, and notifying study personnel of any therapy modifications, as applicable. The wording used on the BF-ADL survey for the upper limb tasks and ratings matched that from the original publication [ | PMC10588491 | |
Data Collection | ADVERSE EVENT | Demographic and clinical data were collected either directly from patients or abstracted from the patients’ medical and pharmacy claims in the health plan’s administrative claims database and entered into the electronic Case Report Form (eCRF) by trained study personnel. Comorbid conditions in the medical claims were identified using previously described methods based on ICD-10-CM [The BF-ADL upper limb scores were collected using patient surveys administered on the e-consent platform at baseline and the end of one month. The eight BF-ADL upper limb tasks assessed were to (1) use a spoon to drink soup, (2) hold a cup of tea, (3) pour milk from a bottle, (4) dial a telephone, (5) pick up change, (6) insert an electric plug, (7) unlock front door, and (8) write a letter. Each task was rated on a scale of 1 (“able to do the activity without difficulty”), 2 (“able to do the activity with little effort”), 3 (“able to do the activity with a lot of effort”), to 4 (“cannot do the activity by yourself”) [Adverse events (AEs) were self-reported by patients and were entered into the electronic Case Report Form (eCRF) by trained study personnel. | PMC10588491 | |
Statistical Analyses | SECONDARY | Analyses were performed according to a prespecified statistical analysis plan. Descriptive analyses present distributions as frequency (%) for categorical variables and means with standard deviations (SDs) or medians with interquartile ranges (IQR), as appropriate, for continuous variables. Differences between the study arms and between the subgroups (age, gender, severity) were tested using either a two-sample t-test or the Wilcoxon rank-sum test for continuous variables and Pearson xThe pre-specified modified intention-to-treat (mITT) analysis population for the primary and secondary endpoints included all the patients who completed one month of study. The per-protocol (PP) analysis population included all participants from the mITT population who adhered adequately to the protocol. In the SOC arm, participants who purposefully or accidentally initiated more than one therapy session greater than or equal to 5 minutes in duration during the month were excluded from PP analysis. In the TX arm, participants who completed only one TAPS session or no TAPS sessions during the month were excluded from PP analysis. The rationale is that these TX patients would not have complied with the study protocol of using TAPS as needed beyond the training session. If a TX patient completed at least two TAPS sessions of at least 5 minutes duration during the month, they were included in the PP analysis. | PMC10588491 | |
Primary Endpoint | tremor, Tremor | The study’s pre-specified primary endpoint was the difference in median tremor power for patients in the TX versus SOC arm in the mITT, with statistical significance evaluated using a Wilcoxon rank-sum test. Tremor power for each patient in the TX arm was the median tremor power measured during postural holds performed after each self-administered TAPS session over the month of home use. Tremor power for each patient in the SOC arm was the median tremor power measured during postural holds performed daily over the month of home use. Tremor power for both arms was summarized as a geometric mean and geometric standard error, equivalent in range to the mean and standard error of log-transformed data, because tremor power is logarithmically distributed. | PMC10588491 | |
Secondary Endpoint | SECONDARY | The study’s pre-specified secondary endpoint was the difference in BF-ADL upper limb score improvement from baseline to the end of the first month for patients in the TX arm versus the SOC arm in the mITT, with statistical significance evaluated using a two-sample t-test. BF-ADL upper limb scores for both arms were summarized using the mean and standard deviation. | PMC10588491 | |
Exploratory Endpoints | tremor, TPIR | Pre-specified exploratory analyses of BF-ADL scores in the mITT included assessment of improvement in BF-ADL score from baseline to one month within each arm, and improvement in individual BF-ADL tasks from baseline to one month within each arm. A two-sample t-test with Holm-Bonferroni corrections for multiple hypothesis testing was performed to compare the total and per-task changes in BF-ADL scores from baseline to the end of the month between the TX arm and SOC arm.Pre-specified exploratory analysis of tremor power in the mITT included assessment of improvement within the TX arm. Each patient’s improvement was defined as the median tremor power improvement ratio (TPIR) across all of that patient’s TAPS sessions, where TPIR was the ratio of tremor power before stimulation to after stimulation [ | PMC10588491 | |
Severe ET Subgroup Analyses | SECONDARY | A subgroup of more severe patients was defined as patients who scored a 3 or 4 on at least one of four BF-ADL tasks associated with eating, drinking, or writing at baseline. These included: (1) write a letter, (2) use a spoon to drink soup, (3) hold a cup of tea, and (4) pour milk from a bottle. The primary and secondary endpoints were analyzed within this subgroup and further stratified by age. | PMC10588491 | |
TAPS Device Usage Analysis | Usage in the TX group, as pre-specified, was assessed as the number of therapy sessions per week, total days per week with at least one therapy session, and the average number of therapy sessions per day on days therapy was used. Usage assessments were further stratified by age and gender. | PMC10588491 | ||
Sample Size Calculation | The study sample size was calculated to sufficiently power the study’s primary endpoint. A 25% patient attrition was assumed based on the one-month dropout rate in a previous study [ | PMC10588491 | ||
Results | PMC10588491 | |||
Secondary Endpoint | ± | SECONDARY | The secondary endpoint was also met in both the mITT and PP populations. 134 of the 276 patients completed the BF-ADL ratings at baseline and one month. The changes in BF-ADL score from baseline to one month in the TX arm (1.6 ± 0.43, N = 51) were significantly greater than the changes observed in the SOC arm (0.22 ± 0.37, N = 83) ( | PMC10588491 |
Severe ET Subgroup Analysis | tremor | SECONDARY | TAPS significantly improved tremor power in the severe subgroup, in which tremor power was 0.02 (0.003) (m/sSevere subgroup analyses of primary and secondary endpoints between TX and SOC arm in the mITT population** Severe patients were classified as having at least one of 4 tasks which impacts eating, drinking, or writing BF-ADL task ≥3.** Includes patients with complete BF-ADL scores from baseline and at one month.Moreover, patients in the severe subgroup that were aged 65 and above exhibited a 5-fold greater improvement in tremor power in the TX arm than the SOC arm ( | PMC10588491 |
Adverse Events | dizziness, skin irritation, sores | ADVERSE EVENTS, EVENTS | Four patients (3%) reported temporary wrist skin irritation, sores, discomfort, or dizziness including unpleasant stimulation during the one-month study period. All these events were resolved without professional medical attention. No TAPS therapy-related serious adverse events reported. | PMC10588491 |
Discussion | tremor, Tremor, tremors | ADVERSE EVENTS | This was the first randomized pragmatic clinical trial comparing TAPS to SOC in patients with ET, as well as the first randomized TAPS study that included use of TAPS at-home. The study demonstrated that adding TAPS therapy to SOC significantly improved tremor power and BF-ADLs compared to SOC alone during one month of home use, in both the mITT and PP populations (This study demonstrated how motion sensors can be used to measure tremor power over extended home-use and as an endpoint to evaluate the effectiveness of TAPS therapy or other interventions for ET in clinical trials [Motion sensors have been widely used to quantify tremor severity in ET patients [Tremor power improvement measured using motion sensors in this study was slightly lower than previously reported clinical trial findings. In this study, 45% of patients demonstrated tremor power improvement greater than 2-fold (The efficacy and therapy usage can be markedly influenced by the patient selection criteria. For example, a previous study involving a more severe ET population observed a greater improvement in BF-ADL scores with TAPS therapy [Patients with the most severe tremors had the greatest tremor reduction when they received TAPS therapy, which aligns with previous studies [These results are consistent with the growing body of evidence suggesting that TAPS therapy is a safe and effective option for ET patients who are interested in a treatment with less adverse events than current medications and neurosurgical interventions [ | PMC10588491 |
Limitations | non-conscious | There are several limitations associated with this randomized pragmatic clinical trial run during the COVID-19 pandemic that could affect interpretation of these results. First, the open-label design could be confounded with bias, including non-conscious communication of positive biases to patients and biases by study personnel in reporting, data collection, and statistical analysis [ | PMC10588491 | |
Conclusion | SOC reduced tremor | This is the first randomized large-scale pragmatic clinical trial to evaluate unsupervised TAPS use in a real-world home-base setting. The study demonstrated that adding TAPS therapy to existing SOC reduced tremor power and increased improvements in BF-ADL upper limb scores during one month of home use compared to SOC alone. These findings expand and reinforce the prospective and real-world studies suggesting TAPS is a safe and effective treatment option for patients with ET. | PMC10588491 | |
Meeting Presentation | Parkinson’s Disease | MOVEMENT DISORDERS | These data have previously been presented as posters at the International Congress of Parkinson’s Disease and Movement Disorders, Madrid, Spain, September 15–18, 2022, and the AMCP 2023, San Antonio, TX, March 21–24, 2023. | PMC10588491 |
Additional File | The additional file for this article can be found as follows:Table S1–S2 and Figure S1–S3. | PMC10588491 | ||
Funding Information | This study was sponsored by Cala Health, Inc. | PMC10588491 | ||
Competing Interests | D Dai, J Fernandes, and H Coetzer are employees of CVS Health Clinical Trial Services LLC, which received funding from Cala Health, Inc. to complete this research. H Kim is an employee of Cala Health Inc. at the time the study was conducted. The authors report no other potential conflicts of interest. | PMC10588491 | ||
1. Introduction | pre-eclampsia, anxiety, multisystem disorder, depressive symptoms, depression | PRE-ECLAMPSIA, PRE-ECLAMPSIA | Objective: This study aims to extend the understanding of the psychological impact of the first-trimester pre-eclampsia (PE) screening on women identified as high risk for preterm PE. We examined the differences between low- vs. high-risk women throughout pregnancy in: symptoms of distress (anxiety, depression, physical and mental health, and worry), health behaviour changes, the experience of pregnancy, and attitudes towards PE screening. Methods: This study was nested within the ASPRE trial. Pregnant women were screened for preterm-PE risk status in the first trimester; the assessments were carried out before the screening, in the second and in the third trimester (n = 155 low-risk women and N = 82 high-risk women in the second trimester). Results: The high-risk-for-PE women exhibited more depressive symptoms compared to the low-risk women in the second but not in the third trimester. No differences were observed between the two groups in other distress symptoms or in the women’s evaluation of their experience of pregnancy. The high-risk group reported greater health behaviour changes compared to the low-risk group, but this was moderated by depression levels. Conclusions: Overall, pregnant women reported positive attitudes towards first-trimester PE screening, despite transient depressive symptoms. This study offers supportive evidence concerning the appropriateness of PE screening in ethical terms.Pre-eclampsia (PE) is a multisystem disorder that affects 2–5% of pregnancies and is one of the main causes of maternal and foetal morbidity and mortality [First-trimester screening for PE offers opportunities for the early identification of women at high risk, who can then be offered intensive surveillance and aspirin prophylaxis starting from the first trimester of pregnancy [To date, there have only been two studies [There is currently a scarcity of research regarding the factors that impact women’s health behaviours before and during pregnancy [The aim of the current study was to extend the understanding of the psychological impact of the first-trimester PE screening on women. Simeone and colleagues [ | PMC10094560 |
2. Materials and Methods | PMC10094560 | |||
2.1. Study Design and Sample | Pre-eclampsia | PRE-ECLAMPSIA, PREGNANCY LOSS | This study was nested within the ASPRE (Aspirin for Evidence-Based Pre-eclampsia Prevention) trial; the study inclusion criteria and procedure were published previously [The current study was conducted in the UK in two ASPRE-trial-participating hospitals. The only departure from the described ASPRE trial study inclusion criteria [Consecutive pregnant women (n = 585) attending their 11–14 weeks ultrasound appointment at a London hospital participating in the ASPRE trial were offered the opportunity to be screened for preterm-PE risk status and those with the high-risk status were invited to participate in the trial and in the psychological study. Out of 585 women, 225 (38.4%) completed the first study questionnaire; following the exclusion of women (n = 6) who did not meet the study inclusion criteria (e.g., twin pregnancies or pregnancy loss diagnosed during ultrasound examination), 197 (87.2%) were identified as low risk for preterm PE, and 28 (12.8%) were identified as high risk for preterm PE. Because of the few high-risk cases in the recruited sample, additional high-risk women were recruited from another ASPRE-trial-participating hospital in London (N = 54), who completed questionnaires in the second trimester. Out of the 197 questionnaires completed by the low-risk women before screening, 155 were returned in the second trimester; the total number of returned questionnaires by the high-risk group was 82 ( | PMC10094560 |
2.2. Procedure | Women attending their routine 11–13 ultrasound appointment were offered the opportunity to be screened for preterm-PE risk status as part of the ASPRE trial. They were informed about the aims of the psychological evaluation that was carried out independently from the medical research. Participants who consented to taking part were asked to complete study questionnaires on three occasions during their course of pregnancy. The first questionnaire (time 1) was completed at 11–13 weeks, before PE screening. The results of the PE screening test were given to the participants during the first-trimester ultrasound examination. The result was either high risk for PE (>1 in 100) or low risk for PE. The high-risk group received medical counselling from a doctor regarding their risk status, its meaning, and the consequences. As part of the ASPRE trial, women at high risk for preterm PE were offered to be randomised into one of two groups: (a) daily low-dose aspirin (150 mg) until 36 weeks’ gestation or (b) a placebo group. A second questionnaire (time 2) was completed at 20–24 weeks when the women attended a hospital appointment or were mailed the questionnaires along with a prepaid envelope. The third questionnaire (time 3) at 28–32 weeks was posted to the participants’ home address. The local National Health Service research ethics committee granted ethics approval for this study (ref: 14/LO/1238). | PMC10094560 | ||
2.4. Data Analysis | high-risk-for-preterm-PE, depression | REGRESSION, RECRUITMENT | To examine the impact of first-trimester PE screening and prevention throughout pregnancy, we first examined the background differences across relevant demographic and obstetrics factors between the low- and high-risk-for-PE women (at time 2) using Student’s Given the identified differences between the low- and high-risk-for-preterm-PE groups regarding health behaviour changes, two-way analyses were carried out to examine the interaction at time 3 between risk status (high vs. low PE risk) and depression on lifestyle changes. Continuous variables were standardized before being inserted and multiplied in the regression model and the following variables were inserted as covariates in order to statistically control for their confounding effects: maternal education, employment, relationship status, whether it was their first child, and previous emotional difficulties.Finally, to ensure results were not inflated by the two-step recruitment of participants in the high-risk group, we performed the same analytic strategy as described above on the subsample of high-risk and low-risk participants recruited and longitudinally assessed across All analyses were performed using R [ | PMC10094560 |
4. Discussion | generalised, lower depression, anxiety, depressive, depressive symptoms, depression | RECRUITMENT, BLIND | Although it has been well documented that first-trimester PE screening is of clinical value [The study findings revealed that, among the various psychological distress outcomes considered, women identified to be at high risk for PE during the first-trimester screening exhibited more depressive symptoms at 22 weeks of pregnancy compared to low-risk women. These symptoms were transient as no significant differences between the low-risk- and high-risk-for-PE groups were identified in the third trimester. No differences between the two groups in anxiety, mental health, or worry about own or baby’s health were identified at any point of assessment. There were differences in the physical health in the first and third trimesters between the two groups of women, but these could be seen as cohort effects rather than “true” differences as such differences were present at baseline, before the PE screening test result was known. Our findings showcasing no elevations in anxiety levels are aligned with the findings of Simeone and colleagues, who reported that there is no adverse impact of the “high-risk” PE status on women’s anxiety levels [Our study identified that the high-risk-for-PE group reported to have made more changes to their health behaviours compared to women at low risk for PE. The questions relating to health behaviours mostly focused on dietary changes (eating more healthily; consuming less salt and fat and more fibre). It is important to note that medical professionals did not explicitly recommend changes to health behaviours to women at high risk for PE during antenatal screening. In line with suggestions that pregnancy can offer “teachable moments” for health behaviour change [We hypothesized that engagement in health behaviour change would be moderated by women’s depression levels. This hypothesis was supported as, amongst high-risk women, those reporting higher depression scores were significantly less likely to report having made changes to health behaviours in the second and third trimester in comparison to women with lower depression scores. Thus, although a high-risk test result may trigger changes in health behaviours, this could be hindered by the depressive symptoms experienced by the woman. This is an important finding as it suggests that depressive states may reduce the sense of agency and behavioural control that women will display during pregnancy, and that affected women will be less likely to engage in changes in health behaviours that would support their own health and that of their unborn child. This finding is concordant with a recent study [We found that the majority of women, regardless of their PE risk status, reported having had a positive experience of pregnancy and most of them endorsed the benefits of screening as outweighing the perceived costs. The majority also stated they were likely to request PE screening in a future pregnancy and recommend it to pregnant friends and relatives. Others have also reported that, generally, pregnant women, as well as those at high risk for PE, hold positive views in relation to PE screening in pregnancy [Our study findings offer unique insights not only towards a better understanding of the psychological impact of first-trimester PE screening on pregnant women, but also offer supportive evidence concerning the appropriateness of such a screening in ethical terms. From an ethical standpoint, the benefits of introducing novel screening programmes should be weighed against the potential harm for those women falsely screened as positive [Our findings need to be considered in light of the study limitations. Despite the considerable sample size overall, attrition in the study was significant and led to small sample sizes, particularly in the high-risk group during the last evaluation phase. The low incidence of the high-risk-for-PE status and the adopted longitudinal study design offered further challenges to the recruitment of the high-risk-for-PE cohort. Due to the loss of participants over time and the variability in participants at each time point of assessment, we were unable to treat our data as “truly” longitudinal and our data analytic strategy was adjusted to address that shortcoming in the main data set. We then also analysed the smaller subsample of the high-risk women who met the criteria of the prospective longitudinal design and were able to identify a very similar set of findings. Issues relating to recruitment and attrition will remain a challenge for researchers examining the impact of PE screening. The strength of our study is that a large number of confounders were included in the analyses, which gives confidence to the validity of our findings. Our study sample was predominantly White and well educated, and it is not possible to know to what extent our findings can be generalised to more ethnically, socially, and economically diverse populations. In addition, our study was nested within the ASPRE trial, an RCT for the prevention of PE using low-dose aspirin vs. a placebo. The women in our study were “blind” to whether they were taking aspirin or a placebo, but all of the high-risk women were offered additional monitoring and scans throughout pregnancy, which they found reassuring and beneficial [ | PMC10094560 |
5. Conclusions | depression, anxiety, depressive symptoms | ADVERSE EFFECTS | Our study offers novel insights concerning the psychological impact of the first-trimester screening for PE. The findings revealed that, overall, pregnant women had positive attitudes towards PE screening, and that the pregnancy experiences of those identified to be at high risk following the first-trimester PE screening were comparable to those identified as low risk. High-risk women reported more positive health behaviour changes compared to low-risk women subsequent to the positive test result, but this was moderated by the depression levels. Although no adverse effects of the “high-risk status” for anxiety, physical and mental health, and worry were identified, there was a transient increase in depressive symptoms in the second trimester of pregnancy among the high-risk women. Future studies conducted in routine clinical practice and utilising larger and more diverse samples would provide a definitive answer as to whether this increase in depressive symptoms is indeed of a transient nature or not. | PMC10094560 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10094560 | ||
Author Contributions | A.V.N. and K.H.N. designed the study. C.M., C.S. and A.V.N. analysed the data. A.V.N. wrote the paper with the help of other authors (C.S., C.M., N.O., L.C.P., K.H.N.). A.V.N. will act as guarantor for the paper. All authors have read and agreed to the published version of the manuscript. | PMC10094560 | ||
Institutional Review Board Statement | NRES Committee London—Surrey Borders ref 14/LO/1238 (date of favourable ethics opinion: 13 August 2014). | PMC10094560 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10094560 | ||
Data Availability Statement | Data are available on request to the corresponding author. | PMC10094560 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10094560 | ||
References | Depression | PREECLAMPSIA | Simple slope analysis for Risk group x Depression interaction at time 3 on Life-Style Behaviours. Note: PE = preeclampsia; PE risk group 1 = low risk of preeclampsia/PE risk group 2 = high risk of preeclampsia.Baseline sociodemographic characteristics of the included population (N = 282) by group.Note. data are given as No. (%), mean (SD); Group (low and high PE risk) differences in mental health indexes across pregnancy time points.Note. Data are given as mean (SD); Group (low and high PE risk) differences in lifestyle-related behavioural changes after PE screening at times 2 and 3.Note. Data are given as mean (SD); Group (low and high PE risk) differences in attitude toward PE screening at time 3.Note. Data are given as N (%); | PMC10094560 |
Abstract | PMC10476902 | |||
Background | lung cancer | LUNG CANCER | A recent trend in postoperative analgesia for lung cancer surgery relies on regional nerve blocks with decreased opioid administration. Our study aims to critically assess the continuous ultrasound-guided | PMC10476902 |
Patients and methods | lung cancer, cough, ESPB, pain | LUNG CANCER, SECONDARY | A prospective randomized-control study was performed to compare outcomes of patients, scheduled for video-assisted thoracoscopic (VATS) lung cancer resection, allocated to the ESPB or ICNB group. Primary outcomes were total opioid consumption and subjective pain scores at rest and cough each hour in 48 h after surgery. The secondary outcome was respiratory muscle strength, measured by maximal inspiratory and expiratory pressures (MIP/MEP) after 24 h and 48 h. | PMC10476902 |
Results | ESPB | 60 patients met the inclusion criteria, half ESPB. Total opioid consumption in the first 48 h was 21. 64 ± 14.22 mg in the ESPB group and 38.34 ± 29.91 mg in the ICNB group (p = 0.035). The patients in the ESPB group had lower numerical rating scores at rest than in the ICNB group (1.19 ± 0.73 | PMC10476902 | |
Conclusions | ESPB, pain | POSTOPERATIVE COMPLICATIONS | In the first 48 h after surgery, patients with continuous ESPB required fewer opioids and reported less pain than patients with ICNB. There were no differences regarding respiratory muscle strength, postoperative complications, and time to hospital discharge. In addition, continuous ESPB demanded more surveillance than ICNB. | PMC10476902 |
Keywords | PMC10476902 | |||
Introduction | lung cancer, empyema, ESPB | LUNG CANCER, EMPYEMA, PLEURAL INFECTION | Post-operative analgesia is crucial for early rehabilitation in thoracic surgery, as patients are required to actively participate in respiratory physiotherapy.In an attempt to find safe and less invasive methods of postoperative analgesia, new techniques of nerve blocks have emerged. Among other peripheral blocks, intercostal nerve block (ICNB) and The ICNB applied intrathoracically at the end of the surgery, is a regional technique currently used for video-assisted thoracoscopic (VATS) procedures at our surgical center. While fairly simple to use and applied under direct vision, there are some disadvantages of the ICNB: limited time of analgesic effect, which cannot be extended by a continuous infusion, application at the end of surgery instead of pre-incision and multiple injections that are needed to pertain a single block. The block cannot be executed in the presence of pleural infection, e.g., empyema.The We compared the continuous ultrasound-guided ESPB with ICNB to evaluate their analgetic efficacy in patients after lung cancer resection, representing our institution's first study of continuous ESPB in Slovenia. We present the following article in accordance with the CONSORT reporting checklist. | PMC10476902 |
Patients and methods | The study was approved by the National Ethics Committee under the number 0120-372/2019/7 and the study was registered to the Clinical Trial Registry under number NCT04665531. | PMC10476902 | ||
Patients | inflammation, allergy, ESPB | INFLAMMATION, ALLERGY, LOCAL ANESTHETIC SYSTEMIC TOXICITY, CHRONIC PAIN SYNDROME | Sixty participants were enrolled between the 19Other inclusion criteria were ASA status I–III and informed written consent for participation in the study. Exclusion criteria were chronic pain syndrome, chronic opioid use, weight less than 50 kg due to risk of local anesthetic systemic toxicity (LAST), body mass index (BMI) > 35, pregnancy or breastfeeding, allergy to local anesthetics, inflammation at the catheter insertion site or inability to use the patient-controlled analgesia (PCA) pump. Patients were randomly assigned to either the intervention ESPB arm or the comparative ICNB arm. The study protocol could not be blinded because of the indiscrete intervention type. | PMC10476902 |
Nerve block technique | tumor, ESPB | STERILE, TUMOR, PERIOSTEUM, INFILTRATED | Patients in the ICNB group received a single-shot intrathoracic ICNB after tumor extraction, approximately 30 minutes before the end of the surgery. They received 20 ml of 0.5% levobupivacaine with injections at 6 intercostal spaces, adjacent to the surgical wound. The perineural intercostal space was located under direct vision. The same surgeon performed all the surgeries and executed the ICNBs.Patients in the ESPB group received a 20 ml bolus of 0.5% levobupivacaine through the ESPB catheter approximately 30 minutes before the end of the surgery, continued by an infusion of 5 ml/h 0.2% ropivacaine with intermittent boluses of 15 ml per 4 hours.Two anesthesiologists, experienced in regional anesthesia, were inserting catheters to the patients before the surgery in the pre-op area. The standard monitoring and i.v. canal were applied before the intervention. The ESPB catheter insertion was performed using Samsung© ultrasound with a GE 12L-RS high-frequency linear probe. Aseptic conditions were guaranteed by using sterile drapes, sterile probe dressings, gloves, masks, and surgical gowns. The catheter insertion underwent in a pronated position with the patient lightly sedated by 1–2 mcg/kg fentanyl. The insertion site was infiltrated with 2 ml of 2% lidocaine on the T4 level of the spine, approximately 3 cm ipsilateral from the midline on the transverse process. The needle was then inserted under ultrasound guidance, positioning the needle tip immediately above the periosteum. The position was confirmed by injecting approximately 10 ml of 0.9% sodium chloride solution, which caused a hydro-dissection between the Ultrasound image of the inserted ESPB catheter (marked by an arrow) and interfascial hydro-dissection.1 – underlying thoracic lamina, 2 – m. | PMC10476902 |
Peri-operative protocol | ESPB, neuromuscular block, pain, cough, infection, NRS | BLOOD, INFECTION | All the patients underwent the same anesthesia protocol. Induction to general anesthesia was conducted with 1.5–2 mg/kg propofol 1% and 0.75–1 mcg/kg remifentanil in a slow bolus followed by 0.6 mg/kg rocuronium. Total intravenous anesthesia was maintained with an infusion of 5 mg/kg/h propofol 1% and 0.02–0.03 mcg/kg/min remifentanil. Blood pressure was maintained with fluid administration and appropriate vasoactive drugs when needed. Reversion of neuromuscular block was performed by a bolus of 2 mg/kg sugammadex at the end of the surgery.Patients were constantly monitored (ECG, pulse oximetry, invasive blood pressure) from admission to the pre-op area until at least 48 hours after surgery. Nurses at the intensive care unit documented the post-operative numerical rating scale for pain (NRS) every hour in the first 48 hours except when the patient was asleep. The patients expressed their current NRS on a scale from 0 to 10 with 0 meaning no pain and 10 meaning the worst pain imaginable. Nurses asked the patients about their NRS at rest and at cough in the last hour, which included spontaneous and active cough but not respiratory physiotherapy.Every patient received a PCA pump with the protocol: demanded bolus 3 mg piritramide 1 mg/ml per 15 min with a maximum of 2 boluses per hour with no continuous infusion. If the pain reported by a patient was still higher than 3/10, a nurse applied an additional bolus of 3 mg piritramide. When a patient demanded more than 4 boluses per hour, the attending doctor initiated an infusion of 2 mg/h piritramide until the pain settled below 3/10. All the patients received regular doses of diclofenac and metamizole in terms of multimodal analgesia.The postoperative care of the ESPB catheter followed the same protocol as for the thoracic-epidural catheter. The attending physician evaluated the catheter insertion site every day, looking for signs of infection.All the patients performed maximal inspiratory and expiratory pressure (MIP/MEP) tests three times: on the day of the surgery prior to the surgical procedure, 24 and 48 hours later. | PMC10476902 |
Statistical analysis | The statistical analyses were performed using IBM SPSS version 25, Orange data mining and visualization suite. | PMC10476902 | ||
Results | bleeding, ESPB, infections, sinus tachycardia, cough, arrhythmias, NRS | BLEEDING, SINUS TACHYCARDIA, INFECTIONS, ARRHYTHMIAS, PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA, COMPLICATIONS | Patient allocation and follow-up are shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram (CONSORT flow diagram.ESPB There were no statistically significant demographic differences between the study groups considering gender, age, body mass index, type of surgery, ASA and forced expiratory volume in the first second (FEV1) (Demographic dataValues under age, height, weight, and BMI are given as mean and 95% confidence interval.ASA = American Society of Anesthesiologists assessment; BMI = body mass index; ESPB = The cumulative piritramide use in the first 48 hours after surgery was 21.64 ± 14.22 mg in the ESPB group and 38.34 ± 29.91 mg in the ICNB group (p = 0.035) (Cumulative piritramide use in the first 48 hours after surgery. The values in the graph are marked as mean (blue), median (yellow), and interquartile range.ESPB Cumulative opioid consumption in the first 48 h after surgery. The bold line shows the median values for each group.The mean NRS scores at rest in the first 48 hours after surgery were 1.19 ± 0.73 in the ESPB group and 1.77 ± 1.01 in the ICNB group. The difference between groups is statistically significant (p = 0.039). The mean NRS scores at cough in the first 48 hours after surgery were 2.53 ± 1.23 for ESPB and 2.85 ± 0.98 for ICNB. The difference between groups is statistically insignificant (p = 0.432).There were no statistically significant differences between the ESPB and ICNB groups in MIP or MEP after 24 or 48 hours (Maximal inspiratory and expiratory muscle strengthRespiratory test values are expressed as percentages from the baseline value.ESPB Time to chest tube removal was 4.13 ± 2.92 days in the ESPB group There were no catheter-related complications such as clogging of the catheter, unintentional removal, or insertion-site infections. Attending physicians noted a few cases of minimal bleeding under the see-through coverings.In the ESPB group, they noted one case of paroxysmal atrial fibrillation, one case of paroxysmal supraventricular tachycardia, and one case of sinus tachycardia at the time of observation. In the ICNB group, they noted 6 cases of paroxysmal atrial fibrillation. These arrhythmias emerged on postoperative day 1 or 2. | PMC10476902 |
Discussion | lung cancer, cardiac arrhythmias, ESPB, cardiotoxicity | LUNG CANCER, CARDIAC ARRHYTHMIAS, RECRUITMENT, COMPLICATIONS | This study of postoperative analgesia for VATS lung cancer resection, comparing continuous ultrasound-guided ESPB versus ICNB, is the first of its kind in Slovenia. Due to the Covid-19 pandemic crisis, causing limited resources and additional healthcare concerns, the time of patient recruitment was prolonged, and only 60 patients from 200 were eligible for our study in a two-year period. The most significant findings were lower opioid demands in the ESPB group (21.64 ± 14.22 mg In recent years, some studies were comparing single-shot ICNB and ESPB with unclear advantages. In terms of postoperative opioid use, the ICNB was reported by some studies to be more efficient and by other studies to be less efficient than the ESPB.Our results are consistent with Fiorelli The mean piritramide use between the groups started to differentiate after 12 hours postoperatively, marking the time when the ICNB effect wears out. Other observed parameters, such as time to chest tube removal, hospital discharge, and complications were similar in both groups. However, continuous ESPB is more demanding from the catheter insertion procedure to regular post-operative observations.Despite the continuous neuromuscular block of the hemi-thoracic musculature, the ability to fully perform respiratory physiotherapy was not compromised by the continuous ESPB. MIP and MEP measurements decreased substantially but did not differ significantly between the two groups after 24 hours or after 48 hours. Because the absolute MIP and MEP results vary strongly in literature, we included relative values with the patients’ pre-operative measurements as the baseline.As common complications after lung resection, cardiac arrhythmias were monitored.Comparing ESPB to a placebo without regional anesthesia would be unethical considering the benefits of regional truncal blocks that have already been proven.The main limitation of the study is the inability to double-blind the analgesic method because of the catheter. The second limitation is the number of included patients. It would be reasonable to conduct another study on a larger scale to see whether any other inter-group differences appear. The third limitation is the protocol for the continuous ESPB, which is subject to future changes regarding local anesthetic selection and administered volume. Ropivacaine is currently the best local anesthetic of choice because of its large safety profile and the lowest potential risk for cardiotoxicity | PMC10476902 |
Conclusions | cough, ESPB, pain | LUNG TUMOR | The study in our institution showed that the continuous ESPB decreases total opioid consumption and subjective pain perception at rest in the first 48 hours after VATS lung tumor resection compared to the intrathoracic ICNB. On the other hand, ESPB demands more nursing care. Regarding time to chest tube removal, hospital discharge, NRS values at cough and respiratory muscle strength, there were no observed differences between ICNB and ESPB. | PMC10476902 |
Acknowledgments | Authors would like to thank the doctors and nursing staff at the Surgery Bitenc Clinic who contributed to the study's final realization.Disclosure: No potential conflicts of interest were disclosed. | PMC10476902 | ||
References | PMC10476902 | |||
1. Introduction | Research suggests that mental activation of human social support may reduce stress reactivity. However, the extent to which social support from pets elicits a similar effect has been less explored. This study aims to determine whether the mental activation of one’s pet dog reduces stress reactivity to a subsequent experimental stressor. In a 2 × 2 design, 132 dog-owning participants (M | PMC10648142 | ||
1.1. Background and Significance | Social support has long been recognized as vital to human health and wellbeing [In addition to human social support, research has recently begun to examine the effect of animal-derived social support on stress reactivity. Historically, companion animals (i.e., pets) have been recognized as providers of instrumental social support by providing tangible services such as herding, guarding, hunting, etc. However, pets are increasingly recognized for their ability to provide emotional support, both in formal roles (e.g., as therapy animals) and as companion animals. Many pet owners in the US consider their pets members of their family [Indeed, studies have found that the presence of a friendly dog reduces self-reported and cardiovascular measures of stress reactivity during a stressful procedure compared to when alone [Existing studies examining the effect of companion animals on stress reactivity have focused on a single type of stressor. However, to our knowledge, there has not been a study directly comparing how animal-derived social support may differentially impact stress reactivity depending on the nature of the stressor (i.e., a cognitive stressor vs. a social stressor). A meta-analysis in 1999 found that human-derived social support was, overall, related to lower heart rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) reactivity but found evidence of significant moderators depending on the support provider and the type of stressor (i.e., conducting a speech versus performing arithmetic or anagrams) [ | PMC10648142 | ||
1.2. Mental Activation of Social Support | Because a supportive figure may not be physically present during all stressful situations that occur in life, of interest is the possibility that simply thinking about a social tie may be beneficial. Specifically, researchers have investigated if mentally activating an internal representation of social support (i.e., support schemas) may also significantly buffer stress reactivity to a stressor. In one of the first studies to investigate this, Smith et al. [In comparison to human social support, the effect of mental activation of animal-derived social support on stress reactivity has been much less researched. A seminal 2012 study conducted two experiments to determine if mentally activating an attachment relationship with a pet could provide similar benefits as having a pet physically present. The study found that participants who wrote about their relationship with their pet prior to the stressor (cognitive presence) and participants who had their pet present (physical presence) both had lower blood pressure during the task compared to a control group [ | PMC10648142 | ||
1.3. Aims of the Current Research | The first aim of the current study was to determine whether mental activation of one’s pet dog reduces stress reactivity during a mild stressor. We hypothesized that individuals who completed a structured writing activity about their pet dog prior to completing a stressor would report higher positive affect and less cardiovascular stress reactivity in response to the stressor than those who completed a structured writing activity about a general positive memory. As a second aim, we assessed the extent to which the effect of this mental activation on stress reactivity may differ based on the type of stressor (social-evaluative or cognitive). | PMC10648142 | ||
2. Materials and Methods | PMC10648142 | |||
2.1. Participants | Participants were N = 132 dog-owning undergraduate and graduate students over the age of 18 attending a large public university in the United States. We restricted participants to dog owners to provide consistency and because relationships with pet dogs tend to be stronger than relationships with other types of pets [ | PMC10648142 | ||
2.2. Study Design | All protocols were approved by the Purdue University Institutional Review Board (Protocol #13-4660H). Participants were randomized to one of two mental activation conditions (asked to think/write about a memory of their pet dog or asked to think/write about any positive memory as a comparison) and to one of two stressor conditions (social-evaluative stressor or cognitive stressor). Randomization occurred via a random number generator (random.org). Participants were blinded to their assignment. Thus, all participants were asked to bring a digital or physical photo of their pet dog to the laboratory session regardless of which mental activation condition they were allocated. The research team was not blinded to participant assignment to conduct the correct protocols during each participant’s visit, which varied by assignment. The analyzed sample consisted of four groups: N = 37 cognitive stressor/pet dog mental activation group (Cog | PMC10648142 | ||
2.3. Procedures | All procedures occurred during a single visit to an observational laboratory over 35 min (After the mental activation phase, the stressor phase began. Participants were randomized to either a social-evaluative stressor or a cognitive stressor. Both stressors lasted approximately 15-min, and physiological data were collected every 3 min. At the end of the stressor, participants completed another self-report survey to indicate post-stressor affect.Participants randomized to the social-evaluative stressor were administered the Trier Social Stress Test (TSST) [Participants randomized to the cognitive stressor completed a mental arithmetic task and a solvable anagram task. During the 12-min mental arithmetic task, participants engaged in a series of subtractions (e.g., subtract seven from 6828) and were prompted to speed up their responses at the start of minutes three, seven, and eleven [ | PMC10648142 | ||
2.4. Measures | POSITIVE | Demographic information collected from participants included age, gender identity, and race/ethnicity. In addition, participants reported on health behaviors that are associated with physiological functioning (consumption of caffeine, alcohol, and nicotine over the 24 h prior to the visit, medication taken and physical activity the day of the visit, and hours slept the previous night).Participants reported on their emotional state via the 20-item Positive and Negative Affect Schedule (PANAS) [Because expert guidelines suggest a minimum of two different self-report measures to assess participants’ subjective stress state [Objective stress reactivity was measured via systolic and diastolic blood pressure (SBP, DBP) and heart rate (HR) to accompany subjective measures. A noninvasive fitted cuff monitor (Dinamap Pro 100V2, GE Medical Systems, Tampa, FL, USA) was used to measure BP and HR, replicating protocols from previous studies [ | PMC10648142 | |
2.5. Analytic Plan | All analyses were conducted in SPSS version 28.0 (IBM Statistics, Armonk, NY, USA). One-way ANOVA and chi-squared tests were used to ensure that randomization resulted in no significant between-group differences in demographic continuous and categorical variables. SBP, DBP, and HR data were screened for outliers, and outliers over three standard deviations above or below the mean were winsorized ( | PMC10648142 | ||
3. Results | Participants did not significantly differ in age ( | PMC10648142 | ||
4. Discussion | PHYSIOLOGICAL STRESS | The objective of this study was to determine to what extent mental activation of one’s pet dog reduces stress reactivity to a social-evaluative or cognitive stressor. Results suggested that participants who wrote and thought about their pet dog prior to an experimental stressor reported less of a decrease in positive affect from before to after the stressor compared to participants who wrote and thought about a general positive memory. However, this study found that mental activation conditions did not differ in the magnitude of change in other subjective stress measures (negative affect, negative self-evaluation) or physiological stress (SBP, DBP, HR). The impact of mental activation of a pet dog on stress reactivity was also not dependent on the type of stressor received (social-evaluative or cognitive). Findings from the current study differ from those of Zilcha-Mano and colleagues, who found that mental activation of one’s pet dog reduced subsequent cardiovascular reactivity during a stressor [Previous studies have found that mentally activating internal representations of a supportive human relationship can attenuate physiological stress reactivity during a stressor [Results lend evidence towards the possibility that the physical presence of a dog may be required to elicit a significant stress-reducing effect. Indeed, several studies have found significant stress-buffering effects of dog presence via reduced heart rate [Our second hypothesis, which stated that the stress-buffering effect of thinking about one’s pet dog would be more pronounced among individuals randomized to completing a social-evaluative stressor than those completing a cognitive stressor, was not supported. While we did find that participants who received the social-evaluative stressor had significantly larger increases in SBP compared to the cognitive stressor, there were no significant interactions between time, stressor condition, and memory condition. Therefore, the two stressors resulted in similar increases in cardiovascular stress reactivity regardless of the type of memory condition. It is important to note that although the TSST is described as a social stressor in the literature, it contains cognitive (i.e., mental arithmetic) components completed in a social-evaluative manner. In addition, the cognitive stressor may have contained a small social component given that the experimenter was required to correct the participant in response to an error. This overlap in the nature of the stressors may explain why an effect of stressor type was not found. It is possible that if we had chosen a purely social stressor task such as social exclusion, the pet dog condition may have been more impactful, e.g., [ | PMC10648142 | |
Limitations and Future Directions | Results of this study should be interpreted with the following limitations in mind. First, the sample was not representative; using non-probability convenience sampling, we obtained a sample that was 92% White, 80% female, and all dog-owning undergraduate or graduate students at a university. It is likely that there was also self-selection bias present, such that participants who volunteered for the study likely had a positive relationship with their pet dog. Therefore, findings are not generalizable to the larger population of dog owners. Second, group size was uneven due to limitations to randomization to four groups with a smaller sample. However, because these differences were not due to bias or non-random factors, implications for validity of the study’s findings are likely minimal. Finally, as pointed out by previous studies [ | PMC10648142 | ||
5. Conclusions | This study found that pet dog owners that mentally activated a memory with their pet dog reported less of a decrease in positive affect from before to after an experimental stressor compared to participants that mentally activated a general positive memory not featuring their dog, regardless of the type of stressor received. However, groups did not significantly differ in cardiovascular stress reactivity, including blood pressure and heart rate, nor in negative affect or negative self-evaluation. Second, the effect of mental activation of one’s pet dog did not significantly differ among those completing a social-evaluative stressor compared to those completing a cognitive stressor. Results suggest that mental activation of one’s pet dog may not be sufficient to elicit a social support schema to significantly impact cardiovascular stress reactivity. Future research is necessary to parse out the level at which individual differences and human–animal interaction characteristics may impact results. | PMC10648142 | ||
Author Contributions | Conceptualization, D.J.G. and R.G.L.-T.; methodology, D.J.G. and R.G.L.-T.; formal analysis, K.E.R.; investigation, R.G.L.-T.; writing—original draft, K.E.R.; writing—review and editing, K.E.R., D.J.G. and R.G.L.-T.; supervision, D.J.G. and R.G.L.-T. All authors have read and agreed to the published version of the manuscript. | PMC10648142 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Purdue University (Protocol #13-4660H, approved on 13 March 2014). | PMC10648142 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10648142 | ||
Data Availability Statement | Data are available on request. | PMC10648142 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10648142 | ||
References | Experimental procedure.Graphs displaying changes in positive affect (PA), negative affect (NA), and negative self-evaluation (NSE) from baseline to post-stressor across groups.Graphs displaying diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) during the baseline, mental activation, and stressor periods across groups.Descriptive statistics and statistical analyses output for self-reported measures across conditions.Note: CogDescriptive statistics and statistical analyses output for physiological measures across conditions.Note: Cog | PMC10648142 | ||
Abstract | vascular stiffness, cardiometabolic disease | OVERWEIGHT AND OBESITY | Overweight and obesity (Ow/Ob) is a risk factor for cardiometabolic disease. Caloric restriction (CR) have been investigated but little is known about the acute effects of CR and often such diets are not standardized. Thus, we aimed to assess the impact of a new standardized 3‐day CR diet (590 kcal/d intake) on cardiometabolic health in weight‐stable Ow/Ob individuals. In a single‐arm design, 15 Ow/Ob men and women were assessed pre‐post a 3‐day standardized CR diet; specifically, body weight/composition (%body fat, visceral fat score (Vfs), blood pressure (BP), and vascular stiffness (VS), resting energy expenditure (REE), substrate utilization (respiratory quotient, RQ), and blood glucose/lipid profile). CR lowered body weight (93.1 ± 15.2 to 90.67 ± 14.4 kg,
| PMC10659943 |
INTRODUCTION | metabolic inflexibility, overweight, metabolic dysfunction | OBESE, DISEASE | According to the Centers for Disease Control (CDC), more than 42% of adults are classified as obese, and approximately 74% of US adults are classified as overweight (body mass index of 25.0 to <30 kg/mObesity is associated with physiological disruption, specifically metabolic dysfunction such as impaired ability to use fat or metabolic inflexibility (Kelley et al., More recent work on short‐term (1–2 weeks) CR (700–1000 kcal/d intake) in Ow or Ob women suggests improved body weight and body composition CR (Jakobsdottir et al., Accordingly, the purpose of this single‐arm trial was to document the effects of a 3‐day very low‐calorie CR diet (<600 kcal/d) on body weight/composition, measures of cardiometabolic health as well as circulating regulatory factors that regulate hunger, satiety, and metabolism. We hypothesized that the 3‐day CR diet would induce favorable changes in body weight, body composition, metabolic function, via increased fat use, blood pressure, and blood glucose/lipid profile. This study could provide evidence on the acute efficacy of a novel 3‐day CR on body weight/composition, but also identify the potential underlying physiological mechanisms through which such dietary intervention may elicit cardiometabolic improvement. Collectively, this may provide a preliminary data for study of this diet with IF. | PMC10659943 |
METHODS | PMC10659943 | |||
Subjects and general procedures | Participants were recruited via email and publicly posted flyers from the Saratoga Springs, NY community. To be included participants must have been Ow or Ob (defined as BMI > 27.5 kg/mExperimental overview. ↓ perceptual survey was completed. | PMC10659943 | ||
Procedures | This study was an open‐label, single‐arm study design, see overview of the study procedures in Figure Participants were then positioned supine, and allowed to rest for 10 min, during this time we instrumented them with an oscillometric blood pressure cuff. Peripheral blood pressure, estimated central blood pressure and pulse wave analysis (Augmentation Index, AIx) (Shoji et al., Finally, participants were transported to the Health Services department to have a blood sample taken from an upper extremity. A small aliquot (40 μL) of fresh blood was used for blood lipid and glucose measurement using the cholestech ldx analyzer (Abbott, Lake Forest, IL, USA), which has been validated against standard clinical testing (Carey et al., Participants were then given the standardized diet, which was the Plexus 3‐day Reset diet program (Plexus Worldwide LLC, Scottsdale, AZ), and this marked the start of Day 1 (Monday or Tuesday). Details of the diet are provided in Tables | PMC10659943 | ||
Biomarker analysis | INSULIN RESISTANCE, ALDRICH | To estimate in vivo biological effects of the 3‐day CR, plasma samples were analyzed using commercially available assay kits for ketone bodies (b‐hydroxybutyric acid, BOH; and acetoacetic acid, AcAc; Sigma Aldrich, Burlington, MA), factors that regulate metabolism (insulin, thyroid stimulating hormone, cortisol; RayBiotech, Peachtree, GA), and factors that influence hunger/satiety (leptin, ghrelin, protein YY, neuropeptide Y; RayBiotech, Peachtree, GA). From glucose, mentioned above, and insulin the homeostatic model of assessment of insulin resistance (HOMA‐IR) was calculated using published formula (Matthews et al., | PMC10659943 | |
Data and statistical analysis | In a paired samples | PMC10659943 | ||
RESULTS | PMC10659943 | |||
Participants | The fifteen individuals who completed the study were nearly middle aged, with a relatively even split of men and women (Table Participant characteristics ( | PMC10659943 | ||
Impact of | The 3‐day CR diet significantly lowered body weight by 3% (The effect of the 3‐day CR diet on body weight (Panel a), body mass index (BMI, Panel b), body composition (Panels c–f), and waist‐hip circumferences (Panel g–i) in overweight/obese men and women ( | PMC10659943 | ||
Impact of | The 3‐day CR diet had no significant effect on peripheral systolic (pSBP; The effect of the 3‐day CR diet on peripheral (p, Panel a–c) and central (c, Panel d–f) systolic (SBP), diastolic (DBP), and mean arterial (MAP) blood pressures, heart rate (Panel g), augmentation pressure (Panel h), and augmentation index (Panel i) in overweight/obese men and women ( | PMC10659943 | ||
Impact of | The 3‐day CR diet had no significant effect on blood glucose (The effect of the 3‐day CR diet on blood lipids (Panels a–e) and glucose (Panel f) in overweight/obese men and women ( | PMC10659943 | ||
Impact of | The 3‐day CR diet had no significant effect on VOThe effect of the 3‐day CR Diet on resting metabolism (volume of oxygen consumed, VO | PMC10659943 | ||
Impact of | BLOOD | The 3‐day CR diet had no significant effect on 3‐hydroxybutryic acid, cortisol, insulin, neuropeptide Y, ghrelin, protein YY, or on sirtuin 1 (all: Blood assay biomarker analysis.
| PMC10659943 | |
Impact of | fullness, hunger, desire | The 3‐day CR diet had no significant effect on self‐reported perceptions or feelings of hunger, desire to eat, or fullness (all: | PMC10659943 |
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