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Cost analysis | fracture, numbness, loss of reduction, pain, carpal tunnel syndrome | REGRESSION, PRESSURE SORE, CARPAL TUNNEL SYNDROME | The costs of treatment consisted of additional visits to the hospital, imaging and other examinations, physical therapy, and operative treatment. The mean overall cost of treatment per patient in the VFUDC group was €1 307 and €717 in the FC group. Thus, the costs per patient of VFUDC were €590 (82%) higher than the costs of FC. The difference in median costs was €-156 (95% CI -303 to -9), again in favor of FC. The difference in means in a linear regression model of 15D at 2 years was 0.006 points (95% CI -0,05 to 0,06) and did not reach the MCID. Based on 15D at 2 years, FC produced 0.012 more QALYs compared to VFUDC.The mean number of additional visits to hospital per patient was 1.98 in the VFUDC group and 1.64 in the FC group. Additional visits were 21% more frequent in VFUDC than in FC group. The reason for additional visits in the hospital was contact from the patient due to pain, pressure sores and/or numbness of fingers. Further examinations and procedures were done as needed according to the evaluation by a consultant surgeon. The overall costs of these visits and associated additional imaging or other examinations related to the fracture were €443 per patient in the VFUDC group and €358 per patient in the FC group. The rate of patients who had received physical therapy after 24 months was 57% (25) in the VFUDC group and 37% (14) in the FC group. The total number of physical therapy contacts was 224 in the VFUDC group and 63 in the FC group. The mean number of physical therapy contacts was 10.4 for the VFUDC and 4.5 for the FC group and the median were 6 and 3, respectively. The costs of physical therapy were €17 472 in the VFUDC group and €4 914 euros in the FC group. The cost of physical therapy per patient was €397 in the VFUDC and €133 in the FC group.A total of 6 operations were performed in the VFUDC group due to loss of reduction within the intended casting period. All operations were performed using an anatomic volar locking plate (VLP). In the FC group, 4 operations were performed. No corrective osteotomies were performed in the FC group, whereas 2 osteotomies were performed in the VFUDC group during the two-year follow-up period. Two patients in the VFUDC group had electroneuromyography performed after the casting period ended, but none of the patients needed surgery due to carpal tunnel syndrome and no carpal tunnel release operations were performed during the follow-up period. The cost of a surgical operation for fracture was €2 092, and the cost of a corrective osteotomy was €3 997 euros. The cost of operations per patient in the VFUDC group was €467 and €226 in the FC group. Delayed surgery increased the cost of operative care in the VFUDC group by €182 per patient. Excluding the cost of surgeries and only considering additional costs due to physical therapy and additional visits and examinations, the overall cost of treatment per patient was 840 euros per patient in the VFUDC and 490 euros in the FC group, a difference of 71% between groups. | PMC10079055 |
Discussion | fracture, fractures, Colles’ fractures, pain | DISEASE, SECONDARY | In this randomized, controlled, multicenter study, we found a small, imprecise but consistent, difference between groups in all primary and secondary functional results (PRWE, 15D QD, and VAS) favoring FC. The primary outcome, PRWE at 24 months, showed a difference of 5.37 points. However, this did not reach the predetermined MCID of 11 points. Surprisingly, the fracture being in the dominant or non-dominant hand did not seem to influence PRWE at 24 months or predict outcome in the cumulative probability model. Overall, the rate of operative treatment, physical therapy and additional visits to the outpatient clinic, and additional imaging and other examinations was higher in the VFUDC group. This caused the mean cost of treatment to be substantially higher in the VFUDC group than in the FC group. The increase in QALY was produced with lower costs compared to VFUDC. In other words, VFUDC produces inferior QALYs at a higher cost. It should also be noted that QALYs tend to measure the cost burden of the overall course of the illness/treatment and may not therefore be fully applicable in assessing the individual burden of disease, especially in the early phases of the treatment. In our study, not only were the overall costs of visits and treatment higher, but patients in the VFUDC group more often reported feeling pain (26% vs 9%, p = 0 .04) and stiffness (9% vs 0%, p = 0.06) to yes/no questions compared to the FC group at 3 months, Raittio et al. [Current protocols concerning the non-operative treatment of DRF seem to vary greatly between countries, hospitals, and even surgeons. Different casting methods and positions have been used based on fracture morphology, and some authors have also advocated different approaches, for example, Colles’ fractures compared to Smith fractures, van Leeuwen et al. [Most patients 65 years and older with a DRF are suitable for non-operative treatment and the functional results of operative and non-operative treatment are similar in the older population, Stephens et al. [According to a Finnish study, the incidence rate of distal radius fracture among individuals aged 60 years and older in Oulu, Finland, was 585 per 100 000 people per year, Flinkkilä et al. [ | PMC10079055 |
Strengths and limitations | COMPLICATIONS | In this study, we enrolled 105 patients. The drop-out rate at 12 months was 18% (19) and 23% (24) at 24 months. This was a higher rate than we expected, and the number of patients in the FC group was therefore lower than expected in the power analysis. However, the drop-out rate did not exceed 30% for long-term follow-up and we may conclude that the risk of bias has not increased. The sample size we used does not, however, permit convincing conclusions for infrequent outcomes, such as the difference in the rate of complications between the two studied interventions, to be made. Additionally, the SD of our primary outcome, PRWE score at 24 months, was larger than anticipated and utilized in a priori power calculation. However, the functional results remained consistent regardless of this. | PMC10079055 | |
Conclusions | fracture, Colles’ type of DRFs, Colles’ type DRF | We found a slight, but consistent difference in functional results between the VFUDC and FC groups. Our results suggest that FC produces non-inferior results compared to VFUDC in the treatment of Colles’ type of DRFs at 2 years with fewer problems and unnecessary healthcare provider visits, and less treatment-related burden. Cost analysis revealed costs were nearly double in the VFUDC group compared to the FC group, mostly due to more frequent physical therapy, surgery, and additional visits to hospital and additional examinations. Regardless of the more frequent physiotherapy visits, the VFUDC group had consistently slightly inferior functional results. In conclusion, we recommend the use of FC in older patients with Colles’ type DRF. Moreover, careful critical consideration should be given to routine physiotherapy guidance among older patients with distal radius fracture. | PMC10079055 | |
Supporting information | PMC10079055 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial. | (DOC)Click here for additional data file. | PMC10079055 | ||
Description of changes to the published protocol. | (DOCX)Click here for additional data file. | PMC10079055 | ||
Inclusion and exclusion criteria for the trial. | (DOCX)Click here for additional data file. | PMC10079055 | ||
Photos of the casts used in the trial. | (DOCX)Click here for additional data file. | PMC10079055 | ||
Baseline data of patients included in the final analysis. | (XLSX)Click here for additional data file. | PMC10079055 | ||
Initial trial protocol. | (DOC)Click here for additional data file.Lauri Raittio, M.D., Joni Hirsimäki, M.D. | PMC10079055 | ||
References | PMC10079055 | |||
Subject terms | microalbuminuria, diabetic nephropathy | BLOOD, DIABETIC NEPHROPATHY | The aim of the present study was to investigate the effect of linagliptin on microalbuminuria in patients with diabetic nephropathy (DN). The present double-blind randomized placebo-controlled clinical trial was performed on 92 patients with DN who were divided into two groups. The intervention and control groups received linagliptin 5 mg and placebo for 24 weeks, respectively. Blood pressure, lipid profile, liver enzymes, fasting plasma glucose (FPG), and urine albumin-creatinine ratio ( | PMC9975829 |
Introduction | T2D, diabetic nephropathy, microalbuminuria, Diabetes | METABOLIC DISEASES, DIABETIC NEPHROPATHY, DIABETES | Diabetes is one of the most common metabolic diseases, and its prevalence is increasing in adults, especially in developing countries such as IranTherefore, considering the limited and contradictory clinical evidence reporting the therapeutic effects of DPP-4 inhibitors, especially linagliptin, on diabetic nephropathy in patients with T2D, this study aimed to investigate the effect of linagliptin on microalbuminuria as a key step in preventing the progression of diabetic nephropathy in patients with T2D. | PMC9975829 |
Methods | PMC9975829 | |||
Design of the study and participants | T2D, microalbuminuria, nephropathy | MYOCARDIAL INFARCTION, STROKE, COMPLICATIONS, NEPHROPATHY, TRANSIENT ISCHEMIC ATTACK | This double-blind, randomized, placebo-controlled clinical trial was performed on 92 patients with T2D and nephropathy that referred to the Isfahan Endocrine and Metabolism Research Center from November 2019 to April 2021.Inclusion criteria consisted of T2D patients age ≥ 18 years, and microalbuminuria (urine albuminFurthermore, patients who were taking short-acting insulins, rosiglitazone, pioglitazone, GLP-1 receptor analogues, sodium glucose co-transporter 2 inhibitors or anti-obesity drugs within three months before the beginning of the study, those with a history of myocardial infarction, stroke, or transient ischemic attack within 6 months of the beginning of the study, patients who had non-diabetic renal failure or urinary tract infection, or those who had received a kidney transplant were not included in the study. They were excluded the study, in the case of not cooperating, not attending in the follow-up sessions, or showing drug-induced complications. | PMC9975829 |
The process of implementing interventions and measuring research variables | T2D, high-density lipoprotein, hypoglycemic, ’ eating habits, Diabetes, TG, diabetes | DIABETES, COMPLICATIONS, DIABETES | The study was approved by the Isfahan University of Medical Sciences ethics committee (Approval no. IR.MUI.MED.REC.1397.230), and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients. The study protocol was registered at irct.ir as IRCT20171030037093N11 (Ninety two eligible patients were selected using convenience sampling method. Then, these patients were divided into two groups using random allocation software. At the beginning of the study, patients’ demographic and clinical information including sex, age, BMI, waist circumference (WC), systolic blood pressure (SBP), diastolic blood pressure (DBP), comorbidities, duration of T2D, history of drug use (lipid-lowering drugs, hypoglycemic drugs, and antihypertensive drugs), biochemical parameters including urine creatinine (Urine Cr), urine albumin (Urine Alb), UACR, Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), serum creatinine and glomerular filtration rate (GFR) by MDRD formula, lipid profile including triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol, and liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) were recorded.For all patients, a routine diabetes treatment was prescribed according to the standard protocol of American Diabetes association (ADA) statement. In addition, 5 mg of linagliptin was administered to patients in the intervention group for 24 weeks while patients in the control group received placebo for 24 weeks.It should be mentioned that in order to comply with the double-blind condition, linagliptin and placebo which had been already prepared by Alhavi Pharmaceutical Company, located in Tehran, Iran, in the same shape, size, and color. Starch had been used to make placebo tablets. The prepared drugs had been coded, and provided to the researcher. Therefore, the researcher, patients, the information evaluator, and the statistical analyst had no knowledge of the type of the intervention performed in the two groups.Furthermore, all patients were requested to follow the healthy dietary patterns and proper physical activity in the treatment process to control these factors as much as possible and prevent the disruptive effect of patients’ eating habits and physical activity on the results of the study.Patients were evaluated in terms of the complications of the medication two weeks after the beginning of the intervention and then every 4 weeks. In addition, patients’ anthropometric, blood pressure, and biochemical factors were assessed 12 weeks and 24 weeks after the intervention. To perform accurate measurements and evaluations, data collection was performed by a single specialist technician, and all biochemical tests were performed only in the Laboratory of Isfahan Endocrine and Metabolism Research Center. | PMC9975829 |
Statistical analysis | The collected data were analyzed by SPSS software (ver.26) (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp.). Quantitative and qualitative variables were reported as means ± standard deviation (SD) and number (percentage), respectively. Kolmogorov–Smirnov test and Q-Q diagram were used to check the normality of data distribution. Basic quantitative and qualitative variables of study participants were compared two groups using independent samples | PMC9975829 | ||
Ethical approval | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the ethics Committee of the Isfahan University of Medical Sciences (Approved code: IR.MUI.MED.REC.1397.230) and its clinical trial code is recorded (IRCT20171030037093N11). | PMC9975829 | ||
Informed consent | Written informed consent was obtained from all patients for precipitation and registration. | PMC9975829 | ||
Discussion | hepatic cholestasis, diabetic nephropathy, diabetic, microalbuminuria, diabetic kidney diseases | DIABETIC NEPHROPATHY | Since there were several studies on the effectiveness or ineffectiveness of linagliptin on albumin excretion in urineOn the other hand, FPG and HbA1C had a significant decrease in both linagliptin and control groups. A study, conducted by Ito et al. indicated that the mean level of HbA1C in the two groups with and without receiving linagliptin was not significantly differentThe results of the present study revealed that triglyceride were significantly reduced in each group over 24 weeks from the beginning of the intervention, however the decreases were not significantly different between two groups. Howevere, the results of Monami et al. study showed that DPP-4 inhibitors had a reducing effect on triglyceridesIn the present study, cholesterol change was not significantly different between the two groups.In addition to our study, among liver enzymes, ALP was significantly higher in the linagliptin group as compared with the control group 12 weeks after the intervention. In this respect, the results of the repeated measures ANOVA indicated the significant effect of the intervention. It is important to note that the increase in ALP was not significant between two groups 24 weeks after the beginning of the intervention. The reason for the transient increase in alkaline phosphatase in the twelfth week of the study in the linagliptin group may be due to the effect of linagliptin on bone metabolism or indicate hepatic cholestasis. As we had not measured GGT (Gama-Glutamyl Transferase), we cannot determine the alkaline phosphataseʼ origin. However, the effects of DPP-4 inhibitors, including linagliptin, on bone metabolism are still unknown. One study by Kanda et al. showed a protective effect of linagliptin on the bones of diabetic ratsThe results of the evaluation of renal function factors as well as microalbuminuria also showed that although there was a significant decrease in GFR and a significant increase in Cr in the linagliptin group, the effect of the intervention and the interactive effect of time and intervention were still not significant. Moreover the rate of decrease in GFR and increase in creatinine was not more than 30% and the effect of the intervention was not significant, it is necessary to examine this finding with more participants and longer follow-up period. In this regard, Nishida et al. conducted a study to investigate the effects of DPP-4 inhibition on diabetic patients and noted a negative brief effect on creatinineIt should be noted that this study was also associated with some limitations and strengths. The investigation area of the present study, which was the evaluation of the effect of linagliptin on microalbuminuria in patients with diabetic nephropathy, can be considered novel as few studies have been performed with this aim. The mentioned point can be regarded as one of the strong points of this study. However, this study was only been performed on patients with diabetic nephropathy (microalbuminuria with mild reduced GFR), so it is imprecise whether the findings can be generalized to patients with more advanced diabetic kidney diseases. In addition, the small number of participants and the short follow-up period can be regarded as another limitation of this study. | PMC9975829 |
Acknowledgements | The authors would like to express their special gratitude to Alhavi Pharmaceutical Company for its continued support and cooperation in the present study by providing the linagliptin and placebo tablets. The address of Alhavi Pharmaceutical Company is 12th Kilometer of Karaj Makhsos road, Tehran, IRAN. | PMC9975829 | ||
Author contributions | M.K. and J.A. designed the study, interpreted the data and wrote the manuscript. M.A., and F.M. designed the study and interpreted the data. A.F. contributed to the statistical analysis and interpretation of data. A.A. contributed to conducting the research, interpreting the data and reviewed the manuscript. All authors have read and agreed to the publication of this paper. | PMC9975829 | ||
Funding | This work supported by deputy research and technology of Isfahan University of Medical Sciences (Grant# 397535). | PMC9975829 | ||
Data availability | The data that support the findings of this study are available on request from the corresponding author, A. A. The data are not publicly available due to their containing information that could compromise the privacy of research participants. | PMC9975829 | ||
Competing interests | The authors declare no competing interests. | PMC9975829 | ||
References | PMC9975829 | |||
1. Introduction | respiratory illness, inflammation, reinfection, infections | INFLAMMATION, INFECTIONS, COVID-19 INFECTION, CORONAVIRUS, MAY, REINFECTION, CRITICAL ILLNESS, REGRESSION, BLOOD, INFLAMMATORY DISEASE | COVID-19 infection and vaccination offer disparate levels of defense against reinfection and breakthrough infection. This study was designed to examine the effects of curcumin supplementation, specifically HydroCurc (CURC), versus placebo (CON) on circulating inflammatory biomarkers in adults who had previously been diagnosed with COVID-19 and subsequently received a primary series of monovalent vaccine doses. This study was conducted between June 2021 and May 2022. Participants were randomized to receive CURC (500 mg) or CON capsules twice daily for four weeks. Blood sampling was completed at baseline and week-4 and analyzed for biomarkers. Linear regression was utilized to examine the between-group differences in post-trial inflammatory biomarker levels, adjusting for baseline and covariates including age, sex, race/ethnicity, and interval between COVID-19 diagnosis and trial enrollment. The sample (SARS-CoV-2 is a positive-sense single-stranded RNA coronavirus which causes the respiratory illness COVID-19, first identified in December 2019 in Wuhan, China. Since 2019, over 750 million individuals worldwide have been diagnosed with COVID-19, with infections ranging from asymptomatic to critical illness [Importantly, the presence of elevated inflammation has been demonstrated to impact COVID-19 outcomes and prolonged inflammation and viral persistence have been demonstrated in convalescent patients [In this context, curcumin, a polyphenolic compound derived from the rhizomes of turmeric (However, the attempts to translate findings from mechanistic studies of curcumin in clinical trials examining its effects on inflammation in healthy individuals and those with inflammatory diseases have yielded inconsistent results [Given the immunomodulatory mechanisms of curcumin and the rise in breakthrough infections coinciding with the emergence SARS-CoV-2 variants, curcumin may offer anti-inflammatory and prophylactic benefits in healthy individuals with a history of prior COVID-19 infection who received the COVID-19 vaccine. In this context, the research aimed to contribute to the literature related to curcumin in a novel manner, and to examine the effects of four weeks of curcumin supplementation on circulating mediators of inflammation in healthy adults who previously tested positive for COVID-19 and subsequently received a primary series of monovalent vaccine doses, compared to a placebo control. Further, we utilized a novel formulation of curcumin, specifically HydroCurc, which has been shown to significantly increase the absorption of curcumin compared to a standard form [ | PMC10096702 |
2. Materials and Methods | PMC10096702 | |||
2.1. Participants | word of mouth | MAY, COVID-19 INFECTION | This study was conducted between June 2021 and May 2022. Healthy adults between the ages of 18 and 65 years, who had previously tested positive for COVID-19 as per a positive RT-PCR test, and had subsequently received the full primary series of monovalent vaccine doses were recruited via online advertisements, social media, existing list-serves, and word of mouth to participate in this study. Participants were eligible if they previously experienced asymptomatic, mild, or moderate COVID-19 infection, as defined by the National Institutes of Health (NIH) COVID-19 Treatment Guidelines, and subsequently received the full primary series of a COVID-19 vaccine at least 3 months prior to enrollment [ | PMC10096702 |
2.2. Study Protocol | coin toss | Initially this study was designed to recruit participants who has recently tested positive for COVID-19 (within the prior 10–15 days) and were unvaccinated. However, in December of 2020, the Pfizer-BioNTech COVID-19 vaccine was made available under emergency use authorization by the US Food and Drug Administration (FDA) [This study followed a randomized placebo-controlled parallel arm trial design. Participants were randomized by coin toss to receive the active ingredient dietary supplement or placebo for four weeks. Randomization was carried out by a blinded research team member who was not involved in data collection. Participants interested in the study were initially screened for eligibility via an online survey. Those who met inclusion criteria per the online screener were interviewed by phone to confirm eligibility. Eligible participants were scheduled to visit the test site (ISTB8 Phoenix Biomedical Collaborative Building; Phoenix, AZ, USA). The study participants visited the test site twice during the study period, at baseline and week 4. Study measures conducted during the baseline visit were repeated at week 4. During study visits, participants completed a standard health history questionnaire and were led through a multiple pass 24-h dietary recall by trained study staff. Study staff blinded to participant group assignment analyzed data from diet recalls using The Food Processor | PMC10096702 | |
2.3. Dietary Supplementation | Participants assigned to the active treatment group (CURC) ingested 500 mg HydroCurc | PMC10096702 | ||
2.4. Analysis of Blood Samples | BLOOD, ADHESION | At baseline and week 4, participant blood samples were collected from the antecubital vein via standard phlebotomy techniques into appropriate vacutainers. Blood was collected in 4 mL dipotassium EDTA tubes and 8.5 mL serum separator tubes. After centrifugation, a portion of collected serum was aliquoted and stored at −80 °C until analyses of cytokines and adhesion molecules. Whole blood was transported and analyzed by Sonora Quest Laboratories (Arizona) for complete blood count with differentials, which was utilized for computation of neutrophil/lymphocyte ratios (NLR). Serum was also analyzed for high sensitivity C-reactive protein (hsCRP) and ferritin by Sonora Quest Laboratories. Soluble P-selectin (sP-selectin) and soluble intercellular adhesion molecule 1 (sICAM-1) levels in serum samples were analyzed via ELISA methods (Invitrogen, Thermo Fisher Scientific, Waltham, MA, USA). Circulating serum cytokines and chemokines were analyzed via human-focused 15-plex discovery assay (Eve Technologies Corporation, Calgary, Canada). This biomarker panel provided quantitation of IL-6, IL1-β, IL-1receptor agonist (Ra), IL-2, IL-4, IL-5, IL-8, IL-10, IL-12p40, IL-12p70, IL-13, MCP-1, IFN-γ, granulocyte-macrophage colony-stimulating factor (GM-CSF), and TNF-α. | PMC10096702 | |
2.5. Statistical Analysis | REGRESSION | Demographic and baseline participant characteristic data are displayed as the mean ± SD or number (%). We aimed to investigate the effects of curcumin supplementation for four weeks on a panel of circulating cytokines compared to the placebo. Initially, we examined histograms of cytokine concentrations and applied log transformations to reduce skewness prior to further analyses. Additionally, cytokine concentrations below the limit of assay detection were replaced with the lowest detected value of the marker divided by 5. A series of linear regression models was used to examine the between-group differences in post-trial biomarker concentrations, controlling for baseline and covariates including age, sex, race/ethnicity, and interval between COVID-19 diagnosis and study enrollment. A nominal | PMC10096702 | |
3. Results | PMC10096702 | |||
3.1. Study Participants and Intervention Compliance | gastrointestinal distress, light-headedness | We received 288 respondents to the initial screening survey. Of the participants screened for eligibility, a total of 36 participants met inclusion criteria and were enrolled in the trial. One participant randomized to the CURC group withdrew prior to the study initiation due to scheduling conflicts, and one participant withdrew prior to blood sampling due to fear of phlebotomy. All participants randomized to the CON group received the allocated treatment. However, three participants in the CON group were lost to follow-up. One participant withdrew due to adverse reporting of gastrointestinal distress and light-headedness, one withdrew due to personal conflicts unrelated to the study, and one participant withdrew for undisclosed reasons. Therefore, 31 participants ( | PMC10096702 | |
3.2. Dietary Intakes | Dietary analysis was completed based on structured 24 h dietary recalls performed by a trained study staff member following the multiple pass method at baseline and week 4. Analysis of diet records obtained throughout the trial did not reveal significant differences between the CURC and CON groups based on the change (post-pre) in dietary intakes of energy, carbohydrates, proteins, fats, saturated fatty acids, sugar, calcium, iron, sodium, or potassium ( | PMC10096702 | ||
3.3. Inflammatory Biomarkers | REGRESSION | We aimed to examine the between group differences in post-trial inflammatory biomarker concentrations adjusting for baseline levels of the outcome and covariates. The results of the linear regression analyses revealed that assignment to the CURC group was associated with significantly lower mean post-trial concentrations of the inflammatory biomarkers, IL-6 ( | PMC10096702 | |
4. Discussion | pneumonia, inflammation, ARDS, infection, cold-like | PNEUMONIA, INFLAMMATION, DISEASE, INFECTION, ARDS, ACUTE RESPIRATORY DISTRESS SYNDROME, INFLAMMATORY RESPONSE | In this double-blinded randomized placebo-controlled parallel arm trial, we demonstrated the anti-inflammatory effects of ingesting 500 mg of HydroCurc twice daily on circulating inflammatory biomarkers in adults who had previously tested positive for COVID-19 and were subsequently vaccinated, compared to placebo. Specifically, after four weeks of supplementation, the CURC group had significantly lower mean concentrations of circulating IL-6 (Curcumin ((1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione) is the primary bioactive polyphenolic compound derived from turmeric, which has been used in the context of traditional Asian medicine for its anti-inflammatory, anti-viral, and anti-oxidative properties [In this present study, key indicators of inflammation (IL-6 and MCP-1) rose significantly in the control group over the course of the 4-week study in comparison to the curcumin supplemented group. These data suggest that curcumin supplementation may help to manage inflammation and promote resilience. MCP-1 is a chemokine produced in response to inflammatory stimuli which promotes monocyte chemotaxis and modulates leukocyte trafficking, further propagating the inflammatory response [Curcumin has been demonstrated to suppress the expression of inflammatory cytokines, including IL-6 and MCP-1, from lung tissue in a murine model of virus-induced acute respiratory distress syndrome (ARDS), potentially through a reduction in NF-κB activation [Importantly, there is promising evidence from clinical trials to support the anti-inflammatory role of curcumin in adults with varying levels of health. A recent meta-analysis examining the effects of curcumin on circulating IL-6 in various adult populations from nine clinical trials, found that supplementation significantly reduced IL-6 concentrations [The present study is not without limitations, such as the small sample size (COVID-19 has placed significant economic and societal burdens on the global population. Upon infection with SARS-CoV-2, the presentation of COVID-19 symptoms spans mild cold-like manifestations to pneumonia and severe acute respiratory distress syndrome, with the severity of disease being associated with the dysregulated release of cytokines [ | PMC10096702 |
5. Conclusions | inflammation, COVID-19 infection | INFLAMMATION, COVID-19 INFECTION | This study investigated the anti-inflammatory and prophylactic effects of curcumin in individuals who had recovered from COVID-19 infection and were subsequently vaccinated. We demonstrated that curcumin supplementation was associated with significantly lower levels of the proinflammatory cytokines IL-6 and MCP-1, which increased in the control group during the four-week trial period. These findings indicate that curcumin supplementation may help to control inflammation and support resilience. | PMC10096702 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10096702 | ||
Author Contributions | C.S.J., Y.C., L.L. and S.N.F., conceptualization; C.S.J., Y.C., L.L. and S.N.F., methodology; C.S.J. and S.N.F., project administration; C.S.J., Y.C., L.L. and S.N.F., supervision; S.N.F., investigation; L.L. and S.N.F., formal analysis; S.N.F. and C.S.J., writing—original draft preparation; C.S.J., Y.C., L.L. and S.N.F., writing—review and editing; C.S.J., Y.C. and L.L., funding acquisition. All authors have read and agreed to the published version of the manuscript. | PMC10096702 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of Arizona State University (STUDY 00012406). | PMC10096702 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10096702 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10096702 | ||
Conflicts of Interest | The authors declare no conflict of interest. The sponsors had no role in the execution, interpretation, or writing of the study. | PMC10096702 | ||
Abbreviations | tumor necrosis, COPD | TUMOR NECROSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, ADHESION, DISEASE | CURC: 500 mg HydroCurc twice daily; CON, placebo; hsCRP, high sensitivity C-reactive protein; GM-CSF, granulocyte-macrophage colony-stimulating factor; sICAM-1, soluble intercellular adhesion molecule 1; IFN, interferon; IL, interleukin; MCP-1, monocyte chemoattractant protein-1; NF-κB, nuclear factor-kappa B; N/L, neutrophil/lymphocyte ratios; sP-selectin, soluble P-selectin; TNF, tumor necrosis factor; TLR-4, Toll like receptor 4; BMI, body mass index; NIH, National Institutes of Health, CDC, Centers for Disease Control and Prevention; FDA, US Food and Drug Administration; Cmax, peak plasma concentration; ACE2, angiotensin-converting enzyme 2; MAPK, mitogen-activated protein kinase; STAT3, signal transducer and activator of transcription 3; NLRP3, NLR family pyrin domain containing 3; COX-2, cyclooxygenase 2; COPD, chronic obstructive pulmonary disease. | PMC10096702 |
Subject terms | mentalizing deficits, deficits in mentalizing in, various deficits, psychosis, cognitive deficits, psychotic symptoms, Schizophrenia, schizophrenia, reduced mentalizing performance | SYNDROME, POSITIVE | Schizophrenia is associated with various deficits in social cognition that remain relatively unaltered by antipsychotic treatment. While faulty glutamate signaling has been associated with general cognitive deficits as well as negative symptoms of schizophrenia, no direct link between manipulation of glutamate signaling and deficits in mentalizing has been demonstrated thus far. Here, we experimentally investigated whether ketamine, an uncompetitive N-methyl-D-aspartate receptor antagonist known to induce psychotomimetic effects, influences mentalizing and its neural correlates. In a randomized, placebo-controlled between-subjects experiment, we intravenously administered ketamine or placebo to healthy participants performing a video-based social cognition task during functional magnetic resonance imaging. Psychotomimetic effects of ketamine were assessed using the Positive and Negative Syndrome Scale. Compared to placebo, ketamine led to significantly more psychotic symptoms and reduced mentalizing performance (more “no mentalizing” errors). Ketamine also influenced blood oxygen level dependent (BOLD) response during mentalizing compared to placebo. Specifically, ketamine increased BOLD in right posterior superior temporal sulcus (pSTS) and increased connectivity between pSTS and anterior precuneus. These increases may reflect a dysfunctional shift of attention induced by ketamine that leads to mentalizing deficits. Our findings show that a psychotomimetic dose of ketamine impairs mentalizing and influences its neural correlates, a result compatible with the notion that deficient glutamate signaling may contribute to deficits in mentalizing in schizophrenia. The results also support efforts to seek novel psychopharmacological treatments for psychosis and schizophrenia targeting glutamatergic transmission.Open Access funding enabled and organized by Projekt DEAL. | PMC10567921 |
Introduction | deficits in social cognition, psychosis, schizophrenia, cognitive domain | People with schizophrenia frequently show deficits in social cognition, a cognitive domain comprising multiple processes including social cue perception, mentalizing, regulation of emotion and experience sharingWhile in some instances social cognition or mentalizing were shown to improve upon treatment with atypical antipsychoticsSince discovery of its psychotomimetic qualities, subanesthetic ketamine has been used as a model for psychosis in humans and rodentsThe aim of this study was to find out whether manipulating NMDA-receptor activation via ketamine would influence mentalizing and its neural correlates in healthy volunteers. We used a modified version of the Movies for the Assessment of Social Cognition (MASC) task by Dziobek and colleagues to assess the level of mentalizing (normal, over-, under- or no mentalizing) | PMC10567921 | |
Methods | PMC10567921 | |||
Ethical approval | The randomized and placebo-controlled study was performed in accordance with the declaration of Helsinki after being approved by the local ethics committee at the Department of Psychology at the University of Bonn, Germany. Data was collected in an MRI facility at the University Hospital of Bonn between June 2019 and September 2020. | PMC10567921 | ||
General procedure | ADVERSE EVENTS, ADVERSE EFFECTS, SYNDROME, POSITIVE | On the day of the experiment, participants were required to arrive with an empty stomach, having fasted food at least 6 h and clear fluids 2 h prior to examination. Participants gave written informed consent and received written instructions. After medical examination by an anesthesiologist, an intravenous access was applied to one arm and participants were led into the MRI scanner. After participants were placed inside the MRI scanner and preparations were complete, the infusion was initialized. The anesthesiologist ensured there were no adverse events and participants were able to familiarize themselves with the substance prior to scanning to avoid anxiety-related adverse effects. The experimental task and MRI data acquisition were then initiated under continuous heart rate and oxygen level monitoring throughout the infusion. After completion of MRI data acquisition, the infusion was stopped, and participants completed the Positive and Negative Syndrome Scale (PANSS) interview with a trained blinded rater. | PMC10567921 | |
Drug administration | A subanesthetic dose of ketamine was delivered via a Graseby 3500 intravenous infusion pump controlled by the STANPUMP software (Steven Shafer, M.D., Anesthesiology Service, PAVAMC 3801 Miranda Ave., Palo Alto, USA). Target plasma levels were 100 ng/ml with an initial bolus administered as a 2 mg/ml solution. The plasma level of 100ng/ml was chosen in accordance with a study of Krystal et al. | PMC10567921 | ||
Experimental task | We employed a modified version of the MASC task, which assesses mentalizing performance using a set of videos depicting subsequent stages of social interactions between four human agents. The four agents spend an evening together, take part in various activities and interact in friendly, hostile, or romantic ways. The movie is interrupted at key timepoints by four-alternative-forced-choice questions about the currently ongoing social situation (e.g., “what is Michael feeling?”). The four response options represent four possible levels of mentalizing: overmentalizing, “normal” mentalizing, undermentalizing or no mentalizing. The “normal” mentalizing response is the answer that most healthy participants would give and is considered the “correct” answer to the question. Our version of the MASC task was structured as follows (Fig. Depiction of one trial of the experimental task, a modified version of the MASC experiment by Dziobek et al. | PMC10567921 | ||
PANSS | schizophrenia | SYNDROME, POSITIVE | The Positive and Negative Syndrome Scale (PANSS) is a semi-standardized medical interview used for measuring symptom severity in schizophrenia. Symptoms are by default subdivided into positive symptoms, negative symptoms and general symptoms | PMC10567921 |
fMRI image acquisition and data analysis | Images were acquired using a 3T Siemens TrioTim MRI scanner (Siemens, Erlangen, Germany). Because participants wore pneumatic headphones, we used a 12- instead of a 32-channel headcoil as the latter was too small to fit participants’ heads with headphones. Using a 12-channel headcoil does not significantly decrease blood-oxygen-level-dependent (BOLD) signal in cortical areasFunctional images were acquired using a T2*-weighted echo-planar imaging sequence (echo time (TE) = 30 ms, repetition time (TR) = 2500 ms, flip angle = 90°, voxel-size = 2 × 2 × 3 mm, slice thickness = 3mm, field of view (FOV) = 192 mm, 37 slices). For purposes of normalization, a T1-weighted structural scan was acquired (TE = 2.54 ms, TR = 1660 ms, inversion time = 800 ms, slice thickness = 0.8 mm, matrix size = 320 × 320, FOV = 256 mm, flip angle = 9°, voxel-size = 0.8 × 0.8 × 0.8 mm, 208 sagittal slices).First, fMRI images were checked manually for abnormalities upon which three participants had to be excluded due to artifacts in functional images. Functional EPI images were analyzed using SPM12 (Wellcome Center for Neuroimaging, London, UK, | PMC10567921 | ||
fMRI data analysis | REGRESSION | For each participant, a fixed-effects general linear model (GLM) was fitted to the preprocessed BOLD signal data using SPM12. The GLM contained separate sets of four regressors for the social and physical trials, modeling the following trial parts: presentation of the question before and after the video, presentation of the video, response, and confidence rating. The model further included six movement regressors representing estimates of rotation and translation created during the realignment step of data preprocessing, and a constant term. While the task was not designed to separate neural activation evoked during the subsequent trial parts, modeling these trial parts separately increased the flexibility of the GLM at small costs on degrees of freedom. The response phase was modelled from offset of the second question presentation to participants’ answer to the mentalizing question, and the confidence rating phase spanned the time between answer to the mentalizing question and locking of the confidence rating. Regression coefficients (parameter estimates) for these regressors were estimated for each voxel of each participant’s brain. Linear contrasts were applied to the individual parameter estimates of the response to the experimental conditions in order to contrast each of these four trial parts of the social and physical trials.To determine the effect of ketamine on BOLD signal during mentalizing, we first verified that the social cognition task evoked activation in brain regions known to be involved in social cognition under placebo. To this end, we constructed a second-level (random effects) model in SPM that allowed us to contrast neural correlates of social vs non-social cognition under placebo and ketamine in the four trial parts (see Fig. Parameter estimates from a region of interest (ROI) in the right pSTS region, identified in one of the t-tests (see Results), were exported using MarsBaR in SPM12Effects of ketamine on functional connectivity between the pSTS ROI and other areas of the brain were assessed using a generalized psychophysiological interactions (gPPI) analysis with the CONN-toolbox in SPM 12Contrast images between functional connectivity during the social and physical question part of the trial (SOC > PHY) were then separately assessed in the participants of the placebo and the ketamine group using random effects one-sample t-tests in SPM 12; the effect of ketamine was assessed by comparing these contrast maps across groups using an independent samples t-test. All results of the fMRI analyses were considered significant if they exceeded the threshold of p < 0.05 after family-wise error correction for multiple comparisons at the cluster level across all the voxels of the brain, based on an uncorrected threshold (= cluster-forming threshold) of p < 0.001 at the voxel level. These results are indicated as p | PMC10567921 | |
Analysis of the behavioural data | Behavioural data were analyzed using SPSS 27 (IBM Corp., Armonk, USA). Effects of substance on PANSS were tested using independent samples | PMC10567921 | ||
Results | PMC10567921 | |||
Effects of ketamine on symptoms of schizophrenia | Participants under ketamine showed significantly more schizophrenia-related symptoms than controls in four of the five factors used to assess the PANSS data: positive symptoms ( | PMC10567921 | ||
Effects of ketamine on mentalizing | Participants made more errors in the social than in the physical trials of the modified MASC task (Effects of ketamine on mentalizing: participants under ketamine gave more “no mentalizing” answers in our movie-based theory-of-mind task (modified MASC) than controls; | PMC10567921 | ||
Neural correlates of mentalizing under ketamine | We expected social trials to evoke BOLD signal increases in social brain regions when compared to physical trials (control). This manipulation check was performed on the data of the placebo participant group creating a second-level model, using the SOC > PHY contrast images for the question part of the trial. Results (Fig. Neural correlates of social cognition and effects of ketamine during the modified MASC task. Threshold at p(FWE-cluster level) = 0.05, based on a voxelwise uncorrected threshold of p < 0.001. (We proceeded to evaluate effects of ketamine on social cognition during the MASC by comparing, for each of the four trial parts, the social with the physical trials (SOC > PHY) between groups. We found a significant increase in BOLD signal in the ketamine group during presentation of the questions in a cluster located in the right posterior superior temporal sulcus region [pSTS; x = 45, y = − 58, z = 17, Clusters of voxels that exhibited increased functional connectivity with the right pSTS in the placebo group during the question phase of the social compared to the physical trials were found (see Fig. Functional connectivity during social cognition and effects of ketamine. Threshold at p(FWE-cluster level) = 0.05, based on a voxelwise uncorrected threshold of p < 0.001. ( | PMC10567921 | ||
Discussion | mentalizing deficits, schizophrenia and deficits in social cognition, schizophrenia, with reduced neurocognitive functioning, social cognitive dysfunction | DISORDER, MRS, CORTEX | The present study indicates that a dose of ketamine inducing positive and negative symptoms associated with schizophrenia impairs mentalizing during the observation of social interactions and increases neural activity in right pSTS as well as connectivity between right pSTS and anterior precuneus during this task. These findings suggest that intravenous subanesthetic ketamine impairs social cognition and affects its neural correlates, supporting a link between a proposed psychopathological mechanism in schizophrenia and deficits in social cognition associated with that disorder. However, it should be mentioned that these deficits were not limited to social cognition, as participants were also presenting with reduced neurocognitive functioning in the control-condition.The MASC task used here allows to characterize mentalizing deficits specifically by differentiating over- from undermentalizingWhile no study has investigated the causal effects of acute blockade of NMDA-receptors on mentalizing in healthy volunteers, several correlational studies have linked high glutamate concentration, or high glutamate to GABA ratios, with social cognitive dysfunction. For example, glutamate concentration in dorsolateral prefrontal cortex of healthy participants measured with magnetic resonance spectroscopy (MRS) was negatively correlated with perspective taking scores in a task designed to assess empathy in people with schizophrenia and ASDOur results support this hypothesis by demonstrating causal alteration of mentalizing in participants undergoing NMDA-receptor blockade by ketamine. We note that we cannot make conclusions specific to mentalizing, as performance in the non-social condition of our task was also reduced under ketamine. The lower performance observed in both the control and social cognition conditions within the ketamine group can possibly be partly attributed to the dissociative effects of ketamineAt the neural level, we found activation in left pSTS, cuneus, middle occipital gyrus, precuneus and right pSTS during the question phase of the MASC in the placebo group during our manipulation check. Some of these regions (pSTS and precuneus) are part of the mentalizing network and are thus typical of activations expected in a social cognition taskSeveral regions showed changes in functional connectivity with the seed cluster under placebo during the question phase (social > physical): connectivity with STG and posterior cingulate increased, possibly reflecting reasoning about mental states of others and oneselfCoactivation of pSTS and precuneus in healthy participants has been observed during naturalistic social tasks involving reasoning about emotional and mental states of others | PMC10567921 |
Limitations | schizophrenia, neurocognitive and social cognitive deficits, psychosis | DISORDERS, MRS | Limitations in our study concern the behavioral task, the ketamine-model for psychosis and whether changes evoked by ketamine reflect changes in glutamate-signalling. In our task, participants relied both on visual and acoustic features of the video clips to perform the social task, while solely visual information mattered in the physical condition, which yields asymmetry between the conditions.A limitation of the ketamine-model for psychosis comes from the smaller impact on PANSS levels of ketamine (mean of 40 in our and similar studiesFinally, since we did not measure glutamate levels after administering ketamine, conclusions about whether the fMRI results were caused by changes in glutamate transmission cannot be drawn. Even though most MRS studies showed that ketamine causes changes in glutamatergic transmission in anterior cingulate, not all studies were able to replicate these effectsTaken together, our findings show that people who received ketamine were exhibiting neurocognitive and social cognitive deficits in a naturalistic mentalizing-task. They mentalized less and demonstrated changes in BOLD-activity and task-related connectivity in right pSTS and precuneus, hinting to how glutamatergic neurotransmission might be tied to emergence of these deficits in disorders like schizophrenia. | PMC10567921 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-44443-6. | PMC10567921 | ||
Acknowledgements | The authors would like to thank Laura Augsburg and Lisanne vom Schemm for assistance in data collection, Paul Jung for assistance in experiment programming and Isabel Dziobek for kindly allowing use and adaptation of the MASC task. | PMC10567921 | ||
Author contributions | S.W.: conceptualization, resources, data curation, software, formal analysis, validation, investigation, visualization, methodology, writing—original draft, project administration, writing—review and editing; J.S.: conceptualization, resources, data curation, software, formal analysis, supervision, validation, visualization, methodology, writing—original draft, writing—review and editing; M.L.: conceptualization, data curation, software, investigation, methodology, writing—original draft, writing—review and editing. C.N., A.D.: investigation, project administration, methodology, resources, investigation, writing—review and editing; U.E., R.H., A.P.: conceptualization, funding acquisition, resources, writing—review and editing. | PMC10567921 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. SW was partially funded by BMBF project ESPRIT (EUDRA-CT: 2014-003076-22). Open access funding provided by University of Bonn. | PMC10567921 | ||
Competing interests | The authors declare no competing interests. | PMC10567921 | ||
References | PMC10567921 | |||
1. Introduction | weight gain, depression, Sedentary behavior | PRETERM BIRTH, GESTATIONAL DIABETES MELLITUS, SECONDARY, DELIVERY COMPLICATION, PREECLAMPSIA | Pregnancy is often associated with poor sleep and high sedentary time (SED). We investigated the effect of physical activity (PA) interventions on sleep and SED in pregnant women. A secondary analysis of a randomized controlled trial (Pregnant women benefit from physical activity (PA) during pregnancy, including a decreased risk of excessive gestational weight gain, preterm birth, gestational diabetes mellitus, preeclampsia, delivery complications, and postpartum depression [Sedentary behavior is considered any physical behavior that does not significantly raise energy expenditure above that of resting (less than a 1.5 metabolic equivalence of the task), such as sleeping, sitting, lying down, watching television, and other screen-based activities [Several PA interventions during pregnancy have focused on increasing moderate-to-vigorous-intensity PA (MVPA) and PA in general and evaluating the health effects of these interventions. However, few have focused on exploring the effect of PA interventions on sleep quantity and quality and SED during pregnancy [ | PMC10094525 |
2. Methods | PMC10094525 | |||
2.1. Ethics and Public Involvement | The FitMum study was approved by the Danish National Committee on Health Research Ethics (#H-18011067) and the Danish Data Protection Agency (#P-2019-512). The study adheres to the principles of the Helsinki declaration and is registered at | PMC10094525 | ||
2.2. Setting | MAY | This study was conducted at the Department of Gynaecology and Obstetrics at the public hospital Copenhagen University Hospital—North Zealand, Hillerød. Participation in the FitMum RCT was free of charge. The first participant was included in October 2018, and the last participant gave birth in May 2021. | PMC10094525 | |
2.3. Participants and Study Design | intrauterine pregnancy | Two hundred twenty healthy pregnant women were included. Inclusion criteria were obtaining written informed consent, being 18 years or older, having a maximum gestational age (GA) of 15 weeks, having an ultrasonic-confirmed viable intrauterine pregnancy, having a body mass index of 18.5–45 kg/m | PMC10094525 | |
2.4. Interventions | The aims and primary results of the FitMum study have been published elsewhere [ | PMC10094525 | ||
2.5. Outcomes | PMC10094525 | |||
2.5.1. Sleep Quantity and Quality by Pittsburgh Sleep Quality Index | The Danish version of the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire [ | PMC10094525 | ||
2.5.2. Sedentary Time by the Pregnancy Physical Activity Questionnaire | The Pregnancy Physical Activity Questionnaire (PPAQ) was designed and developed to determine PA intensity and duration during pregnancy [ | PMC10094525 | ||
2.5.3. Sleep and Sedentary Time by the Activity Tracker | The activity tracker data management and measurement details are published elsewhere [Moreover, the activity tracker shows PA daily values in a detailed log (Epoch log). From the Epoch log, a categorization of time is sorted into sedentary, active, or highly active by algorithms in the activity tracker. Sedentary is defined as little to no activity monitored; accordingly, minimal movement, sitting, resting, and sleeping are considered sedentary behavior [ | PMC10094525 | ||
2.6. Statistical Analysis | For the PSQI and PPAQ outcomes, a constrained linear mixed model was fitted with the observation times as a factor [ | PMC10094525 | ||
3. Results | PMC10094525 | |||
3.1. Participant Characteristics | 219 women were randomised to CON ( | PMC10094525 | ||
3.2. Sleep Quantity and Quality by the Pittsburgh Sleep Quality Index | PSQI was completed by 219 (100%), 180 (82%), and 165 (75%) participants at baseline, GA week 28, and GA week 34, respectively. The mean global PSQI score (6.4 ± 1.9) was above 5 for all three groups at baseline. When comparing the two intervention groups with CON, EXE scored lower (i.e., lower means better) in the global PSQI score at GA week 28 (−0.8 [−2; −0.1], Also, MOT scored lower than CON at GA week 34 (−1 [−2; −0.1], | PMC10094525 | ||
3.3. Sedentary Time by the Pregnancy Physical Activity Questionnaire | At GA week 28, SED (h/day) from PPAQ was lower for EXE compared to both CON (−0.69 [−1; −0.0], Additionally, average SED (h/day) decreased among all participants (time effect) from baseline to GA week 34 (−1.1 [−1.5; −0.67], | PMC10094525 | ||
3.4. Sleep and Sedentary Time by the Activity Tracker | The unadjusted average of sleep time (h/day) for all participants was (8.2 [8.1; 8.3]), (8.0 [7.9; 8.1]) and (7.8 [7.8; 7.9]), respectively, at GA week 28, GA week 34 and delivery. Moreover, the unadjusted average SED (h/day) for all participants was (13.1 [12.9; 13.2]), (13.2 [13.0; 13.3]) and (13.5 [13.2; 13.6]), respectively, at GA week 28, GA week 34 and delivery. However, sleep time and SED did not differ significantly between groups (Compared to the baseline, the average sleep time (h/day) decreased for all participants at GA week 28 (−0.2 [−0.3; −0.1], | PMC10094525 | ||
3.5. COVID-19 Impact on Sleep and Sedentary Time as Measured by the Activity Tracker | No overall differences in sleep time and SED from randomization to delivery were found between participants ending the intervention before the COVID-19 pandemic (physical intervention only, | PMC10094525 | ||
3.6. Comparison of Sleep Time from the Activity Tracker and the Pittsburgh Sleep Quality Index | We compared sleep time from the activity tracker and PSQI. At baseline, GA week 28, and GA week 34, the correlations were weak (r = 0.17, 0.27, and 0.31 ( | PMC10094525 | ||
4. Discussion | SECONDARY | In this secondary analysis of the FitMum RCT, we found that the overall sleep quality, as determined by PSQI, was better in EXE than CON at GA week 28 and better in both EXE and MOT than CON at GA week 34. Moreover, EXE had less SED than MOT and CON at GA week 28, according to PPAQ. The activity tracker showed no significant differences between groups in sleep time and SED. However, sleep time decreased as the pregnancy progressed. SED constituted more than half of the day and increased toward the end of the pregnancy. Moreover, participants in EXE who received the intervention online due to COVID-19 restrictions had more SED than those who received the physical EXE intervention before COVID-19. | PMC10094525 | |
4.1. Effectiveness of Physical Activity Interventions on Sleep Quality as Determined by the Pittsburgh Sleep Quality Index | We observed a relatively high mean global PSQI score at baseline, which is similar to other findings among pregnant women [ | PMC10094525 | ||
4.2. Effectiveness of Physical Activity Interventions on Sedentary Time as Determined by the Pregnancy Physical Activity Questionnaire | EARLY PREGNANCY | The PPAQ showed lower SED measured in EXE compared to MOT and CON, which contradicts other findings. A 12-week unsupervised exercise intervention in early pregnancy did not affect SED [ | PMC10094525 | |
4.3. Sleep and Sedentary Time as Determined by the Activity Tracker | Like others, we found that sleep decreases [ | PMC10094525 | ||
4.4. Sedentary Time Measured by the Pregnancy Physical Activity Questionnaire and the Activity Tracker | We observed that SED increased during pregnancy when measured by the activity tracker (approx. 24 min/day) and decreased when measured by PPAQ (approx. 1 h/day). This might be explained by two previous findings from the FitMum study. First, in a validation study, we found a significant underestimation of SED by PPAQ compared to the activity tracker [ | PMC10094525 | ||
4.5. Validity of Activity Trackers for Measuring Total Sleep Time | The validity of the Garmin Vivosport in measuring sleep during pregnancy has not been tested before. One study reviewed the validity of Garmin activity trackers, not including Garmin Vivosport, in measuring sleep and found that sleep time was overestimated by the activity trackers when using a sleep diary as a criterion method [ | PMC10094525 | ||
4.6. Strengths and Limitations | PA, sleep and SED during pregnancy are difficult to evaluate accurately. It is a strength that this study utilized both reported and device-based methods at different times during pregnancy. The activity tracker was advantageous to continuously capturing sleep time and SED throughout pregnancy. However, the consumer activity tracker’s validity, adaptability, and applicability in research and clinical practice need standardization and consensus [ | PMC10094525 | ||
5. Conclusions | This study affirmed that pregnant women are prone to low sleep quality and high SED, which worsens as pregnancy progresses. Pregnant women who received structured supervised exercise training had better sleep quality and less SED than pregnant women receiving standard prenatal care when self-reported. When measured by the consumer activity tracker, no differences were observed between groups. In an online setting, due to COVID-19 restrictions, SED was increased among pregnant women who received the EXE intervention. In conclusion, interventions that increase PA levels might improve sleep quality and decrease SED in pregnant women. Future behavioral interventions targeting pregnant women should include evidence-based content to improve sleep quality and reduce SED. | PMC10094525 | ||
Author Contributions | B.S. initiated and directed FitMum. S.A.A., S.d.P.K., C.B.R., J.M.B., T.D.C., S.M., E.L. and B.S. developed the study protocol. S.d.P.K. and C.B.R. conducted intervention activities and collected data assisted by S.A.A., research assistants, and master students. E.L. was the clinical trial manager and supervised the clinical part of FitMum in collaboration with J.M.B., T.D.C., S.M. and B.S., S.A.A. performed the activity tracker data management and performed statistical analyses. A.K.J. supervised the statistical analyses. J.E.L. contributed with expertise in self-tracking, and P.J. contributed with expertise in sleep medicine. S.A.A. drafted the manuscript, supervised by B.S. All authors have read and agreed to the published version of the manuscript. | PMC10094525 | ||
Institutional Review Board Statement | The FitMum study was approved by the Danish National Committee on Health Research Ethics (#H-18011067) and the Danish Data Protection Agency (#P-2019-512). The study adheres to the principles of the Helsinki declaration and is registered at | PMC10094525 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10094525 | ||
Data Availability Statement | Due to confidentiality, the datasets utilized in the current work are not publicly accessible. However, data are available upon justifiable request from the corresponding author, obtained the Danish Data Protection Authority’s consent per the Data Protection Act, and finished a Standard Contractual Clause to ensure the transfer’s legal basis. | PMC10094525 |
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