title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Results | Eighty-two participants were included (PBT group n = 39), with a median age of 73 years (IQR 8 years). Median Mini-BESTest scores did not clinically relevantly improve and were not significantly different between groups post-intervention (p = 0.87). FES-I scores did not change in either group. | PMC10191085 | ||
Conclusions | Participation in a PBT program including multiple perturbation types and directions did not lead to different effects than usual care on clinical measures of balance control or fear of falling in community-dwelling older adults with a recent history of falls. More research is needed to explore how to modulate PBT training dose, and which clinical outcomes are most suitable to measure training effects on balance control. | PMC10191085 | ||
Trial registration | Nederlands Trial Register NL7680. Registered 17-04-2019 – retrospectively registered. | PMC10191085 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-03988-x. | PMC10191085 | ||
Keywords | PMC10191085 | |||
Introduction | Falls annually affect one in three adults over 65 years [Balance training is reported to effectively improve balance control and reduce fall rates in older adults by approximately 24% [In recent years, perturbation-based balance training (PBT) has gained increasing interest as an intervention which is more task-specific to the recovery actions needed to prevent falls from unexpected balance perturbations. PBT aims to improve reactive balance by repeatedly exposing participants to destabilizing perturbations in a safe and controlled environment. Results from two meta-analyses indicate that PBT can significantly reduce daily-life fall rates by 46% and 52%, respectively [While current studies report promising results of PBT, they are heterogeneous in terms of training parameters, study populations, and outcomes. Further study is required to help develop effective training protocols that are tolerable and acceptable to the target population. To build upon the literature, this study will address some previous identified challenges of PBT. Firstly, studies have suggested that PBT training effects may be limited to the specific condition that was trained [In this study, we evaluate the additive effects of a three-session PBT protocol [ | PMC10191085 | ||
Methods | PMC10191085 | |||
Study design and participants | A detailed description of the full study protocol was previously published [ | PMC10191085 | ||
Interventions | Participants were randomised to receive PBT as an add-on to usual care versus usual care alone. | PMC10191085 | ||
Usual care | Usual care consisted of physiotherapy referral by the medical doctor if indicated. As in usual clinical practice, it was ultimately up to the patient to decide whether or not to visit the physiotherapist. Both the content and duration of the physiotherapy treatment could vary based on the needs of each individual patient, and were decided by the medical specialist and physiotherapist in consultation with the patient. During study visits, the outcome assessor routinely monitored if and how often each participant had visited their physiotherapist, and what components (i.e., strength training, mobility exercises, balance exercises) were included in the physiotherapy treatment. | PMC10191085 | ||
Perturbation-based balance training | Participants referred to the experimental group received usual care as described above, and three 30-minute sessions of PBT additionally. The PBT sessions were given once a week for three consecutive weeks using the Computer Assisted Rehabilitation Environment (CAREN, MOTEK Medical BV). The CAREN is a dual-belt treadmill embedded in a motion platform with 6 degrees of freedom. The treadmill and motion platform can both provide unexpected balance perturbations, such as unilateral treadmill belt accelerations or decelerations, and platform translations and rotations in various directions. This is combined with a 180-degree screen on which a virtual reality environment is projected to make training more immersive. Participants wear a safety harness during training sessions, preventing the knees from hitting the ground in case of an unsuccessful balance recovery. | PMC10191085 | ||
Training procedures | cognitive and motor dual tasks | SAID | The first training session on the CAREN started with a familiarization procedure, where the participant could get used to the system by walking on the treadmill in the virtual environment. Participants reported a numeric rating scale (NRS) score for how comfortable they felt when walking on the CAREN before and during familiarization (0; very uncomfortable to 10; fully comfortable). If a score of 7 or higher was reached, the familiarization procedure was deemed complete. This was expected to occur within 6–7 min [After this, each participants’ comfortable walking speed was determined using a ramp protocol. Subjects started walking at 0.5 m/s and speed was gradually increased until the subject said ‘stop’ when their comfortable walking speed was reached. The participant then walked unperturbed at this speed for approximately one minute to check if any adjustments needed to be made. Due to the procedures for familiarization and determining the comfortable walking speed, the total duration of the first training session could be up to 40 min.Consecutive sessions started with a warm-up during which the participant walked unperturbed on the treadmill at their comfortable speed (determined during the first session) for approximately 3 min and got readjusted to the system. Each training session consisted of three parts: gait adaptability, static and dynamic reactive balance control (of which details are given below). During training, participants were regularly asked to rate how challenging it was to maintain their balance on an NRS score (0–10; 0 = not challenging at all, 10 = unable to maintain balance). To ensure that the training was challenging but acceptable and tolerable for each participant, the aim was to train at a difficulty level between 6 and 9 (challenging to very challenging) on the NRS. Training progression was based on these NRS scores, and each participant’s ability to manage the perturbations. Training difficulty was progressed by increasing the perturbation intensity and walking speed. During the second and final training sessions, cognitive and motor dual tasks (e.g., counting backwards in steps of 7, hitting targets in the virtual environment) could also be added to increase training difficulty. Participants were aware that there would be ‘various challenges to their balance’ during the training, and were instructed to recover their balance and to try to continue walking. Participants were naïve to the timing and the order of perturbation types that would be applied. Training adherence (number of training sessions attended and completed, reasons for missed training sessions) was monitored throughout the study, and participants were encouraged to reschedule any missed training sessions. | PMC10191085 |
Gait adaptability | Participants walked in a virtual environment of a path through a forest, with various slopes and turns. Both the incline/decline of the slopes and the sharpness of the turns had a standardised starting level of 20% (out of 100%), which was then progressed in steps of 5–15%. Each 5% increase in difficulty level means an increase in the incline, decline and rotation of 0.5 degrees. | PMC10191085 | ||
Static reactive balance | standstill | Participants stood on the CAREN while the platform and treadmill belts provided sudden perturbations. The platform could shift (move in the horizontal plane) or tilt (move into a sloping position) to anterior, posterior, left and right. The treadmill belt could unilaterally accelerate from standstill. In the second and third parts of the first training session, training difficulty started at the lowest difficulty level for each participant and could be progressed individually over 7 difficulty levels. Details on perturbation characteristics for each difficulty level were published previously [ | PMC10191085 | |
Dynamic reactive balance | Participants walked on the treadmill at their comfortable walking speed, while the above-mentioned platform and treadmill perturbations were applied. The treadmill perturbations consisted of unilaterally accelerating or decelerating the treadmill belt for short periods of time (0.2–0.7 s). | PMC10191085 | ||
Measurements | EVENT | Study outcomes were measured at baseline (T0) and after 4 weeks, which was one week after the final training session for the PBT group (T1), by an outcome assessor who was blinded to treatment allocation. Demographic data (age in years, sex, body height (cm) and weight (kg)) was collected at baseline, including retrospective falls incidence over the previous 12 months. A fall was defined as ‘an event which results in a person coming to rest inadvertently on the ground or floor or lower level’ [ | PMC10191085 | |
Balance control | The main outcome in this study was balance control, assessed on the Mini-BESTest. The Mini-BESTest is a comprehensive measurement tool to assess balance in community-dwelling older adults [ | PMC10191085 | ||
Fear of falling | Fear of falling was measured with the Falls Efficacy Scale International (FES-I, Dutch version). This version of the falls efficacy scale is a 16-item questionnaire developed to determine if a person has confidence in their ability to perform a range of daily activities without falling. It has been adapted to be more suited to older adults, including a range of activities from very basic to more complex [ | PMC10191085 | ||
Sample size and randomisation | Sample size was calculated in G*power 3.1.9.2 and was based on the primary outcome of this study, difference between group means on balance measured with the Mini-BESTest post-intervention. The effect size Participants were randomised using a 1:1 ratio stratified block randomisation (block sizes 2 and 4). Randomisation was stratified based on sex (male/female) and number of falls during the previous year (1 versus 2 or more falls). The randomisation sequence was generated by an independent researcher using an online random number generator. Participants were enrolled and allocated to their groups by the main researcher. Allocation was concealed by using sequentially numbered, sealed opaque envelopes. The allocation sequence list was kept in a locked drawer, which could only be accessed by the principal investigator. | PMC10191085 | ||
Statistical analysis | gait/balance | REGRESSION | Descriptive statistics are presented as means and standard deviations (SD) or as medians and interquartile ranges (IQR), depending on the normality of the data. Categorical data is presented as frequencies (n) or percentages (%). Data was analysed on an intention-to-treat basis (missing data imputed using single stochastic regression imputation). Mann-Whitney U tests were used to determine if there was a significant between-group difference in Mini-BESTest or FES-I score change between baseline and follow-up (ΔMini-BESTest or ΔFES-I, respectively). To compare proportions or percentages between groups, the chi-square test was used. A multiple regression analysis was performed to explore potential confounding variables in the association between group and ΔMini-BESTest. Variables (age, sex, previous falls, FES-I at baseline, if the participant visited a physiotherapist and if their treatment included gait/balance training between baseline and post-intervention) were added (enter method) to the model, and variables that resulted in a ≥ 10% change in the regression coefficient of the main determinant were eligible for inclusion in the model. The variable contributing the most (≥ 10%) was included in the model first, and this process was repeated for each following variable until there were no more potential confounding factors [ | PMC10191085 |
Results | Between March 27th, 2019 and July 8th, 2021, 82 participants were included, of which 39 were randomly assigned to the PBT group (8 men, 31 women) and 43 to the control group (9 men, 34 women). The median age of the participants was 73 years (IQR 8 years). Some 49 participants experienced 1 fall during the previous year, 19 participants had fallen twice and 14 participants had fallen 3 or more times. No significant between-group differences in demographics and baseline characteristics of the participants were found (see Table
CONSORT flow-diagram of participants. Overview of participant flow from inclusion to the final measurements, including reasons for non-inclusion or drop-outs. PBT = perturbation-based balance training. Mini-BESTest = Mini Balance Evaluation Systems Test. FES-I = Falls Efficacy Scale International. Not necessary = participant did not think they needed an intervention. Travel = participant did not want to participate due to travel issues. Burden = participant considered the time investment too high (often in combination with other treatment appointments). PBT-specific = two participants did not wish to participate for reasons related to the PBT training, specifically the safety harness. COVID-19 related = participants did not wish to participate due to the COVID-19 pandemic. | PMC10191085 | ||
Training characteristics | knee pain | ADVERSE EVENT | Adherence to the training was 93.7% over all training sessions (104 out of 111 total scheduled sessions), of which 100 sessions were fully completed. Of the 37 participants who started PBT training, 31 (83.8%) attended all three training sessions. Six participants missed one or two training sessions, due to co-morbidities (n = 3), scheduling issues (n = 2) or feeling that their balance was too good for the training (n = 1). One participant reported a training-related adverse event of experiencing knee pain after making a misstep during the training session, which resolved without intervention within two days after the training session. Perturbation difficulty level was progressed individually, aiming to train at an NRS score of 6–9, representing the subjective experience of how challenging the perturbations were for each participant on a scale of 0 (not challenging) to 10 (unable to maintain balance). Progressing to higher perturbation difficulty levels (levels ranging from 1 (smallest perturbations) to 7 (largest perturbations)) based on this score, enabled the therapists to individualize training progression for each participant. By the end of the first session, participants on average reached perturbation difficulty levels 4 (range 2–6) and 2 (range 1–5) for standing and walking perturbations respectively (7 being the highest difficulty level). By the end of the third training session, participants on average reached level 6 (range 3–7) for standing perturbations and level 4 (range 2–7) for walking perturbations.
Participant characteristicsData is presented as median (interquartile range) or frequencies. Physiotherapy T0-T1 and Gait/balance training T0-T1; if participants received any physiotherapy sessions between T0 and T1, and if this training included gait and/or balance training. BMI = Body Mass Index | PMC10191085 |
Assumptions | All assumptions for statistical tests were met. An analysis of standard residuals showed that the data contained one outlier on the Mini-BESTest at T1. As this score accurately reflected the performance measured for this participant, this value was not removed from the analysis. | PMC10191085 | ||
Outcomes | REGRESSION | Table Multiple regression analysis was performed to explore and correct for potential interacting or confounding variables (age, sex, previous falls, FES-I at baseline, physiotherapy T0-T1 and Gait/Balance training T0-T1) in the association between group and ΔMini-BESTest, and between group and ΔFES-I. This analysis revealed that there was a significant interaction effect of age and receiving physiotherapy on the association between group and change in Mini-BESTest. Age also acted as a confounder in the relationship between group and change in FES-I. Adding these variables to the models did not result in a significant association in either model. Full regression analysis results and tables are reported in Additional file
Outcome measures at baseline and post-interventionOutcome measures (range of possible scores) for the control- and PBT-group at T0 (baseline) and T1 (post-intervention). Change = difference between pre- and post- outcome values. Mini-BESTest = Mini Balance Evaluation Systems Test. FES-I = Falls Efficacy Score International. Increased fall risk = the percentage of participants at increased risk for falling based on their Mini-BESTest score. Data is presented as median (IQR) or n (percentage)
Mini-BESTest scores at baseline and post-intervention in the control- and PBT groups. Mini-BESTest: Mini Balance Evaluation Systems test. T0: baseline, T1: post-intervention | PMC10191085 | |
Discussion | BBS | SECONDARY, ADVERSE EVENT | This study evaluated the effects of a PBT protocol in addition to usual care on balance control and fear of falling in older adults with a recent history of falls. We hypothesised that the PBT group would show greater improvements compared to the control group. While median Mini-BESTest scores increased slightly in both groups, these changes were below the threshold for minimal detectable change and were not significantly different between groups. Median falls efficacy scores decreased by one point in the PBT group but not in the control group, and no significant between-group differences were found. Explorative secondary analysis revealed interactive effects of age and receiving physiotherapy on the association between group and ΔMini-BESTest, while age acted as a confounding variable on the association between group and ΔFES-I. Correction for confounding variables strengthened both associations but did not lead to a significant association with group in either.The findings of this study do not support our hypothesis that balance control measured with the Mini-BESTest would improve significantly in the PBT group compared to the control group. Similar conclusions were drawn by recent studies comparing the effects of PBT to general balance training or multimodal physiotherapy on clinical measures of balance control (BBS, Timed Up and Go, and Dynamic Gait Index) in healthy community-dwelling older adults [Transfer of training adaptations to other tasks or contexts is an important challenge of PBT. Studies have shown that transfer of training adaptations can be achieved, but so far only to different conditions for a similar task. For example, studies have found transfer of PBT training adaptations after slip-perturbations on a low-friction moveable platform to a slippery floor [Additionally, while studies have shown promising beneficial effects of PBT with a single or few training sessions [No significant between-group differences were found in change of fear of falling measured with the FES-I. Median values at baseline were classified as ‘low concern’ based on previously determined cut-off values, and stayed the same for the control group and decreased by one point for the PBT group [The results of this study show high training adherence rates, one training-related adverse event, and that increasing training difficulty was possible for each participant, confirming the feasibility of this PBT protocol for participants. However, including participants in the study proved challenging. Figure | PMC10191085 |
Limitations | This study was not without limitations. Firstly, restrictions related to the COVID-19 pandemic meant that some adjustments had to be made to the treatment protocol. The inclusion criterion of having experienced a fall in the previous 3 months was broadened to the previous 6 months to increase inclusion rates and reach the required sample size after a period of lockdown measures. In retrospect, this was the case for a similar number of participants in the PBT and control groups, and if this was of significant influence this would be expected to be visible from the baseline participant characteristics. The same restrictions also meant that some of the follow-up FES-I measurements had to be done over the phone, this was the case for 2 and 3 participants in the PBT and control group, respectively. This data was collected by the same outcome assessor as the baseline measurements, and did not lead to any issues. Second, while common in intervention studies, participants and therapists in the intervention group were not blinded to group allocation. However, therapists providing usual care, outcome assessors and data analysers were blinded. Additionally, the measurements were performed by a blinded outcome assessor that encouraged all participants to give their best effort. A final limitation of this study is that no direct measures of balance control in response to perturbations were applied during training. While this was a conscious choice to enable participants to focus on their training experience, it also means that direct training effects cannot be analysed from this study. | PMC10191085 | ||
Conclusions | Participation in a PBT program that includes multiple perturbation types and directions did not lead to significantly different effects than usual care on balance control measured with the Mini-BESTest in this population of community-dwelling older adults with a recent history of falls. Fear of falling measured with the FES-I did not change in either group. More research is needed to elucidate the training dose-response relationship of PBT, and how to modulate PBT training load to attain optimal and transferrable training adaptations. Additionally, further study is needed to explore which clinical outcomes are suitable to measure PBT training effects on balance control in community-dwelling older adults. | PMC10191085 | ||
Acknowledgements | The authors would like to thank all research assistants who helped with the study measurements and data collection, and all involved doctors and nurses who helped inform potential participants about the study. | PMC10191085 | ||
Author Contribution | RS, MP | All authors were involved in the design of the study protocol. MG is the coordinating researcher, the main writer of the manuscript, involved in the data collection and training of the intervention group. RM was a major contributor in writing the manuscript and data collection, and involved in training of the intervention group. RS provided input for the writing of the manuscript and was involved in training of the intervention group. MP provided input for the writing of the manuscript and was the study doctor. RdB, KM and AL supervised the study and provided input for writing the manuscript. All authors read and approved the final manuscript. | PMC10191085 | |
Funding | The authors received no specific funding for this research. | PMC10191085 | ||
Data Availability | The datasets used and analysed during the current study are available from the corresponding author on reasonable request. | PMC10191085 | ||
Declarations | PMC10191085 | |||
Ethics approval and consent to participate | Ethics approval was obtained from the Medical Ethics Committee azM/UM (METC18-049, Medical Ethics Committee of Maastricht University and Maastricht University Medical Center), and the study was conducted in accordance with the declaration of Helsinki. All participants provided written informed consent. | PMC10191085 | ||
Consent for publication | Not applicable. | PMC10191085 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10191085 | ||
Abbreviations | trialComputer | Perturbation-based balance trainingMini balance evaluation systems testFalls efficacy scale internationalInterquartile rangeOdds ratioBerg balance scaleRandomised controlled trialComputer assisted rehabilitation environmentNumeric rating scaleMeasurement time, baselineMeasurement time, post-interventionStandard deviationChange in Mini-BESTestChange in FES-I | PMC10191085 | |
References | PMC10191085 | |||
Abstract | PMC10766135 | |||
Background | hypertensive | The benefits and safety of intensive blood pressure treatment in elderly hypertensive patients have been proved in the STEP trial. However, relevant mechanisms for intensive treatment are lacking. | PMC10766135 | |
Hypothesis | hypertensive, left ventricular systolic function | We aimed to explore whether intensive blood pressure treatment is associated with left ventricular systolic function changes as evaluated by myocardial work (MW) parameters in elderly hypertensive patients compared to the standard. | PMC10766135 | |
Methods | Patients were randomized to the intensive group ( | PMC10766135 | ||
Results | In phase 1, SBP was already significantly lower in the intensive treatment group than in the standard treatment group (126.5 vs. 132.1 mmHg, | PMC10766135 | ||
Conclusions | hypertensive | In elderly hypertensive patients, lower SBP was associated with decreased GWI and GCW and intensive BP treatment did not improve global MW efficiency.We investigated MW parameters and intensive antihypertensive treatment. We found that intensive antihypertensive treatment significantly reduced GWI and GCW from phase 1 to phase 2. Both treatment groups’ GWW increased and GWE decreased from phase 1 to phase 2. Intensive antihypertensive treatment did not reverse myocardial work in elderly hypertensives.
Xiaoxuan Feng, Mengqi Yan, and Linghui Tang contributed equally to this work.Registration: URL: | PMC10766135 | |
INTRODUCTION | Hypertensive, reduced cardiovascular events, Hypertension, ventricular hypertrophy | HYPERTENSIVE HEART DISEASE, DIASTOLIC DYSFUNCTION, HYPERTENSION, BLOOD, VENTRICULAR HYPERTROPHY | Hypertension sheds light on hypertensive heart disease (HHD) with ventricular hypertrophy processes, systolic and diastolic dysfunction, and a wider range of cardiac and vascular adaptive responses for performance.Left ventricular pressure‐strain loop (LV‐PSL) non‐invasively evaluates LV systolic function, which was first proposed by Russell et al.According to the results from the Systolic Blood Pressure Intervention Trial (SPRINT) and previously published research in the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial, intensive BP control reduced cardiovascular events and had adequate safety in elderly hypertensives. | PMC10766135 |
METHODS AND MATERIALS | PMC10766135 | |||
Study cohort | arrhythmia, congenital heart disease, valvular disease, hypertensive | MAY, ARRHYTHMIA, CARDIOMYOPATHY | We prospectively recruited elderly hypertensive patients from the Guangdong clinical center for the STEP trial between May 2017 and January 2018. Previous research detailed the trial protocol and main findings.When BP control was achieved, patients volunteered for an echocardiogram at the 1‐year (phase 1) and 3‐year (phase 2) follow‐up after randomization. Severe valvular disease, cardiomyopathy, congenital heart disease, and arrhythmia were excluded. The (Supporting Information: Table | PMC10766135 |
Anthropometry and biochemistry | Renal dysfunction, TG | RENAL DYSFUNCTION, HYPERTENSION, RECRUITMENT | Physicians gathered baseline demographic (age and sex) and anthropometric information (height and weight) during face‐to‐face recruitment visits. Standardized questionnaires were used to collect data on smoking status, duration of hypertension, medical history, and medication history. Weight in kilograms divided by height in meters squared yielded body mass index (BMI). Body surface area (BSA) was calculated by the Stevenson formula. After at least 5 minutes of rest, clinic BP readings were averaged from three consecutive measurements in the seated position taken 1 minute apart at baseline and two phases before echocardiographic evaluation. The ranges for SBP are derived from the baseline distribution in thirds. Additionally, a baseline biochemical test comprised fasting serum glucose, lipid profile consisting of total cholesterol (TC), triglycerides (TG), high‐density lipoprotein cholesterol (HDL‐C), low‐density lipoprotein cholesterol (LDL‐C), along with kidney‐related marker creatinine. The MDRD algorithm for Chinese was used to determine eGFR. Renal dysfunction was defined as eGFR <60 mL/min per 1.73 m | PMC10766135 |
Conventional echocardiographic parameters | DECUBITUS | Echocardiography was performed using a Vivid ultrasound machine (GE Healthcare) with a Vivid Iq M4S‐RS Probe (GE Ving‐Med) connected to a 2.5‐ to 3.5‐MHz phased‐array probe. The patients were examined while at rest in the left lateral decubitus posture. According to the recommendations of the European Association of Cardiovascular Imaging,Echocardiographic parameters included left atrial diameter, interventricular septum thickness, LV posterior wall thickness (PWTd) in the end‐diastolic period, which were obtained from 2D‐guided linear measurements. LV end‐diastolic volume (LVEDV), LV end‐systolic volume (LVESV) and LVEF were calculated from Teichholz's formula. Left atrial volume (LAV) was assessed utilizing the biplane method of disks at the average of the apical four‐chamber and two‐chamber. Transmitral Doppler was utilized to obtain the peak early ( | PMC10766135 | |
LV GLS and MW parameters | brachial artery BP | WASTED | GLS and MW were evaluated on three consecutive cardiac cycles by Q‐analysis with EchoPAC software (EchoPAC Version 203, GE Healthcare). 2D‐STE collected data from three apical views (4, 2, and 3 chambers) at 50 and 80 frame/s. The gathered data were then used to assess the GLS of the LV myocardium. The operating doctors verified the software's automatic endocardial contour detection and adjusted the region of interest to ensure all images had the correct edge or width. MW parameter software included brachial artery BP, LV strain, and valve opening and closure timing data. Before an echocardiographic examination, the average of three seated BP readings were used to calculate the brachial artery BP. The left ventricle's GLS was determined before entering the patient's brachial artery BP. The software calculated four main parameters: global myocardial work index (GWI, mm Hg%), the annular area expressed as LV‐PSL, showed total work from mitral valve closure to opening. Global constructive work (GCW, mm Hg%), which benefited LV ejection, represented LV systolic shortening and diastolic lengthening. Global wasted work (GWW, mm Hg%), which was unfavorable to LV ejection, consisted of LV systolic stretching and diastolic shortening. Global myocardial work efficiency (GWE, %) was estimated using the formula GCW/(GCW + GCW), demonstrating the percentage of MW. | PMC10766135 |
Intra‐ and Interobserver variability | Fifty randomly chosen participant images were remeasured by two skilled sonographers specializing in echocardiography. Sonographers were blinded to both the clinical data and each other's consequences during the process. The same sonographer re‐examined the images a month later to evaluate the intra‐observer variability. Both sonographers examined the identical images to evaluate Interobserver variability. | PMC10766135 | ||
Statistical analysis | SD | Continuous variables were expressed as mean ± SD or median with interquartile range and categorical data as absolute numbers and percentages. The Kolmogorov–Smirnov test evaluated continuous variables to assess the normality of distribution. Comparisons were made by independent samples | PMC10766135 | |
RESULTS | PMC10766135 | |||
Baseline characteristics | Sixty‐six participants were randomized to the intensive group and 50 to the standard treatment group. The median age was 66.0 (62.0–70.0) and 63.5 (61.0–69.0) years, respectively. The proportion of men in the intensive treatment group (42.4%) was larger than that in the standard treatment group (30.0%) without statistically significant difference. Smoking status was not statistically significant between the two groups (Table Baseline characteristics of the study population.*Abbreviations: IQR, interquartile range. | PMC10766135 | ||
BP and conventional echocardiographic findings | BLOOD | SBP presented a statistically significant interaction between treatment and phase (interaction Blood pressure and conventional echocardiographic parameters between two groups and study phase.
Abbreviations:
LVEDV decreased from phase 1 to phase 2 in both groups, with a significant treatment difference ( | PMC10766135 | |
GLS and MW analysis | WASTED | The analysis revealed a statistically significant phase×time interaction for GWI (GLS and myocardial work parameters between two groups and study phase.
Abbreviation: GCW, global constructive work; GLS, global longitudinal strain; GWE, global work efficiency; GWI, global work index; GWW, global wasted work.
Impact of two treatment groups at phase 1 and 2 on GLS (A), GWI (B), GCW (C), GWW (D), and GWE (E). For GLS, GWW, and GWE, there was no significant treatment × phase interaction so there was only a single | PMC10766135 | |
Regression analyses of the changes in GWI and GCW | REGRESSION | Univariate linear regression analysis showed the intensive treatment was significantly associated with ΔGCW (Univariate and multivariate linear regression analysis showing associations of clinical variables and the change of echocardiographic variables with the change of global work index and global constructive work.
Abbreviation: | PMC10766135 | |
Evaluation of intra‐ and interobserver variabilities | The Bland–Altman plots and ICC analysis of inter‐ and intraobserver agreement are shown in Supporting Information: Figure | PMC10766135 | ||
DISCUSSION | HF, cardiovascular death, LV systolic dysfunction, hypertensive, heart failure, hypertension | ACUTE MYOCARDIAL INFARCTION, HEART FAILURE, HYPERTENSION | We first examined the association of MW parameters and intensive BP treatment. Our findings indicated a significant reduction in GWI and GCW from phase 1 to phase 2 in the intensive treatment group. The standard treatment group exhibited no significant alterations in GWI and GCW. Intensive treatment was also independently correlated with ΔGWI and ΔGCW. Both groups revealed no significant difference in treatment effects in terms of LVEF and GLS. Therefore, GWI and GCW were more sensitive to the changes during intensive BP treatment than GLS and LVEF. Besides, we also discovered GWW increased and GWE decreased in the two treatment groups from phase 1 to phase 2.Few research examined BP‐lowering treatment mechanisms with MW parameters. The majority of studies examining the effects of treatment on MW parameters utilized prospective, self‐control, before‐and‐after methodologies. In contrast, our research employed a randomized, controlled approach in the subcenter STEP trial. Before‐and‐after treatment effect on sacubitril/valsartan was tested in hemodialysis patients with resistant hypertension using MW parameters.Subclinical LV systolic dysfunction is especially important for clinical prognosis in hypertensive patients with normal LVEF. Among patients without heart failure (HF) at baseline, impaired systolic function based on LVEF or strain assessment was independently correlated with incident HF, acute myocardial infarction, or cardiovascular death including elderly population.A meta‐analysis research included 1140 hypertensive patients (mean age 55.4 years, 50% men, follow‐up 6–36 months) containing 8 studies demonstrated that antihypertensive treatment was associated with the improvement in GLS.In a retrospective cross‐sectional study by Tadic et al.Ding et al. found that GWW was higher in the mild hypertension group (SBP: 140–159 mmHg) and moderate‐to‐severe hypertension group (SBP: ≥160 mmHg) than the control group (SBP: 119.3 ± 10.4 mmHg). | PMC10766135 |
LIMITATIONS | EVENTS | This study's limitations need to be discussed. Our phase 2 data were insufficient to examine cardiovascular events and mortality. Therefore, we could not determine the MW parameters' prognostic threshold values, which prevented us from demonstrating how MW parameters would affect the study's endpoint. Otherwise, no echocardiographic data were collected pre‐randomization. Additionally, we lack laboratory test results for further repeated analysis. The slightly poor quality of echocardiographic images may affect how the LV mechanics and MW were evaluated during echocardiography. Clinical research was unavoidable and did not introduce relevant bias. This study measured MW parameters utilizing clinic‐visit SBP rather than supine BP recorded during the echocardiography. The MW technique used the brachial artery BP rather than the LV wall stress to estimate LV pressure, ignoring the effect of the LV's absolute size and the wall curvature. | PMC10766135 | |
CONCLUSIONS | hypertension, hypertensive | HYPERTENSION | Our study demonstrated that MW parameters were more sensitive to the changes of systolic function during intensive BP treatment than traditional parameters. Furthermore, intensive BP treatment was associated with reduced GWI and GCW in the elderly hypertensive patients. GWW increased and GWE declined in the both groups. We demonstrated that intensive antihypertensive treatment did not reverse MW in elderly hypertensive patients. Further research of our group should pay more attention to determine the prognostic value of MW on cardiovascular outcome during the hypertension treatment. | PMC10766135 |
AUTHOR CONTRIBUTIONS | All authors have made an important scientific contribution to the study. Yingqing Feng and Linghui Tang participated in study design. Xiaoxuan Feng, Mengqi Yan, Shiping Wu, and Yingqing Feng contributed to data analysis and interpretation. Xiaoxuan Feng, Mengqi Yan, Linghui Tang, Dan Zhou, and Yingqing Feng were responsible for drafting the manuscript or revising it critically for important intellectual content. All authors listed have read and approved submission of the paper. | PMC10766135 | ||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflict of interest. | PMC10766135 | ||
Supporting information | Supporting information.Click here for additional data file.Supporting information.Click here for additional data file.Supporting information.Click here for additional data file. | PMC10766135 | ||
ACKNOWLEDGMENTS | Hypertensive | BLOOD, CARDIOVASCULAR DISEASE, CORONARY HEART DISEASE | We are grateful for the contributions made by each and every one of the people who work on the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial. We also appreciate the time and effort contributed by all participants in our study. This research was supported by the Key R&D Program of Guangdong Province (No. 2019B020227005), Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention (2017B030314041), the Climbing Plan of Guangdong Provincial People's Hospital (DFJH2020022), Guangdong Provincial Clinical Research Center for Cardiovascular disease (2020B1111170011). | PMC10766135 |
DATA AVAILABILITY STATEMENT | All data relevant to the study are included in the article. The datasets used and/or analyzed during this investigation are available upon reasonable request from the corresponding author | PMC10766135 | ||
REFERENCES | PMC10766135 | |||
Objective | MPIM on infantile eczema | Edited by: Patricia C. Heyn, Marymount University, United StatesReviewed by: Mojtaba Vaismoradi, Nord University, Norway; Pernilla Garmy, Kristianstad University, SwedenThis article was submitted to Family Medicine and Primary Care, a section of the journal Frontiers in Public HealthTo observe the influence of MPIM on infantile eczema, quality of life, growth and maternal mental state. | PMC9875301 | |
Methods | eczema | ECZEMA | This trial was a randomized controlled study. Sixty-six full-term infants with eczema were randomly divided into eczema control group (EC group, | PMC9875301 |
Results | Overall, 31 cases in HC group, 31 in EC group and 32 in EM group were included for data analysis. There were no significant differences in the indexes of infantile growth among the three groups (all | PMC9875301 | ||
Conclusion | depression, anxiety, infantile eczema | REMISSION, INFANTILE ECZEMA | MPIM could effectively promote the remission of infantile eczema and reduce its relapse, along with relieving maternal anxiety and depression mood. | PMC9875301 |
Clinical trial registration | Identifier: ChiCTR2200066246. | PMC9875301 | ||
Introduction | atopic eczema, xerosis, pruritus, Eczema, MPIM on infantile eczema, eczema | ATOPIC ECZEMA, ATOPIC DERMATITIS, XEROSIS, ECZEMA, ECZEMA | Eczema, also known as atopic eczema or atopic dermatitis, is a chronic relapsing inflammatory dermatosis characterized by pruritus, xerosis and a close association with immunoglobulin E (IgE)- mediated sensitization to aeroallergens and foods (It is noteworthy that eczema in infants also negatively influences maternal mood (Infant massage, as a common traditional practice, is widely used all over the world for both preterm and full-term infants nowadays (Therefore, this trial was designed to observe the potential influence of MPIM on infantile eczema, growth and maternal mental state, which may be a beneficial health-care method for mother-infant dyads. | PMC9875301 |
Methods | PMC9875301 | |||
Trial design | eczema | ECZEMA | The study used a prospective block-controlled randomized design shown in Flowchart of this study. MPIM, mother-performed infant massage; HC group, healthy control group; EC group, eczema control group; EM group, eczema MPIM group. | PMC9875301 |
Inclusion criteria | atopic, atopic dermatitis, eczema, infantile eczema | ATOPIC DERMATITIS, ATOPIC, INFANTILE ECZEMA, DISEASES, ECZEMA | For the infants with eczema:(1) full-term infant at or under 12 months old; (2) diagnosed as infantile eczema based on the clinical criteria for pediatric atopic dermatitis (For the healthy infants: (1) same as (1) and (3) for the infants with eczema above; (2) infants without any history of obvious visceral and functional diseases; (3) infants without eczema and other atopic diseases. | PMC9875301 |
Exclusion criteria | infection, visceral disease or dysfunction, eczema | INFECTION, ECZEMA | For the infants with eczema: (1) preterm infants or infant over 1 year old; (2) infant with any visceral disease or dysfunction except for eczema; (3) infant with infection, or the history of topical and systemic application of corticosteroids, antihistamines, antibiotics agents, traditional Chinese herbs or other specific intervention during the last 2 weeks; (4) infants with severe eczema, i.e., eczema area and severity index (EASI) score > 21 (For the healthy infants: same as (1), (3), (5), (6) and (7) for the infants with eczema above. | PMC9875301 |
Interventions | This study was a 5-month-long intervention study, which included the first 2-month intervention with regular supervision and the latter 3-month intervention without any supervision (shown in The protocol of the study.tif. | PMC9875301 | ||
Protocol in the HC group | Infants and mothers in the HC group received none of any specific intervention, except for the assessment at the three timepoints. | PMC9875301 | ||
Protocol in the EC group | skin irritants, infantile eczema | INFANTILE ECZEMA | The mothers in the EC group only received the instruction of routine care from one investigator for about half an hour in a small group of 3–5 mothers according to their convenience after the baseline observation. The tips of routine care for infantile eczema included the avoidance of skin irritants and allergens, avoidance of allergenic food in maternal and infantile diet, breast-feeding as much as possible and the application of emollient. For avoiding the confounder caused by using different emollients in this study, Pigeon skin lotion (Pigeon, Shanghai, CNH) was recommended in this study since it is popularly used on infants in China. It was advised to apply the skin lotion on the whole body of the infant except for the scalp at least twice daily, once during day time and once either after bathing or before sleep (if no bathing that day) in the evening. The used amount of the skin lotion was not fixed but determined by the body surface area and dry condition of skin in individual infant, which aimed to achieve the lubricant effect. In addition, let the infant lie on his/her stomach safely and comfortably for 10 min after the application of skin lotion before bedtime, for controlling the massaging position and time in EM group. The mothers in the EC group were instructed about infant massage by investigators after this study observation ended based on the voluntary rule. | PMC9875301 |
Protocol in the EM group | The mothers in the EM group were also instructed with the same routine care as the EC group and infant massage. The mothers were instructed with infant massage by the investigator for about 1 h in a small group of 3–5 mothers according to their convenience after the baseline observation, following the instruction about the same routine care as the EC group. The whole procedure of massage was determined according to the clinical application and textbook ( | PMC9875301 | ||
Outcome observation | PMC9875301 | |||
Weight, length, head circumference and BMI in infants | The weight, length and head circumference in infants were measured to assess infant's physical growth at the baseline, at the end of the 2- and 5-month intervention by one investigator, who was blinded from group division. The weight and length were measured by using an intelligent physical examination instrument (WS-RTG-ID, Wuhan Computer Software Development Co. LTD, China). Body mass index (BMI) was also calculated by using the following formula: BMI= weight (kg) /length (m) | PMC9875301 | ||
Eczema severity | Eczema, eczema | ECZEMA, ECZEMA | Eczema severity was assessed by using the eczema area and severity index (EASI) at the baseline and the end of the 2-month intervention, which was conducted by one blinded investigator. EASI is a simple, reliable and easily understood system, which can be used by practitioners and investigators as a baseline evaluation and to track changes of eczema condition over time ( | PMC9875301 |
Quality of life in infants with eczema | dermatitis, eczema | DERMATITIS, ECZEMA | The quality of life (QOL) in infants with eczema was evaluated by their mothers using the infants' dermatitis quality of life index (IDQOL) at the baseline and the end of the 2-month intervention. IDQOL is an easy and sensitive method with good reproducibility for parents to assess QOL impairment in infants with eczema ( | PMC9875301 |
Mental state in mothers | depression, anxiety | Maternal anxiety and depression levels were evaluated, respectively by using SAS and SDS to investigate their mental state. Mothers in the three groups completed SAS and SDS questionnaires at the baseline and the end of the 2-month intervention. SAS and SDS were designed to quantify the severity of anxiety and depression symptoms, which is widely used as a common and effective self-assessment method ( | PMC9875301 | |
Adverse event | impairment of skin, continuous crying, eating and bowel movement | ADVERSE EVENTS | During the study, the mothers and investigators observed whether there were any adverse events in the infants after intervention, including any local impairment of skin, continuous crying, any abnormal change in sleep, eating and bowel movement. | PMC9875301 |
Observation on the relapse of eczema | infantile eczema | INFANTILE ECZEMA | Since infantile eczema is a chronic relapsing inflammatory dermatosis ( | PMC9875301 |
Statistical analysis | The one-way ANOVA and χ2 test were performed to compare baseline data among groups. The repeated-measures ANOVA was performed to compare infantile growth data among groups. The student's | PMC9875301 | ||
Results | PMC9875301 | |||
Demographical data of infant-mother dyads | eczema | ECZEMA | Thirty-one dyads and 63 dyads completed the study. The demographical profile of these infant-mother dyads is shown in Demographical data of infant-mother dyads.Data are presented as the mean ± standard deviation or n/n.HC, healthy control; EC, eczema control; EM, eczema with mother-performed infant massage. | PMC9875301 |
Weight, length, head circumference and BMI in infants | As shown in Comparison of infantile growth indexes at three timepoints. | PMC9875301 | ||
Safety observation of MPIM | ADVERSE EVENTS | During the study, none of any obviously adverse events was observed and reported following MPIM or routine care except for temporal crying during BP only on the first several days in 4 cases in the EM group. | PMC9875301 | |
Adherence in routine care or MPIM | This study was also designed to observe maternal adherence condition during the latter 3-month intervention without any supervision from investigators. The investigator asked about (1) whether the mothers persisted in following instructed routine care in the EC and EM groups; (2) how often MPIM was conducted in the EM group. It was found that routine care was followed by all mothers in both groups. Nineteen mothers performed MPIM at least 6 days a week, 12 mothers 1 or 2 days a week, and only 1 mother discontinued for no special reason. | PMC9875301 | ||
Discussion | anxious mood, impaired infantile, anxiety, allergic manifestation, depression, depressive, infantile eczema, MPIM on infantile eczema, eczema | INFANTILE ECZEMA, REMISSION, ECZEMA, INFANTILE ECZEMA | This study aimed to observe the potentially positive effect of MPIM on infantile eczema, growth and the mental state in mothers. This study indicated that infantile eczema impaired infantile quality of life and negatively influenced maternal mental state. Infantile eczema improved over time after mothers followed the instructions about the routine care for infantile eczema, along with improved depressive and anxious mood in mothers. More importantly, this study demonstrated that MPIM further enhanced eczema remission and decreased its relapse rate, together with further improved mental state in mothers. However, the growth in infants with eczema was not affected by MPIM.Eczema is typically the first allergic manifestation to appear (As we all know, postpartum mothers are susceptible to depression and anxiety episodes (Two previous trials demonstrated that mother-performed massage could relieve eczema symptoms in young children (Further investigation in this study revealed the positive correlation between the levels of depression and anxiety and the severity of infant eczema. Therefore, on one side, the sleep state of infants got better with eczema improvement, which might beneficially influence the mothers sleep and mood. On the other hand, skin-to-skin contact during MPIM might trigger oxytocin (OT) production and release, which contributed to anti-stress effect and improving sleep state in mothers as previous reports (Few trials investigated the outcomes of both infants and mothers following MPIM. To our knowledge, only one trial did investigate the physical status of preterm infants and the psychological state in the mothers following MPIM, which led to greater weight, motor development, and larger bicep and thigh circumference in infants as well as increased maternal attachment and decreased anxiety compared to the control group (In addition, the correlations of EASI score with infantile scores of IDQOL and sleep and maternal scores of SAS and SDS were more significant after 2-month intervention compared with those at baseline. This result suggests that infantile quality of life and sleep and maternal mood might be affected easily by surrounding complicated factors during early postpartum stage, which may change overtime.Previous study showed that parents preferred to learn and practice infant massage on their own babies either in a class, in a hospital or at home under the investigators' supervision and instruction ( | PMC9875301 |
Limitations | eczema | ECZEMA | There are some limitations in this study. Firstly, for the convenient implementation in this pilot study, it was designed to enroll participants from one community, which might influence the real intervention effects. Secondly, this study was designed not to supervise the implementation of MPIM during the latter 3 months, aiming to observe the feasibility and adherence of MPIM. Therefore, the outcomes of infant-mother dyads at the end of 5-month intervention might be affected by the various performing frequency of MPIM. Thirdly, due to the small sample size, this study didn't analyze the potentially different effects caused by various frequency of MPIM at the end of 5-month intervention. Fourthly, this pilot study only enrolled infants and their mothers to observe the potential effect on maternal mental state. It can also extend to fathers of eczema infants who also experience worse mental state during postpartum. Fifthly, due to the study feature, mothers could not be blinded and they also assessed their own mental state and infantile quality of life, which might bring certain placebo effect. In the future, multi-centered randomized controlled trials with larger size are warranted to further investigate the potential benefits of parent-performed infant massage on the outcomes of infant-parent dyads for a prolonged time. | PMC9875301 |
Conclusion | depression, anxiety, eczema | REMISSION, ECZEMA, INFANTILE ECZEMA | In conclusion, this study demonstrated for the first time that MPIM enhanced the remission of infantile eczema, reduced the relapse rate and improved maternal depression and anxiety mood. Given its safety, cost-effectiveness and feasibility, MPIM may be recommended as a routine home healthcare method for infants with eczema in the community background. | PMC9875301 |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author. | PMC9875301 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Ethics Committee of Jiangsu Provincial Hospital of Intergrated Chinese and Western Medicine. Number of ethics approval: 2020LWKY010. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin. | PMC9875301 | ||
Author contributions | YX contributed to the conception and design of the study. LY and JL participated in the design of the manuscript and collected data. LL and YX drafted the manuscript. LL and SZ analyzed data. All authors contributed to manuscript revision, read, and approved the submitted version.We would like to thank the staffs in the Health Service Center of the Dingshan street community for the help and space provision in this study. | PMC9875301 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9875301 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.