Protocol for EACH-ADHF trial: efficacy and safety of early comprehensive rehabilitation in patients with acute decompensated heart failure - a multicentre, randomised controlled trial.
Acute decompensated heart failure (ADHF) is associated with high mortality rates and significant decline in physical function following hospitalisation. Although exercise-based cardiac rehabilitation is recognised as a key component of comprehensive heart failure management, clinical evidence supporting its application in patients with ADHF remains limited. The trial aims to evaluate the efficacy and safety of an early initiated comprehensive rehabilitation in patients with ADHF.
This is a prospective, multicentre, randomised, open-label, parallel-group clinical trial. A total of 140 patients hospitalised with ADHF will be enrolled and randomised in a 1:1 ratio to receive either comprehensive rehabilitation intervention or attention control. The intervention group will receive a supervised, 6-week structured comprehensive rehabilitation programme consisting of progressive balance, endurance, strength and inspiratory muscle training. Rehabilitation therapy commences after admission and continues into the outpatient period with a total of 18 sessions. The control group will receive standard usual care supplemented by fortnightly non-rehabilitation-related contact from study personnel to control for attention. Coprimary outcomes are changes in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score and in maximum inspiratory pressure expressed as a percentage of predicted value (PImax%pred) at 6 weeks postrandomisation. Secondary outcomes include changes in the Short Physical Performance Battery score, frailty phenotype, pulmonary function tests and 6-month all-cause rehospitalisation.
The Early Comprehensive Rehabilitation in patients with ADHF (EACH-ADHF) trial was granted by the Medical Research Ethics Committee of Guangdong Provincial People's Hospital (KY-Q-2022-487). Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.
NCT06161987.
This is a prospective, multicentre, randomised, open-label, parallel-group clinical trial. A total of 140 patients hospitalised with ADHF will be enrolled and randomised in a 1:1 ratio to receive either comprehensive rehabilitation intervention or attention control. The intervention group will receive a supervised, 6-week structured comprehensive rehabilitation programme consisting of progressive balance, endurance, strength and inspiratory muscle training. Rehabilitation therapy commences after admission and continues into the outpatient period with a total of 18 sessions. The control group will receive standard usual care supplemented by fortnightly non-rehabilitation-related contact from study personnel to control for attention. Coprimary outcomes are changes in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score and in maximum inspiratory pressure expressed as a percentage of predicted value (PImax%pred) at 6 weeks postrandomisation. Secondary outcomes include changes in the Short Physical Performance Battery score, frailty phenotype, pulmonary function tests and 6-month all-cause rehospitalisation.
The Early Comprehensive Rehabilitation in patients with ADHF (EACH-ADHF) trial was granted by the Medical Research Ethics Committee of Guangdong Provincial People's Hospital (KY-Q-2022-487). Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.
NCT06161987.
Authors
Xu Xu, Chang Chang, Guo Guo, Bai Bai, Wang Wang, Liu Liu, Du Du, Mao Mao, Xue Xue, Su Su, Wang Wang, Lin Lin, Ma Ma
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