Efficacy and safety of cardiac rehabilitation augmented with whole-body electrical muscle stimulation in older patients with reduced and mildly reduced ejection fraction heart failure (EMS-PL HF STUDY): a study protocol for a three-arm, parallel-group, sham-controlled, non-randomised controlled clinical trial with sequential cohort allocation
Abstract
Abstract Background Heart failure (HF) is common in older age and often compounded by sarcopenia. Exercise-based cardiac rehabilitation (CR) carries a Class I recommendation, yet many older patients with reduced (HFrEF) or mildly reduced (HFmrEF) ejection fraction cannot reach a meaningful training load because exercise capacity is limited by multiple cardiac and non-cardiac causes. Whole-body electrical muscle stimulation (WB-EMS) may build peripheral strength without added central haemodynamic stress. Aims To determine whether WB-EMS added to supervised in-hospital CR improves cardiopulmonary fitness and functional capacity in older HFrEF/HFmrEF patients, and to characterise its safety profile. Methods Single-centre, three-arm, parallel-group, sham-controlled, non-randomised trial with sequential cohort allocation. Forty-five consecutive patients aged ≥60 years with HFrEF/HFmrEF (NYHA II–III) are allocated in fixed order to standard CR plus active WB-EMS (n = 15), standard CR plus sham WB-EMS (n = 15) or standard CR alone (n = 15). The primary outcome is change in peak oxygen uptake on cardiopulmonary exercise testing. Results Recruitment began on 19 May 2025 and is ongoing; expected completion is 30 June 2027. No outcome data are reported in this protocol. Discussion The non-randomised allocation is addressed by three pre-specified sensitivity analyses: covariate-adjusted ANCOVA, calendar-time adjustment and propensity-score weighting. Reporting follows the TREND…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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