Clinical Trial

Cardiac Rehabilitation in Decompensated Heart Failure

Recruiting
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Record status
This record was last updated August 6, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
Heart failure is a common clinical condition that often leads to reduced exercise tolerance, shortness of breath, and poor quality of life. Many patients with heart failure also develop weakness of the inspiratory muscles, which contributes to limited physical activity and worsening functional capacity. Inspiratory muscle training (IMT) has been suggested as a useful rehabilitation method to improve respiratory muscle strength and exercise tolerance. In addition, functional electrical stimulation (FES) of the lower limb muscles may help activate skeletal muscles and improve functional performance in patients who cannot tolerate conventional exercise. This randomized controlled study aims to investigate the effect of combining inspiratory muscle training with functional electrical stimulation of the lower limbs in patients with decompensated heart failure. A total of 135 hospitalized patients with decompensated heart failure will be recruited from the Cardiology Department at Beni-Suef University Hospital and randomly assigned into three groups. Group A (45 patients) will receive routine medical treatment in addition to inspiratory muscle training combined with functional electrical stimulation. Group B (45 patients) will receive routine medical treatment with inspiratory muscle training only. Group C (45 patients) will receive routine medical treatment alone. The intervention will start during hospitalization and will continue for four weeks. The study will evaluate the effects of these interventions on cardiac function, inspiratory muscle strength, and functional capacity as primary outcomes. Secondary outcomes will include dyspnea severity, quality of life, heart rate, oxygen saturation, hand grip strength, and maximum expiratory pressure. The findings of this study may help clarify the potential role of combining inspiratory muscle training with functional electrical stimulation as part of cardiac rehabilitation in patients with decompensated heart failure.
Protocol Amendment History 6 changes
critical Primary endpoint(s) modified 2026-08-07
notable Primary completion pushed: 2026-06-15 -> 2026-08-15 2026-08-07
minor Completion pushed: 2026-07-01 -> 2026-09-01 2026-08-07
notable Primary completion pushed: 2026-05-15 -> 2026-06-15 2026-04-16
minor Completion pushed: 2026-06-01 -> 2026-07-01 2026-04-16
critical Recruitment opened 2026-04-09
Trial Details
NCT Number NCT07506499
Lead Sponsor Beni-Suef University
Conditions Decompensated Heart Failure
Enrollment 135 participants
Start Date 2026-04-01
Primary Completion 2026-08-15 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-06