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Recruiting NCT07506499

Cardiac Rehabilitation in Decompensated Heart Failure

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Trial Parameters

Condition Decompensated Heart Failure
Sponsor Beni-Suef University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 135
Sex ALL
Min Age 45 Years
Max Age 65 Years
Start Date 2026-04-01
Completion 2026-05-15
Interventions
Inspiratory Muscle TrainerFunctional Electrical StimulationStandard medical treatment

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * Aged from 45 to 65 years old * Both sexes * Hospitalized heart failure patients with ejection fraction \< 40% * Conscious and cooperative * Able to participate in training actively Exclusion Criteria: * Acute major cardiovascular events (e.g., acute coronary syndrome, stroke, or pulmonary embolism) * Uncontrolled life-threatening arrhythmias * Severe valvular heart disease requiring urgent surgery * Pregnancy * End-stage renal disease requiring dialysis * Significant pulmonary diseases such as pulmonary arterial hypertension, * Implanted pacemaker * Clinically significant peripheral vascular disease * Severe anemia * Exercise-induced angina or ST-segment changes

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