NCT07506499 Cardiac Rehabilitation in Decompensated Heart Failure
| NCT ID | NCT07506499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beni-Suef University |
| Condition | Decompensated Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2026-04-01 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
SHERIN HASSAN MEHANI, Professor of Physical Therapy
PRINCIPAL INVESTIGATOR
Faculty Of Physical Therapy Beni-Suef University
Frequently Asked Questions
Who can join the NCT07506499 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 65 Years, studying Decompensated Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07506499 currently recruiting?
Yes, NCT07506499 is actively recruiting participants. Contact the research team at salmaabdelfattah@pt.bsu.edu.eg for enrollment information.
Where is the NCT07506499 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07506499 clinical trial?
NCT07506499 is sponsored by Beni-Suef University. The principal investigator is SHERIN HASSAN MEHANI, Professor of Physical Therapy at Faculty Of Physical Therapy Beni-Suef University. The trial plans to enroll 135 participants.
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