Cardiac rehabilitation using inspiratory muscle training plus leg electrical stimulation for decompensated heart failure
Effect of Cardiac Rehabilitation in Patients With Decompensated Heart Failure
This trial will test whether adding inspiratory muscle training and lower‑limb electrical stimulation to usual care helps hospitalized patients aged 45–65 with decompensated heart failure and ejection fraction under 40% breathe better and improve functional ability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni-Suef Governorate) |
| Trial ID | NCT07506499 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled study enrolling 135 hospitalized patients with decompensated heart failure (EF < 40%) at Beni‑Suef University Hospital. Participants are randomized to receive inspiratory muscle training and functional electrical stimulation of the lower limbs in addition to standard medical treatment or to receive standard medical treatment alone. The interventions target respiratory muscle weakness and peripheral muscle dysfunction to improve inspiratory strength, exercise tolerance, and functional performance during hospitalization. Key outcomes include measures of respiratory muscle performance, exercise capacity, and functional status.
Who should consider this trial
Good fit: Ideal candidates are conscious, cooperative hospitalized patients aged 45–65 with decompensated heart failure and left ventricular ejection fraction below 40% who can actively participate in training.
Not a fit: Patients unlikely to benefit include those with acute major cardiovascular events, uncontrolled life‑threatening arrhythmias, implanted pacemakers, severe valvular disease requiring urgent surgery, end‑stage renal disease on dialysis, significant pulmonary disease, severe anemia, or exercise‑induced angina or ST changes, as well as those unable to cooperate with training.
Why it matters
Potential benefit: If successful, this combined approach could strengthen breathing muscles, reduce breathlessness, and improve mobility and overall functional capacity for patients during and after hospitalization.
How similar studies have performed: Prior studies have shown inspiratory muscle training can improve respiratory muscle strength and exercise capacity in chronic heart failure, while combining IMT with functional electrical stimulation in hospitalized decompensated patients is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Banī Suwayf, Beni-Suef Governorate
- Beni-Suef University Hospital — Banī Suwayf, Beni-Suef Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: SHERIN HASSAN MEHANI, Professor of Physical Therapy — Faculty Of Physical Therapy Beni-Suef University
- Study coordinator: Salma mostafa Elsalhy, BSc
- Email: salmaabdelfattah@pt.bsu.edu.eg
- Phone: +20 1022792745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.