Cardiac Rehabilitation in Decompensated Heart Failure

NCT07506499 | Recruiting

• 1 other identifier: CR-HF-BSU
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Heart Failure

Outcome Measures

Primary Outcomes (3)

• Cardiac Function (Ejection Fraction)

  Cardiac function will be assessed using echocardiography to measure left ventricular ejection fraction.

  Baseline and 4 weeks

• Maximum Inspiratory Pressure

  Inspiratory muscle strength will be assessed by measuring maximum inspiratory pressure (MIP) using a maximum inspiratory pressure meter.

  Baseline and 4 weeks

• Functional capacity (6-minute walk test)

  Functional capacity will be assessed using the 6-minute walk test (6MWT) by measuring the distance walked in meters.

  Baseline and 4 weeks

Secondary Outcomes (8)

• Dyspnea Severity

  Baseline and 4 weeks

• Quality of Life (Minnesota Living with Heart Failure Questionnaire Score)

  Baseline and 4 weeks

• Heart Rate

  Baseline and 4 weeks

• Hand Grip Strength

  Baseline and 4 weeks

• Maximum Expiratory Pressure

  Baseline and 4 weeks

Study Arms (3)

IMT + FES Group

EXPERIMENTAL

Participants receive routine medical treatment combined with inspiratory muscle training and functional electrical stimulation of the lower limb muscles as part of a cardiac rehabilitation program.

Device: Inspiratory Muscle Trainer; Device: Functional Electrical Stimulation; Other: Standard medical treatment

IMT Group

ACTIVE COMPARATOR

Participants receive routine medical treatment combined with inspiratory muscle training.

Device: Inspiratory Muscle Trainer; Other: Standard medical treatment

Control Group

ACTIVE COMPARATOR

Participants receive routine medical treatment only.

Other: Standard medical treatment

Interventions

Inspiratory Muscle Trainer DEVICE

Inspiratory muscle training performed using a threshold inspiratory muscle trainer at 30% of maximal inspiratory pressure for 30 minutes per session, 4-5 sessions per week for four weeks.

IMT + FES Group; IMT Group

Functional Electrical Stimulation DEVICE

Functional electrical stimulation will be applied to the quadriceps and gastrocnemius muscles of both lower limbs using surface electrodes. Electrical stimulation will be delivered at a frequency of 10 Hz, pulse width of 150 ms, and 20 seconds on / 20 seconds off duty cycle for approximately 45 minutes per session.

IMT + FES Group

Standard medical treatment OTHER

Participants will receive routine pharmacological treatment for heart failure according to hospital guidelines.

Control Group; IMT + FES Group; IMT Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni-Suef Governorate, Egypt

RECRUITING

Study Officials

• SHERIN HASSAN MEHANI, Professor of Physical Therapy

  Faculty Of Physical Therapy Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma mostafa Elsalhy, BSc

CONTACT

+20 1022792745; salmaabdelfattah@pt.bsu.edu.eg

MAHMOUD IBRAHIM MOHAMED, PT, PhD

CONTACT

+20 1142998414; Mahmoud.ibrahim@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)