Cardiac Rehabilitation in Decompensated Heart Failure

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

Interventions

DEVICE

Inspiratory Muscle Trainer

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.

DEVICE

Functional Electrical Stimulation

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.

OTHER

Standard medical treatment

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

Sponsors & Collaborators

• Beni-Suef University

  lead OTHER

Principal Investigators

• SHERIN HASSAN MEHANI, Professor of Physical Therapy · Faculty Of Physical Therapy Beni-Suef University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2026-08-15

Completion

2026-09-01

Countries

• Egypt

Study Locations