Cardiac Rehabilitation in Decompensated Heart Failure
ConditionDecompensated Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorBeni-Suef University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Aged from 45 to 65 years old
Both sexes
Hospitalized heart failure patients with ejection fraction < 40%
Conscious and cooperative
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory Muscle Trainer
DeviceInspiratory 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.
Functional Electrical Stimulation
DeviceFunctional 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.
Standard medical treatment
Other interventionParticipants will receive routine pharmacological treatment for heart failure according to hospital guidelines.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: IMT + FES GroupExperimental treatment 3 interventions
Group B: IMT GroupActive comparator 2 interventions
Group C: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Inspiratory Pressure
Inspiratory muscle strength will be assessed by measuring maximum inspiratory pressure (MIP) using a maximum inspiratory pressure meter.
Time frame
Baseline and 4 weeksSecondary outcomes
1
Dyspnea Severity
Dyspnea severity will be assessed using the Modified Medical Research Council Dyspnea Scale (mMRC), which grades the impact of breathlessness on daily activities on a scale from 0 (minimum) to 4 (maximum), where higher scores indicate worse dyspnea severity.
Time frame
Baseline and 4 weeks2
Quality of Life (Minnesota Living with Heart Failure Questionnaire Score)
Quality of life will be evaluated using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), a 21-item questionnaire assessing the impact of heart failure on physical, emotional, and social aspects of daily life. Total scores range from 0 (minimum) to 105 (maximum), where higher scores indicate worse quality of life.
Time frame
Baseline and 4 weeks3
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.
Time frame
Baseline and 4 weeks4
Heart Rate
Resting heart rate will be measured in beats per minute (bpm) using a pulse oximeter
Time frame
Baseline and 4 weeksSponsors and contacts
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Source ClinicalTrials.gov