An interventional study of Inspiratory Muscle Trainer and Functional Electrical Stimulation in Decompensated Heart Failure, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
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.
Heart failure is a progressive clinical syndrome in which the heart is unable to maintain adequate cardiac output to meet the body's metabolic demands. Decompensated heart failure represents an acute or subacute deterioration requiring hospitalization and is associated with significant morbidity, prolonged hospital stays, and high readmission rates. Beyond the primary cardiac impairment, patients with decompensated heart failure commonly develop secondary systemic consequences, including respiratory muscle dysfunction and peripheral skeletal muscle abnormalities, both of which contribute independently to exercise intolerance, symptom burden, and poor functional outcomes.
Inspiratory muscle weakness has been identified in approximately 30-50% of patients with heart failure and is believed to result from a combination of diaphragmatic underperfusion, chronic hyperventilation, and systemic inflammatory and catabolic processes. This weakness leads to increased work of breathing, ventilatory inefficiency, and heightened perception of dyspnea, creating a vicious cycle that further limits physical activity and accelerates functional decline. Inspiratory muscle training (IMT) targets this mechanism by applying progressive resistive loading to the inspiratory muscles, promoting improvements in diaphragmatic strength, ventilatory efficiency, and autonomic modulation. Several studies have demonstrated favorable effects of IMT on inspiratory muscle performance, exercise capacity, and quality of life in stable heart failure populations; however, evidence regarding its application during the acute decompensated phase remains limited.
Peripheral skeletal muscle dysfunction in heart failure is characterized by a shift from type I oxidative to type II glycolytic muscle fibers, reduced mitochondrial density, impaired oxygen utilization, and muscle atrophy driven by disuse, neurohormonal activation, and systemic inflammation. These changes are particularly pronounced during periods of decompensation and prolonged bed rest. Functional electrical stimulation (FES) offers a passive approach to muscle activation that bypasses the cardiovascular demand of voluntary exercise, making it a potentially suitable intervention for hemodynamically unstable or severely deconditioned patients. FES-induced muscle contractions have been shown to improve local blood flow, enhance oxidative enzyme activity, and promote favorable fiber-type remodeling in heart failure populations.
Despite the established individual benefits of IMT and FES, no study to date has investigated the combined application of these two modalities in patients hospitalized with decompensated heart failure. The physiological rationale for combining them is based on the concept of addressing both central (respiratory muscle) and peripheral (skeletal muscle) components of exercise intolerance simultaneously, which may produce additive or synergistic improvements in functional capacity and clinical outcomes compared to either intervention alone.
This study hypothesizes that the addition of combined IMT and FES to routine medical treatment will result in greater improvements in cardiac function, inspiratory muscle strength, and functional capacity compared to IMT alone or medical treatment alone in patients with decompensated heart failure. The findings may contribute to the development of early, comprehensive cardiac rehabilitation strategies for this high-risk population.
Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants receive routine medical treatment combined with inspiratory muscle training.
Device: Inspiratory Muscle Trainer · Other: Standard medical treatment
Participants receive routine medical treatment only.
Other: Standard medical treatment
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.
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.
Participants will receive routine pharmacological treatment for heart failure according to hospital guidelines.
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 weeks
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 weeks
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 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.
Time frame: Baseline and 4 weeks
Heart Rate
Resting heart rate will be measured in beats per minute (bpm) using a pulse oximeter
Time frame: Baseline and 4 weeks
Hand Grip Strength
Hand grip strength will be measured using a hand grip dynamometer to assess peripheral muscle strength.
Time frame: Baseline and 4 weeks
Maximum Expiratory Pressure
Expiratory muscle strength will be assessed by measuring maximum expiratory pressure (MEP) using a maximum expiratory pressure meter.
Time frame: Baseline and 4 weeks
Length of Hospital Stay
Length of hospital stay will be measured as the number of days from hospital admission to hospital discharge.
Time frame: During the hospitalization period (Up to 7 days)
Estimated peak oxygen uptake (VO₂max)
Estimated VO₂max (mL/kg/min) calculated from the Duke Activity Status Index (DASI) using a validated published equation
Time frame: Baseline and 4 weeks
Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured as a percentage (%) at rest using a pulse oximeter
Time frame: Baseline and 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beni-Suef University