Effect of Cardiac Rehabilitation in Patients With Decompensated Heart Failure
Trial tests breathing and leg exercises for severe heart failure
Plain English Summary
Cardiac Rehabilitation in Decompensated Heart Failure is a Not Applicable clinical trial sponsored by Beni-Suef University studying Decompensated Heart Failure. This study tests if a combination of breathing exercises and electrical stimulation of leg muscles can improve the health of patients with severe heart failure. It is for hospitalized patients aged 45-65 with a specific type of heart failure (ejection fraction < 40%). Participants will receive standard care plus breathing exercises and/or leg stimulation for four weeks. Alternatives include standard medical treatment alone or with breathing exercises only. The trial aims to enroll 135 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 45 and 65 years old, are hospitalized for heart failure with a weakened heart pump (ejection fraction less than 40%), and can actively participate in exercises. You cannot join if you have had a recent major heart or lung event, uncontrolled irregular heartbeats, need urgent heart valve surgery, are pregnant, have kidney failure requiring dialysis, or have severe lung disease. Other reasons for exclusion include having a pacemaker, significant leg artery disease, severe anemia, or chest pain during exercise. This trial is studying Decompensated Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goals are to see if the exercises improve the heart's pumping ability, how strongly you can inhale, and how far you can walk in six minutes, indicating better physical function. The specific primary outcome measures are: Cardiac Function (Ejection Fraction) (Baseline and 4 weeks); Maximum Inspiratory Pressure (Baseline and 4 weeks); Functional capacity (6-minute walk test) (Baseline and 4 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to find better ways to help patients with severe heart failure improve their breathing, strength, and ability to be active, addressing a gap in current rehabilitation options. This research targets Decompensated Heart Failure, where improved treatment options are needed.
Investor Insight
This trial explores novel rehabilitation techniques for a common and serious condition, potentially leading to new treatment protocols if successful.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you and what the specific exercises involve. Participation will involve daily breathing exercises and/or electrical stimulation of your leg muscles for about 45 minutes, in addition to your regular hospital care, for four weeks. You will undergo tests at the beginning and end of the four-week period to measure your progress. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 135 participants
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.
Primary Outcomes
- Cardiac Function (Ejection Fraction) (Baseline and 4 weeks)
- Maximum Inspiratory Pressure (Baseline and 4 weeks)
- Functional capacity (6-minute walk test) (Baseline and 4 weeks)
Secondary Outcomes
- 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)
Full Eligibility 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
Trial Locations
- Beni-Suef University Hospital, Banī Suwayf, Beni-Suef Governorate, Egypt
Frequently Asked Questions
What is clinical trial NCT07506499?
NCT07506499 is a Not Applicable INTERVENTIONAL study titled "Cardiac Rehabilitation in Decompensated Heart Failure." It is currently not yet recruiting and is sponsored by Beni-Suef University. The trial targets enrollment of 135 participants.
What conditions does NCT07506499 study?
This trial investigates treatments for Decompensated Heart Failure. The primary condition under study is Decompensated Heart Failure.
What treatments are being tested in NCT07506499?
The interventions being studied include: Inspiratory Muscle Trainer (DEVICE), Functional Electrical Stimulation (DEVICE), Standard medical treatment (OTHER). 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.
What does Not Applicable mean for NCT07506499?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07506499?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2026-06-01.
Who is sponsoring NCT07506499?
NCT07506499 is sponsored by Beni-Suef University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07506499?
The trial aims to enroll 135 participants. The trial has not yet started recruiting.
How is NCT07506499 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07506499?
The primary outcome measures are: Cardiac Function (Ejection Fraction) (Baseline and 4 weeks); Maximum Inspiratory Pressure (Baseline and 4 weeks); Functional capacity (6-minute walk test) (Baseline and 4 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07506499 being conducted?
This trial is being conducted at 1 site, including Banī Suwayf, Beni-Suef Governorate (Egypt).
Where can I find official information about NCT07506499?
The official record for NCT07506499 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07506499. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07506499 testing in simple terms?
This study tests if a combination of breathing exercises and electrical stimulation of leg muscles can improve the health of patients with severe heart failure. It is for hospitalized patients aged 45-65 with a specific type of heart failure (ejection fraction < 40%).
Why is this trial significant?
This trial aims to find better ways to help patients with severe heart failure improve their breathing, strength, and ability to be active, addressing a gap in current rehabilitation options.
What are the potential risks of participating in NCT07506499?
Potential risks include muscle soreness or discomfort from the exercises or electrical stimulation. There is a small risk of breathing difficulties or dizziness during the exercises. As with any medical intervention, there's a possibility of unexpected reactions or side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07506499?
Ask your doctor if this trial is right for you and what the specific exercises involve. Participation will involve daily breathing exercises and/or electrical stimulation of your leg muscles for about 45 minutes, in addition to your regular hospital care, for four weeks. You will undergo tests at the beginning and end of the four-week period to measure your progress. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07506499 signal from an investment perspective?
This trial explores novel rehabilitation techniques for a common and serious condition, potentially leading to new treatment protocols if successful. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive standard care plus breathing exercises and/or leg stimulation for four weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.