- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07519473
Neuromuscular Versus Resistance Training on Functional Capacity in Patients With Heart Failure.
Comparative Effects Between Neuromuscular Versus Resistance Training on Functional Capacity, Cardiorespiratory Fitness, and Lower Limb Performance in Patients With Heart Failure.
This randomized controlled trial will compare the effects of neuromuscular training and resistance training on functional capacity, cardiorespiratory fitness, and lower limb performance in patients with chronic heart failure. A total of 40 participants will be randomly assigned into two groups in a single-blinded design.
Both groups will undergo a 10-week supervised exercise program. Outcomes will be assessed using VO₂ peak, 6-Minute Walk Test (6MWT), Short Physical Performance Battery (SPPB), and quality of life measures.
The study aims to determine the more effective rehabilitation approach for improving clinical outcomes in heart failure patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Heart failure is a chronic and progressive condition associated with reduced functional capacity, impaired cardiorespiratory fitness, and decreased lower limb performance, significantly affecting quality of life. Exercise-based cardiac rehabilitation is an established intervention; however, the comparative effectiveness of different exercise modalities, particularly neuromuscular training and resistance training, remains insufficiently explored.
This study is a single-blinded randomized controlled trial designed to compare the effects of neuromuscular training and resistance training on functional capacity, cardiorespiratory fitness, and lower limb performance in patients with chronic heart failure. A total of 40 participants meeting the inclusion criteria will be recruited from tertiary care hospitals and cardiac rehabilitation centers. After baseline assessment, participants will be randomly allocated into two groups using a concealed allocation method.
Both groups will undergo a supervised 10-week intervention program consisting of 20 sessions (2 sessions per week). Each session will include warm-up, 20 minutes of specific training, 20 minutes of moderate-intensity aerobic exercise, and cool-down. The resistance training group will perform exercises targeting major muscle groups at moderate intensity (50-70% of one-repetition maximum), while the neuromuscular training group will focus on balance, coordination, proprioception, and motor control using structured functional exercises.
Primary outcome measures will include cardiorespiratory fitness (VO₂ peak assessed via Chester Step Test), functional capacity (6-Minute Walk Test), and lower limb performance (Short Physical Performance Battery). Secondary outcomes will include resting heart rate, blood pressure, oxygen saturation, perceived exertion (Borg CR-10), and quality of life measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Assessments will be conducted at baseline and after completion of the intervention by a blinded assessor to minimize bias. Data will be analyzed using appropriate statistical methods to compare within-group and between-group differences.
This study aims to generate evidence on the comparative effectiveness of neuromuscular and resistance training, which may help in optimizing cardiac rehabilitation protocols and improving clinical outcomes in patients with heart failure.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Iqbal Tariq, Phd*
- Phone Number: 03338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 40100
- community based Cardiac Rehab Unit, Cardiac Centers, and Tertiary Care Hospitals
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Contact:
- Arjumand Bano, MS-CPPT
- Phone Number: 03059551883
- Email: arjumand.bano@riphah.edu.pk
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Principal Investigator:
- syeda Fizza Kazmi, MS-CPPT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female patients aged 40-60 years
- Diagnosed with chronic heart failure ≥ 1 year
- Heart failure with reduced ejection fraction (HFrEF), EF ≤ 40%
- NYHA Class II-III
- Low to moderate exercise risk (based on Chester Step Test)
- On stable pharmacological treatment for ≥ 6 weeks
- Able to understand and follow exercise instructions
Exclusion Criteria:
- Absolute contraindications to exercise (e.g., recent MI, unstable angina, uncontrolled arrhythmias, severe aortic stenosis, decompensated HF)
- Abnormal CPET findings (severe arrhythmias, ischemia, ST depression)
- Abnormal blood pressure response during exercise
- Exercise-induced angina or thoracic pain
- Musculoskeletal, neurological, or cognitive impairments limiting exercise participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance Training Group
Participants in this group will undergo a supervised resistance training program targeting major upper and lower limb muscle groups.
Training will be performed at moderate intensity (50-70% of one-repetition maximum) using resistance bands, machines, and bodyweight exercises.
Each session will also include 20 minutes of moderate-intensity aerobic exercise, along with warm-up and cool-down, conducted twice weekly for 10 weeks.
|
A supervised resistance training program targeting major muscle groups using resistance bands, machines, and bodyweight exercises.
Training intensity will be set at 50-70% of one-repetition maximum and progressed based on patient tolerance.
Each session will include warm-up, 20 minutes of resistance exercises, 20 minutes of moderate-intensity aerobic exercise, and cool-down.
Sessions will be conducted twice weekly for 10 weeks.
Other Names:
|
|
Experimental: Neuromuscular Training Group
Participants in this group will undergo a supervised neuromuscular training program focusing on balance, coordination, proprioception, postural control, and motor control exercises.
Training will include dynamic balance activities, limb coordination tasks, and exercises using unstable surfaces.
Each session will also include 20 minutes of moderate-intensity aerobic exercise, along with warm-up and cool-down, conducted twice weekly for 10 weeks.
|
A supervised neuromuscular training program focusing on balance, coordination, proprioception, and postural control.
Exercises will include dynamic balance tasks, limb coordination, and training on unstable surfaces.
Each session will include warm-up, 20 minutes of neuromuscular exercises, 20 minutes of moderate-intensity aerobic exercise, and cool-down.
Sessions will be conducted twice weekly for 10 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Capacity
Time Frame: Baseline and after 10 weeks of intervention
|
Functional capacity will be assessed using the Six-Minute Walk Test (6MWT), which measures the distance a participant can walk on a flat surface in 6 minutes.
It is a validated and reliable measure used in cardiac rehabilitation to evaluate exercise tolerance and daily functional ability in patients with heart failure.
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Baseline and after 10 weeks of intervention
|
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Cardiorespiratory Fitness (VO₂ Peak)
Time Frame: Baseline and after 10 weeks of intervention
|
Cardiorespiratory fitness will be assessed using the Chester Step Test, which estimates VO₂ peak based on heart rate response during graded stepping exercise.
VO₂ peak is a key indicator of aerobic capacity and cardiovascular health in patients with heart failure.
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Baseline and after 10 weeks of intervention
|
|
Lower Limb Performance
Time Frame: Baseline and after 10 weeks of intervention
|
Lower limb performance will be assessed using the Short Physical Performance Battery (SPPB), which includes balance tests, gait speed, and chair stand tests.
It is a validated tool for assessing lower extremity function in clinical populations.
|
Baseline and after 10 weeks of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arjumand Bano, MSPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Heart Diseases
- Heart Failure
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Exercise Therapy
- Resistance Training
Other Study ID Numbers
- REC/RCR & AHS/25/0321
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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