- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07331584
Elastic Band Versus Free Weight Resistance Training in Phase 2 of CABG Patients.
Effects of Elastic Band Versus Free Weight Resistance Training on Functional Capacity, Pulmonary Functioning and Quality of Life in Phase 2 of CABG Patients.
Study Overview
Detailed Description
Patients who undergo cardiac surgery frequently faces pulmonary complications. This study aims to compare the effects of elastic band and free weights on functional capacity, lung function and quality of life in phase 2 coronary artery bypass grafting patients. Resistance training is vital in cardiac rehabilitation for improving physical function, strength, and independence. These patients typically experience reduced functional capacity and lung function due to post-surgical deconditioning and inactivity, which can also impact quality of life. Determining whether elastic bands or free weights provide greater benefits in these areas may help optimize cardiac rehabilitation protocols by identifying a safe, effective, and accessible approach for improving patient outcomes.
This research has the potential to guide evidence-based resistance training in post- coronary artery bypass grafting rehabilitation, ultimately supporting recovery and enhancing quality of life of patients. By comparing the effects of elastic band versus free weights resistance training on functional capacity, pulmonary functioning and quality of life in phase 2 of coronary artery bypass grafting. It will be a randomized clinical trial. Age of selected patients will be between 45 to 65 years and data will be collected from them. There will be two groups i.e. group A will receive 10 min walk warm up after that resistance training of upper and lower limb by using dumb bells and group B will receive 10 min of walk as warm up after that resistance training of upper and lower limb by using elastic band. International physical activity questionnaire used for quality of life, 6 min walk test for functional capacity and forced expiratory volume, forced vital capacity and peak expiratory flow rate for lung functioning.
Trial will be completed in 12 weeks (2x/week) after patients got discharged 4-8 weeks after the surgery and before and after each session, primary and secondary outcomes will be measured for both groups. After data collection, data will be analyzed using SPSS version 25
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 42000
- Sehat medical complex hanjerwal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male and female
- Age (45-64)
- Stable cardio vascular status
- Able to participate in mild to moderate exercise
- Must be in 4-8 week of CABG and medically cleared for phase 2.
- Able to provide informed consent
Exclusion Criteria:
Unstable cardiovascular condition.
- Pulmonary conditions
- Cognitive impairment
- Other major surgeries and comorbidities
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: Dumbell
Group A will receive the exercises from dumb bells we will focus on both upper limb and lower limb the total session would be of 20-30 minutes, will be focusing on chest (pectoralis major), back (latissimus dorsi, rhomboids), legs (quadriceps, hamstring, glutes) and core (abdominals, lower back) and after that 5-7 min of cool down.
Dyspnea will be measured.
|
Group A will receive the exercises from dumb bells we will focus on both upper limb and lower limb the total session would be of 20-30 minutes, will be focusing on chest (pectoralis major), back (latissimus dorsi, rhomboids), legs (quadriceps, hamstring, glutes) and core (abdominals, lower back) and after that 5-7 min of cool down.
Dyspnea will be measured.
Group B will receive the exercise form elastic band (TheraBand) for both upper limb and lower limb.
Total session time would be 30 minutes will be focusing on chest (pectoralis major), back (latissimus dorsi, rhomboids), legs (quadriceps, hamstring, glutes) and core (abdominals, lower back) 10-12 reps and 1 set in starting progressively increased to 3 reps after that at the end of session 5-7 min cool down and gentle stretching 2 times per week for 12 weeks.
Dyspnea should be monitored.
|
|
Experimental: elastic band
Group B will receive the exercise form elastic band (TheraBand) for both upper limb and lower limb.
Total session time would be 30 minutes will be focusing on chest (pectoralis major), back (latissimus dorsi, rhomboids), legs (quadriceps, hamstring, glutes) and core (abdominals, lower back) 10-12 reps and 1 set in starting progressively increased to 3 reps after that at the end of session 5-7 min cool down and gentle stretching 2 times per week for 12 weeks.
Dyspnea should be monitored.
|
Group A will receive the exercises from dumb bells we will focus on both upper limb and lower limb the total session would be of 20-30 minutes, will be focusing on chest (pectoralis major), back (latissimus dorsi, rhomboids), legs (quadriceps, hamstring, glutes) and core (abdominals, lower back) and after that 5-7 min of cool down.
Dyspnea will be measured.
Group B will receive the exercise form elastic band (TheraBand) for both upper limb and lower limb.
Total session time would be 30 minutes will be focusing on chest (pectoralis major), back (latissimus dorsi, rhomboids), legs (quadriceps, hamstring, glutes) and core (abdominals, lower back) 10-12 reps and 1 set in starting progressively increased to 3 reps after that at the end of session 5-7 min cool down and gentle stretching 2 times per week for 12 weeks.
Dyspnea should be monitored.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in 1 Second
Time Frame: 12 weeks
|
Forced Expiratory Volume in 1 Second (FEV1) is a key lung function test measuring how much air you can forcefully blow out in the first second of a deep breath, indicating how quickly your airways empty.
|
12 weeks
|
|
international physical activity questionnaire : Quality of life
Time Frame: 12 week
|
The international physical activity questionnaire is a widely used tool designed to assess physical activity levels among adults.
It evaluates various types of activity, including walking, moderateintensity activities, and vigorous-intensity activities, over the past week.
The International Physical Activity Questionnaire (IPAQ) scoring involves converting reported activity (walking, moderate, vigorous) into MET-minutes per week by multiplying minutes by MET values (3.3 for walking, 4 for moderate, 8 for vigorous).
Scores are then categorized as Low, Moderate, or High, based on specific criteria like achieving ≥3000 MET-min/week (High) or meeting minimum days/minutes for moderate activity (e.g., ≥3 days vigorous or ≥5 days moderate/walking for Moderate), to assess overall activity levels.
|
12 week
|
|
6 Minute Walk Test
Time Frame: 12 weeks
|
A 6 min walk test is easier, safer to administer, better tolerated and better reflects activity of daily Living than another walk test.
The 6-Minute Walk Test (6MWT) scoring primarily focuses on the total distance walked (6MWD) in meters, calculated by counting laps and adding any partial lap, noting rest times.
Scores are interpreted using age/sex/height/weight-specific prediction equations (like those from the American Thoracic Society) to compare actual distance to expected normal, with lower scores indicating poorer function, though the longest distance from multiple tests is used to account for learning effects.
|
12 weeks
|
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Forced Vital Capacity
Time Frame: 12 week
|
FVC, or Forced Vital Capacity, is a key measurement in spirometry (lung function tests) that quantifies the total amount of air you can forcefully exhale from your lungs after taking the deepest breath
|
12 week
|
|
Peak Expiratory Flow Rate
Time Frame: 12 Week
|
Peak Expiratory Flow Rate (PEFR) measures the fastest speed you can forcefully exhale air from your lungs
|
12 Week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Riffat Malik, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Fatima Shoaib
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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