- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06844591
Effects of Conditioning Exercises and Resistance Interval Training on Post CABG Patients.
February 24, 2025 updated by: Riphah International University
Comparison Between Conditioning Exercises and Resistance Interval Training on Quality of Life, Cardiorespiratory Fitness and Endurance in Post-CABG Patients
Coronary artery disease (CAD) is a global health challenge influenced by diabetes, hypertension, and psychosocial stress, with women having a higher prevalence of Coronary microvascular disease.
Promoting coronary collateral circulation offers an alternative coronary artery disease CAD treatment.
Invasive interventions like PCI and CABG aim to enhance coronary flow, restoring blood flow to ischemic myocardium.
Post-CABG challenges include depression, anxiety, and factors affecting quality of life.
Physiotherapy impacts heart rate variability, with virtual reality physiotherapy reducing both heart rate variability and hospital stay.
Cardiac rehabilitation involves lifestyle changes, enhancing functional capacity, and supporting early recovery.
Pre-operative respiratory muscle training improves outcomes.
Acute high-intensity interval exercise and mild continuous exercise benefit exercise recovery.
This research compares conditioning exercises and resistance interval training effects on post-CABG patients' well-being.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The randomized clinical trial will be conducted in physical therapy department at the District Headquarters (DHQ) in Gujranwala, employing a non-probability convenience sampling technique.
The study aims to include individuals aged 40-55 years.
Participants in phase IV cardiac rehabilitation.
Both female and male will be included.Exclusion criteria involve individuals with another clinical trial involving physical protocols.
Regular practice of physical exercise of more than 150min per week in last 3 months.
Decompensated heart failure.
Further exclusions encompass individuals who have had an acute myocardial infarction or cardiac surgery within the last 6 months, severe valvular heart diseases, uncontrolled cardiac arrhythmias, asymmetric septal hypertrophic cardiomyopathy with dynamic obstruction in the outflow pathway, musculoskeletal disorders limiting completion of the exercise program, and impaired cognitive status affecting understanding and adherence to the study protocol.
Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training.
The difference in improvement before and after 6 weeks will be documented and compared.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Gujrānwāla, Punjab, Pakistan, 52250
- Cheema Heart complex, Hospital Gujranwala
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 40-55 years
- post-coronary artery bypass graft (CABG) patients both females and males were included
- New York Heart Association criteria IV
- Hemodynamically stable patient
Exclusion Criteria:
- Fall in New York Heart Association criteria II III;
- Hemoglobin < 9 g/dL;
- Patients with peripheral or vascular problems of the lower limb,
- Cognitive and/or mental disorders;
- Exercise limiting comorbidities (primarily orthopedic, neurological condition)
- Enrollment in another clinical trial involving physical training protocols.
- Not willing to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Conditioning Exercise Group
Aerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group.
A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program.
Participants will complete a well-tested Performa.
Basic parameters will be collected through the outcome measure tool.
The difference in improvement before and after 6 weeks will be documented and compared.
|
Aerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group.
A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program.
The next activity round consisted of six x six-minute intervals of cycling and walking/uphill running on a treadmill at 60% to 85% of THR, separated by three minutes of rest/recovery.
A ten-to fifteen-minute cool- down period followed the session.
|
|
Experimental: Resistance Interval Training Group
Resistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists.
Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level.
Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider.
The workout lasted thirty to forty minutes in total.
To fit the training load, resistance and intensity were gradually raised.
For six weeks, this supervised training program was adhered to three times a week on alternate days.
The difference in improvement before and after 6 weeks will be documented and compared.
|
Resistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists.
Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level.
Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider.
The workout lasted thirty to forty minutes in total.
To fit the training load, resistance and intensity were gradually raised.
For six weeks, this supervised training program was adhered to three times a week on alternate days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-36 Questionnaire
Time Frame: 6 weeks
|
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used for quality of life, well-researched, self-reported measure of health.
It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.
The 36-Item Short Form Survey (SF-36) will be used which is a self-reported measure of health that covers eight domains of health.
|
6 weeks
|
|
6-minute walk test
Time Frame: 6 weeks
|
The 6-minute walk test (6MWT) will be used for cardiorespiratory fitness, to measure the distance walked in a specified time and reflect the functional exercise level.
The primary measurement is 6-min walk distance (6MWD), but during the 6MWT data can also be collected about the patient's blood oxygen saturation and perception of dyspnea during exertion.
When conducting the 6MWT do not walk with the patient and do not assist the patient in carrying or pulling his or her supplemental oxygen.
The patient should walk alone, not with other patients.
Do not use a treadmill on which the patient adjusts the speed and/or the slope.
Do not use an oval or circular track.
An increase in the distance walked indicates improvement in basic mobility.
Post training a difference of at least 45m should be observed for the 6 minutes' walk test to be sure that a "real" change in the patient's condition
|
6 weeks
|
|
30-second stand chair
Time Frame: 6 Weeks
|
For endurance, the sit-to-stand (STS) test measures the number of times a person can stand up from a chair in a given time (30 seconds, 1 minute, or 5 repetitions).
The 30 Second Sit to Stand Test is also known as 30 Second Chair Stand Test (30CST), was initially designed for testing leg strength and endurance in adults.
The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre- determined number of repetitions.
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6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qurat ul Ain, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Terada T, Cotie L, Noda T, Vidal-Almela S, O'Neill CD, Reed JL. Effects of High-Intensity Interval Training, Moderate-to-Vigorous Intensity Continuous Training, and Nordic Walking on Functional Fitness in Patients with Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 May 1;43(3):224-226. doi: 10.1097/HCR.0000000000000775. Epub 2023 Mar 2. No abstract available.
- Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Anabolic and Inflammatory Response to High- and Low-Load Resistance Training in Patients with Coronary Artery Disease: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2023 Jul 1;43(4):307-309. doi: 10.1097/HCR.0000000000000783. Epub 2023 Mar 6. No abstract available.
- McGregor G, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, McGuire S, Prosser J, Fiassam O, Hee SW, Hamborg T, Banerjee P, Hartfiel N, Charles JM, Edwards RT, Drane A, Ali D, Osman F, He H, Lachlan T, Haykowsky MJ, Ingle L, Shave R. High-intensity interval training in cardiac rehabilitation: a multi-centre randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):745-755. doi: 10.1093/eurjpc/zwad039.
- Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Assessment of the Early Disabling Effects of Coronary Artery Bypass Graft Surgery Using Direct Measures of Physical Function. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):28-33. doi: 10.1097/HCR.0000000000000587.
- Kristiansen J, Sjuretharson T, Grove EL, Rasmussen J, Kristensen SD, Hvas AM, Mohr M. Feasibility and impact of whole-body high-intensity interval training in patients with stable coronary artery disease: a randomised controlled trial. Sci Rep. 2022 Oct 14;12(1):17295. doi: 10.1038/s41598-022-21655-w.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2024
Primary Completion (Actual)
May 30, 2024
Study Completion (Actual)
January 15, 2025
Study Registration Dates
First Submitted
February 20, 2025
First Submitted That Met QC Criteria
February 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0322 Rubab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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