- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437756
Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases
July 2, 2024 updated by: Riphah International University
To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
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
-
-
Federal
-
Islamabad, Federal, Pakistan, 44000
- Al Nafees Medical Hospital
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants having a documented diagnosis of CAD, confirmed by a medical professional.
- Individuals with a history of myocardial infarction (heart attack), angina, or evidence of significant coronary artery stenosis.
- Stable CAD who were not experiencing acute coronary events, such as recent heart attacks or unstable angina.
- Patients who were able to perform exercises with TheraBand.
- Reduced muscle strength of upper limb/lower limb
Exclusion Criteria:
- Patients over the age of 75 years.
- Exclude individuals with a recent history of Theraband resistance training.
- Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias, or uncontrolled hypertension.
- Patients with unstable conditions or cardiac episodes.
- Individuals who had undergone major cardiovascular surgery (e.g., coronary artery bypass grafting) within the last six months.
- Ejection fraction < 40%
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Theraband resistance training
|
Three sessions of 30 minutes each was used to complete the intervention over the course of six weeks (two sets of 12 repetitions).
The participants were warmed up by stretching for 10 minutes before each session Participants were advised to take 5 mins rest before moving to next movement if they would feel fatigued after one movement.
Thera-Band was utilized in only three different colors for the workouts.
|
|
Active Comparator: Conventional Resistance Training
|
The intervention was carried out over the course of six weeks in three sessions of 30 minutes each (two sets of 12 repetitions).
The participants were warmed up by stretching for 10 minutes before each session.
The resistance-training program was performed with Universal weights.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Held Dynamometer
Time Frame: 6 week
|
If testing techniques are consistent, handheld dynamometry is a valid approach to assess the strength state and change in strength status.
Hand-held dynamometry can be a reliable assessment technique when practiced by a single experienced tester
|
6 week
|
|
Modified BORG Scale
Time Frame: 6 week
|
The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test.
Changes from the baseline will be measured
|
6 week
|
|
Chadler Fatigue Scale
Time Frame: 6 week
|
It is a self-administered questionnaire for assessing the degree and severity of fatigue/tiredness in epidemiological populations, both clinical and non-clinical.
The Chadler Fatigue Scale (CFS) was originally perceived as comprising two subscales that evaluate fatigue in the physical and mental domains.
Items are rated on a 4-point Likert scale (0 = better than usual, 1 = no more than usual, 2 = worse than usual, 3 = much worse than usual), with higher scores indicating greater fatigue.
Changes from the baseline are measured
|
6 week
|
|
6 Min walk test (Distance in meters)
Time Frame: 6 week
|
Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individuals height and weight to give an estimation of muscle versus fat in female and male of all ages.
It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square).
|
6 week
|
|
The 30 Second Sit to Stand Test(30SSST) for lower limb strength
Time Frame: 6 week
|
The 30-Second Sit to Stand Test evaluates older people's leg strength and endurance using a foldable chair without arms.
Participants stand with feet positioned back from knees, arms crossed, and arms crossed.
The examiner counts stand within 30 seconds, determining the score.
|
6 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University
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)
May 1, 2024
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
May 27, 2024
First Submitted That Met QC Criteria
May 27, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01808 Zunaira Shaukat
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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