Coronary Artery DiseaseNCT06437756
Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases
A study testing Theraband resistance training and Conventional Resistance Training in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Theraband resistance training and Conventional Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases
- Conditions
- Coronary Artery Disease
- Being tested
- Theraband resistance training, Conventional Resistance Training
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraband resistance trainingOther
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.
Conventional Resistance TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Theraband resistance training | Experimental | Not described Receives: Other: Theraband resistance training |
| Conventional Resistance Training | Active comparator | Not described Receives: Other: Conventional Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Held Dynamometer
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
Measured: 6 week
Modified BORG Scale
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
Measured: 6 week
Chadler Fatigue Scale
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
Measured: 6 week
6 Min walk test (Distance in meters)
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).
Measured: 6 week
The 30 Second Sit to Stand Test(30SSST) for lower limb strength
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 May 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437756
- Sponsor's protocol ID
- REC/01808 Zunaira Shaukat
- Status last verified
- Jul 2024
- First submitted
- 27 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases
- ClinicalTrials.gov ID
- NCT06437756
- Acronym / sponsor ID
- REC/01808 Zunaira Shaukat
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theraband resistance training | Experimental | Other: Theraband resistance training |
| Conventional Resistance Training | Active comparator | Other: Conventional Resistance Training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theraband resistance trainingThree 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. | Other | Theraband resistance training |
| Conventional Resistance TrainingThe 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. | Other | Conventional Resistance Training |
Primary outcome
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
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
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 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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theraband resistance training and Conventional Resistance Training in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Held Dynamometer (time frame: 6 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.