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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06437756
Other study ID # REC/01808 Zunaira Shaukat
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date July 10, 2024

Study information

Verified date May 2024
Source Riphah International University
Contact Muhammad Iqbal Tariq, PhD*
Phone 03338236752
Email iqbal.tariq@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date July 10, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
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.
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.

Locations

Country Name City State
Pakistan Al Nafees Medical Hospital Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 week
Primary 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 6 week
Primary 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 6 week
Primary 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). 6 week
Primary 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. 6 week
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