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The effects of thera band exercises on muscle strength, quality of life and anthropometric changes of myocardial infarction patients at institute of cardiology, National Hospital Sri Lanka
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SLCTR Registration Number
SLCTR/2020/021
Date of Registration
The date of last modification
Aug 26, 2022
Scientific Title of Trial
The effects of thera band exercises on muscle strength, quality of life and anthropometric changes of myocardial infarction patients at institute of cardiology, National Hospital Sri Lanka
Public Title of Trial
The effects of thera band exercises on muscle strength, quality of life, and anthropometric changes of patients with myocardial infarction at the Institute of cardiology, National Hospital Sri Lanka – A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Myocardial Infarction
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1259-1408
Any other number(s) assigned to the trial and issuing authority
UCP/AL/16/350:ERC Colombo
What is the research question being addressed?
Does thera band exercises affect muscle strength, quality of life, and cause anthropometric changes in patients with myocardial infarction?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Institute of cardiology, National Hospital of Sri Lanka.
Randomization: 40 participants with myocardial infarction will be assessed and 20 patients each will be randomized to intervention and control groups using a simple random sampling method. The first subject will be randomized to the control or intervention group by tossing a coin (heads-control, tails- treatment). Subsequently, the study subjects will be allocated alternatively to either group until such point that the expected sample number is reached.
Intervention: The intervention will include 30 minute thera band exercises for the major muscle groups of upper and lower limbs. From upper limb muscles we will strengthen shoulder flexors, shoulder abductors and elbow flexors. From lower limb muscles we will strengthen hip abductors, quadriceps muscle group and calf muscles. This thera band exercise programme is guided by the principal investigator with the help of the chief physiotherapist. The thera band exercise programme will be conducted in the study group during 4 weeks, twice a week by the principal investigator at the study setting.
At the recruitment point muscle strength, quality of life and anthropometric measurements of all 40 participants will be measured, and after 4 weeks of introducing thera band exercises for the study group, the same parameters will be measured again among all participants.
Inclusion criteria
Patients with a history of myocardial infarction for more than 2 weeks
Male or female patients
Aged between 30-60 years
Patients who were subjected to coronary artery bypass graft (CABG) surgery more than 1 month ago
Exclusion criteria
Patients with uncontrolled hypertension (systolic blood pressure>180 mmHg and diastolic blood pressure >110mmHg)
Patients with unstable angina
Patients with hypertrophic cardiomyopathy
Severe orthopaedic conditions that would prohibit exercises
Patients who have an ejection fraction below 60%
Primary outcome(s)
|
1.
Muscle strength assessed by a hand held dynamometer |
[ At recruitment point and 4 weeks after introducing intervention ] |
|
2.
Height assessed using a stadiometer |
[ At recruitment point and 4 weeks after introducing intervention ] |
|
3.
Weight assessed using a weight scale |
[ At recruitment point and 4 weeks after introducing intervention ] |
|
4.
Waist, calf and mid upper arm circumference assessed stretch resistant tape |
[ At recruitment point and 4 weeks after introducing intervention ] |
|
5.
Quality of life assessed using WHOQOL questionnaire |
[ At recruitment point and 4 weeks after introducing intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
40 (20 in one arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-01-04
Anticipated end date
2021-02-24
Date of first enrollment
Date of study completion
Recruitment status
Withdrawn
Funding source
Self funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2020-07-16
Approval number
UCP/AL/16/350
Details of Ethics Review Committee
| Name: | Ethics Review Committee |
| Institutional Address: | Faculty of Medicine, University of Colombo |
| Telephone: | 0112695300 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
H.M.S.N.K.Ariyarathne
Undergraduate
Department of Allied Health Sciences, Faculty of Medicine, University of Colombo.
0713215210
medbspt16350@stu.cmb.ac.lk
Contact Person for Public Queries
Dr. Ranil Jayawardena
Senior lecturer
Department of physiology, Faculty of Medicine, University of Colombo.
0715960224
ranil7@gmail. Com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
