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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

16 Oct 2020

The date of last modification

Oct 16, 2020



Application Summary


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


Trial Details


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

  1. Patients with a history of myocardial infarction for more than 2 weeks

  2. Male or female patients

  3. Aged between 30-60 years

  4. Patients who were subjected to coronary artery bypass graft (CABG) surgery more than 1 month ago


Exclusion criteria

  1. Patients with uncontrolled hypertension (systolic blood pressure>180 mmHg and diastolic blood pressure >110mmHg)

  2. Patients with unstable angina

  3. Patients with hypertrophic cardiomyopathy

  4. Severe orthopaedic conditions that would prohibit exercises

  5. 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

Pending


Funding source

Self funded


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

BSc. Physiotherapy Degree Programme

Department of Allied Health Sciences, Faculty of Medicine, University of Colombo.
0112688695


Secondary study sponsor (If any)

None





Trial Completion details


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