| CTRI Number |
CTRI/2021/05/033421 [Registered on: 06/05/2021] Trial Registered Prospectively |
| Last Modified On: |
28/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pedometer in Cardiac Rehabilitation |
|
Scientific Title of Study
|
Effect of Pedometer
based Exercise program
on Functional capacity
and Quality of Life in
Post CABG Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanamala Lakshmi Vasavi |
| Designation |
Post Graduate student |
| Affiliation |
Kasturba Medical college |
| Address |
Department of physiotherapy,
Kasturba medical college, Bejai, Mangaluru.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
vlvasavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Pratap Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical college |
| Address |
Department of Physiotherapy,
Kasturba medical college, bejai, Mangaluru.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
vijaypratap.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vanamala Lakshmi Vasavi |
| Designation |
Post graduate student |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of physiotherapy,
Kasturba Medical College, Bejai, Manguluru.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
vlvasavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy,
Kasturba Medical College, Bejai, Manguluru.
Manipal university |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Light house hill road
Mangalore
575001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vanamala Lakshmi Vasavi |
Kasturba medical college and hospital, mangalore |
Department of physiotherapy, 7th floor, KMC jyothi.
Dakshina Kannada
KARNATAKA |
8522964242
vlvasavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KASTURBA MEDICAL COLLEGE, MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEDOMETER |
Pedometer, a wearable device is given to the patient along with a pedometer based exercise program will be given to the patients. monitor the step count of the patients through pedometer for the next two weeks duration. |
| Comparator Agent |
Regular exercise program |
Regular exercises of the cardiac rehabilitation are given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone coronary artery bypass graft (CABG) surgery. |
|
| ExclusionCriteria |
| Details |
Patients with chronic heart failure, who cannot walk without assistive devices and have other orthopedic limitations. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional capacity
|
during discharge and after 2 weeks of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health related quality of life |
during discharge and after 2 weeks of discharge. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the use of pedometer based exercise program on functional capacity and quality of life in patients who have undergone CABG surgery. This trail is to understand the use of pedometer in assessing exercise capacity and therefore functional capacity have not been studied enough in India. It is an easy and handy tool to monitor exercise in Phase II subjects when they are at home.
HYPOTHESIS
Null hypothesis- there will be no difference due to pedometer-based exercise program on functional capacity and quality of life in patients who have undergone CABG surgery.
Alternate hypothesis- there will be difference due to pedometer-based exercise program on functional capacity and quality of life in patients who have undergone CABG surgery. |