| CTRI Number |
CTRI/2022/07/044295 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| 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 cycle ergometer in phase - I cardiac rehabilitation |
|
Scientific Title of Study
|
Effect of cycle ergometer on functional capacity and pulmonary function in phase - I cardiac rehabilitation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jigar Mehta |
| Designation |
Associate Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy, Shree Krishna Hospital,
Karamsad K M Patel Institute of Physiotherapy, Shree Krishna
Hospital, Karamsad
Anand
GUJARAT
388325
Anand
GUJARAT
388325
India |
| Phone |
9824771843 |
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigar Mehta |
| Designation |
Associate Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy, Shree Krishna Hospital,
Karamsad K M Patel Institute of Physiotherapy, Shree Krishna
Hospital, Karamsad
Anand
GUJARAT
388325
Anand
GUJARAT
388325
India |
| Phone |
9824771843 |
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Kinjal Rathod |
| Designation |
PG Student |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy, Shree Krishna Hospital,
Karamsad K M Patel Institute of Physiotherapy, Shree Krishna
Hospital, Karamsad
Anand
GUJARAT
388325
Anand
GUJARAT
388325
India |
| Phone |
8488038448 |
| Fax |
|
| Email |
kinjalbr@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| K M Patel Institute of Physiotherapy, Shree Krishna Hospital, Karamsad |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [ Self] |
|
|
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 |
| Dr Jigar Mehta |
B M Patel Cardiac centre, Karamsad |
K M Patel Institute of
Physiotherapy, Shree
Krishna Hospital,
Karamsad, Anand,
Gujarat- 388325
Anand
GUJARAT
Anand
GUJARAT |
9824771843
jigarnm@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - 2, Bhaikaka University, Karamsad, Anand, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cycle ergometer in phase -I cardiac rehabilitation. |
3rd post-operative day 5 min of cycle ergometer will be given and according to patient tolerance and vital stability duration will be compared to conventional group |
| Intervention |
cycle ergometer in phase -I cardiac rehabilitation. |
This interventional study use of cycle ergometer in acute cardiac rehabilitation. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
operated case of coronary artery bypass graft(CABG). |
|
| ExclusionCriteria |
| Details |
1.Mechanical ventilation more than 24 hours
2. Musculoskeletal, neurological and peripheral vascular impairment
3. known case of respiratory diseases
4. left main coronary artery stenosis
5. ejection fraction less than 30 %
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. 6 Minute Walk Test(6MWT) |
pre operative before intervention and at time of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Maximum inspiratory pressure
2.chest expansion |
pre operative before intervention and at time of discharge. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is going to be conducted on post operative coronary artery bypass grafting(CABG) in Phase -I. as being a experimental study we were going to see effect of cycle ergometer in this specific population in early post operative period. In this study two group ( control group and experimental group).control group will receive conventional therapy include General mobility Exercises, Breathing Exercises, huffing and coughing
techniques, DVT prophylaxis, Incentive spirometry, bed side mobility and experimental group receive cycle ergometer along with conventional therapy. Cycle ergometer start at post operative day 3rd for 5 min and duration will be progress according to patient tolerance and vitals stability. During the
study participant will be having any clinical symptoms or discomfort then
he/she will be excluded from study and inform consultant for same. outcome measurements were taken at pre operative day and at the day of discharge. |