| CTRI Number |
CTRI/2021/03/032270 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
23/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of post operative physiotherapy in patients to improve cardiovascular endurance
|
|
Scientific Title of Study
|
Effect of post operative physiotherapy in patients following CABG to improve cardiovascular endurance - A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Patel |
| Designation |
Tutor |
| Affiliation |
Nootan College of Physiotherapy Sankalchand Patel University |
| Address |
OPD 6, Cardiovascular Department, Nootan College of Physiotherapy
OPD 6, Cardiovascular Department, Nootan College of Physiotherapy
Mahesana
GUJARAT
384315
India |
| Phone |
9624692121 |
| Fax |
384315 |
| Email |
dr.srp12345.sp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Patel |
| Designation |
Tutor |
| Affiliation |
Nootan College of Physiotherapy Sankalchand Patel University |
| Address |
OPD 6, Cardiovascular Department , Nootan College of Physiotherapy
OPD 6, Cardiovascular Department , Nootan College of Physiotherapy
Mahesana
GUJARAT
384315
India |
| Phone |
9624692121 |
| Fax |
384315 |
| Email |
dr.srp12345.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Patel |
| Designation |
Tutor |
| Affiliation |
Nootan College of Physiotherapy Sankalchand Patel University |
| Address |
OPD 6, Cardiovascular Department , Nootan College of Physiotherapy
OPD 6, CardiovascularDepartment , Nootan College of Physiotherapy
Mahesana
GUJARAT
384315
India |
| Phone |
9624692121 |
| Fax |
384315 |
| Email |
dr.srp12345.sp@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD Nootan College of Physiotherapy S.K. University visnagar |
|
|
Primary Sponsor
|
| Name |
Priyal Kansara |
| Address |
sankadi sheri ambaji mata ni khadaki visnagar |
| 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 |
| Priyal Kansara |
Nootan College of Physiotherapy Sankalchand Patel University Visnagar |
OPD 6 Cardiovascular Department
Mahesana
GUJARAT |
9624760204
384315
priyal.kansara1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee nootan college of physiotherapy Sankalchand Patel University Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I707||Atherosclerosis of other type of bypass graft(s) of the extremities, (2) ICD-10 Condition: Z951||Presence of aortocoronary bypass graft, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercise
Breathing Exercise
Resistive Exercise |
DURATION: 30 to 35 min for each session. 6 session/week for 3 weeks.
PROTOCOL: -
Week -1:
Warm up exercise (5 min) - Slow walking
Resistive training (10 min) – Upper and lower extremity with weight (500 gm)
Aerobics (10 min.)- Treadmill walk (speed – 2.5 mph)
Cool down (5 min.) - Gentle body movement
Ventilatory muscle training – Diaphragmatic exercise & pursed lip exercise and incentive spirometry
Week -2: -
Warm up exercise (5 min) - Slow walking
Resistive training (10 min) – Upper and lower extremity with weight (1 kg)
Aerobics (10 min.)- Jogging
Cool down (5 min.) - Gentle body movement
Ventilatory muscle training – Diaphragmatic exercise & pursed lip exercise and incentive spirometry
Week –3: -
Warm up exercise (5 min) - Slow walking
Resistive training 10 min Upper and lower extremity with weight 1.5 kg Aerobics 10 min Static cycling
Cool down 5 min Gentle body movement
Ventilatory muscle training Diaphragmatic exercise& pursed lip exercise and incentive spirometry |
| Comparator Agent |
Aerobic Exercise
Breathing Exercise |
DURATION: 30 to 35 min for each session. 6 session/week for 3 weeks.
PROTOCOL: -
Week -1:
Warm up exercise (5 min) - Slow walking
Resistive training (10 min) – Upper and lower extremity with weight (500 gm)
Aerobics (10 min.)- Treadmill walk (speed – 2.5 mph)
Cool down (5 min.) - Gentle body movement
Ventilatory muscle training – Diaphragmatic exercise & pursed lip exercise and incentive spirometry
Week -2: -
Warm up exercise (5 min) - Slow walking
Resistive training (10 min) – Upper and lower extremity with weight (1 kg)
Aerobics (10 min.)- Jogging
Cool down (5 min.) - Gentle body movement
Ventilatory muscle training |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient age group 40 to 70
study participants with no other involvement
patient of male and female |
|
| ExclusionCriteria |
| Details |
study participants with lower limb injury like traumatic injury
study participants with any neurological and psychological abnormalities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
6 minute walk test
Borg Scale |
3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/04/2021 |
| 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="21"
Months="2"
Days="18" |
|
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
|
TITLE : Effect of post operative physiotherapy in patients with CABG to improve cardiovascular endurance - A Randomized controlled trial
AIM : To study the effect of post -operative physiotherapy in patient with CABG to improve cardiovascular endurance
OBJECTIVE : To increase Aerobic capacity To improve exercise tolerance and cardiovascular endurance To improve breathing capacity
|