| CTRI Number |
CTRI/2017/10/009981 [Registered on: 03/10/2017] Trial Registered Prospectively |
| Last Modified On: |
03/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on recovery after heart surgery. |
|
Scientific Title of Study
|
Efficacy of yoga based cardiac rehabilitation on clinical outcomes in post CABG patients: 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 BALRAM AIRAN |
| Designation |
PROFESSOR AND HEAD (C.T.V.S., AIIMS) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
HOD OFFICE
7TH FLOOR
DEPARTMENT OF CTVS
CN CENTRE
AIIMS
NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
01126593862 |
| Fax |
|
| Email |
airanbalram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GAUTAM SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ROOM NO 12
PORTA CABIN
8TH FLOOR
DEPARTMENT OF CARDIOLOGY
CN CENTRE
AIIMS
NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
01126593862 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GAUTAM SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ROOM NO 12
PORTA CABIN
8TH FLOOR
DEPARTMENT OF CARDIOLOGY
CN CENTRE
AIIMS
NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
01126593862 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
| FUNDING AGENCY
MINISTRY OF AYUSH AND
INFRASTRUCTURAL SUPPORT BY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
MINISTRY OF AYUSH |
| Address |
Ministry of AYUSH, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110 023 |
| Type of Sponsor |
Government funding agency |
|
|
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 BALRAM AIRAN |
CENTRE FOR INTEGRATIVE MEDICINE AND RESEARCH |
CENTRE FOR INTEGRATIVE MEDICINE AND RESEARCH
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
NEW DELHI 110029
New Delhi
DELHI |
01126593862
airanbalram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics committee, AIIMS |
Approved |
| Ethics committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CORONARY ARTERY BYPASS GRAFTING(CABG), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
WITHOUT YOGA |
Conventional medical management (medical management which includes physiotherapy, life style modifications and medications) |
| Intervention |
YOGA |
Yoga+ conventional
medical management which includes physiotherapy, life style modifications and medications.
Yoga practices will be taught at AIIMS at baseline, 6 weeks, 3 months and 6 months. They will be encouraged to practice yoga as per the module every day at home till last follow -up visit(12 months). Compliance will be ensured telephonically and with the help of written log book. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing and able to participate
2. All adults between 35- 65 years of age
3. Patients established with double or triple vessel disease planned for elective CABG
d.Patients with uncomplicated peri-operative course, who are able to perform yoga |
|
| ExclusionCriteria |
| Details |
a. Emergency CABG
b. CABG with valve replacement surgeries
c. LVEF < 30%
d. Acute and Chronic renal failure with or
without dialysis
e. Regular yoga practitioners
f. Physical disabilities precluding yoga
practice.
g. Neuro-psychiatric illness
h. Patients already exposed to yoga |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Clinical outcomes
Risk factor control:
Blood pressure,Glycemic control-( hba1c),Lipid profile,Measurement of obesity-
Waist Hip Ratio and BMI,Physical activity- IPAQ
Neuropsychiatric outcomes:
Anxiety and depresion(Hospital Anxiety and depression Scale), Quality of life- (SF-36 QOL)
2.Rehabilitative outcomes-
Exercise capacity ( Modified Bruce potocol)
Pulmonary capacity (Pulmonary function test)
|
6 weeks, 3, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOMES
1. MACCE( major adverse cerebrovascular or cardiovascular events)
2. Inflammatory Markers- hs- CRP, IL-6, TNF-a
3. LV- Dysfunction- ECHO
4. Global gene expression |
6 weeks, 3, 6 and 12 months
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
10/10/2017 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be a randomized controlled trial which is being done to evaluate the long term efficacy of yoga as an adjunctive to conventional medical management on clinical outcomes in post CABG rehabilitation.A total 300 patients will be randomised into two groups ( 150 in experimental group and 150 in yoga group) based on inclusion and exclusion criteria. The Control Group: The control group will be administered conventional medical management ( which includes Physiotherapy, life style modifications and drugs ) post CABG. Study Group (Yoga Group): The study group / experimental group will get yoga intervention along with the conventional medical management which includes physiotherapy, life style modifications and medications.
Yoga group will receive supervised training of yoga at AIIMS for 6 weeks. After 6 weeks patients will be recommended to practice at home and the compliance to yoga will be ensured telephonically and through written log. They will be taught more yoga techniques during the 6th week and the 6th month of follow- up visits. Patients of both the groups will be physically followed- up and undergo repeat assessments at 6 weeks, 3, 6 and 12 month in terms of primary and secondary outcomes. |