| CTRI Number |
CTRI/2018/06/014363 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of selected yoga therapy on improvement of quality of life and heart function in heart failure patients on regular medications |
|
Scientific Title of Study
|
Effect of selected yoga therapy on quality of life and functional outcome in heart failure patients on optimal medical management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sridevi Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
Department of Cardiovascular Technology, SOAHS, Manipal
Department of Cardiovascular Technology, SOAHS, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevisanthosh2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sridevi Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
Department of Cardiovascular Technology, SOAHS, Manipal
Department of Cardiovascular Technology, SOAHS, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevisanthosh2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sridevi Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
Department of Cardiovascular Technology, SOAHS, Manipal
Department of Cardiovascular Technology, SOAHS, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevisanthosh2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, Kasturba Medical College & Hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Department of Cardiology Kasturba Medical College and Hospital Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sridevi |
Kasturba hospital Manipal |
Dept of Cardiology
Room No 34 3rd floor OPD block Manipal
Udupi
KARNATAKA |
8867902764
sridevisanthosh2013@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comitteemanipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Heart Failure with optimal medical management , (1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
without Yoga Therapy |
Heart Failure patients on medication |
| Intervention |
yoga therapy |
Heart Failure patients on medication
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give consent
2.Heart failure NYHA class less than or equal to III
3.Patient already on guideline directed optimal medical therapy and underwent coronary intervention/revascularization or device therapy> 6 months
4.LVEF less than 45%
|
|
| ExclusionCriteria |
| Details |
1.Moderate or severe mitral valve disease (Mitral stenosis)
2.Moderate or severe aortic valve disease
3.Patients with decompensated heart failure
4.Patients with severe lung disease
5.Life expectancy < one year
6.End organ dysfunction
7.Liver failure
8.Severe cognitive dysfunction
9.Patients with neurological disorders like hemiplegia, paraplegia or stroke.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Yoga therapy may benefit in terms of improvement in quality of life and left ventricular function among heart failure patients who are on guideline directed optimal medical therapy. |
1 year of followup |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| left ventricular ejection fraction |
1 year of followup |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
29/06/2018 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cardiac patients who are on heart failure treatment and who underwent coronary intervention or bypass graft surgery and still they present heart failure symptoms even after 6 months, such patients are enrolled to participate in the present proposed study. This group is considered as interventional group and the same age match group is considered as non-interventional group.If subjects are willing to give consent to participate in the study the parameters required for the study is documented. The participants will be guided to different yoga therapeutic modules and cardiac function during follow-up will be assessed. we perform echocardiographic examination to evaluate ventricular function status at 1 month, 3 month, 6 month and 1 year of follow-up. |