| CTRI Number |
CTRI/2008/091/000298 [Registered on: 27/05/2009] |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Cardiac rehabilitation and quality of life in congestive heart failure |
|
Scientific Title of Study
|
The effects of exercise based cardiac rehabilitation on quality of life in congestive heart failure
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Abraham Samuel Babu |
| Designation |
Postgraduate |
| Affiliation |
Manipal University |
| Address |
Department of physiotherapy
MCOAHS
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
abrahambabu@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Abraham Samuel Babu |
| Designation |
postgraduate |
| Affiliation |
Manipal University |
| Address |
Department of physiotherapy,
MCOAHS
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
abrahambabu@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Abraham Samuel Babu |
| Designation |
|
| Affiliation |
|
| Address |
Department of physiotherapy
MCOAHS
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
abrahambabu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abraham Samuel Babu |
Manipal |
Department of physiotherapy, MCOAHS,
Udupi
KARNATAKA |
9742502838
abrahambabu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Katurba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Congestive heart failure, (1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Exercise based cardiac rehabilitation |
Supervised 5-step progression of exercises and supervised ambulation in hospital at moderate intensity upto patients tolerance. |
| Comparator Agent |
Regular treatment |
Physician directed ambulation and advice on physical activity in hospital and at discharge |
| Intervention |
Structured home program |
Structured home program and walking individualised for each patient at moderate intensity upto patients tolerance |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
50-80years
NYHA Class II - IV heart failure |
|
| ExclusionCriteria |
| Details |
Severely disabling orthopaedic and neurological problems
Obstructive cardiomyopathy
Stenotic valvular diseases
Uncontrolled ventricular tachyarrhythmia
Absence of an implantable cardioverter-defibrillator despite a history of sudden cardiac death
Acute renal failure
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SF-36 |
Admission, discharge and 8 weeks follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minnesota Living With Heart Failure Questioannaire |
Admission, discharge and 8 weeks follow up |
| Six minute walk test |
Discharge and 8 weeks follow up |
|
Target Sample Size
Modification(s)
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/05/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Babu AS, Maiya AG, George MM, R Padmakumar. The benefits of exercise based cardiac rehabilitation in congestive heart failure: A case series. Indian Heart J 2009;61:536 (Abstract)
AS Babu, AG Maiya, MM Geroge, R Padmakumar, V Gudattu. Effects of exercise based cardiac rehabilitation on quality of life in heart failure with reduced ejection fraction. J HK Coll Cardiol 2010;18 (suppl 1):A5 (Abstract) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized control trial to test the efficacy of a supervised phase-1 cardiac rehabilitation program followed by a 6 week structured home program on quality of life in patients with congestive heart failure (CHF). All patients admitted with class II-IV NYHA functional classification of CHF will be included. Random allocation through concealed allotment using block randomization will be carried out. Outcomes will be measured at admission, discharge and follow-up. The primary outcome will be the SF-36 while the secondary outcome measures will be the Minnesotta living with heart failure questionnaire and the six minute walk test. Follow up will be done in the experimental group weekly over the phone. At the end of 6 weeks, both groups will be reviewed and all the outcome measures measured. |