| CTRI Number |
CTRI/2024/03/064448 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exercises on heart rate, exercise capacity and quality of life in heart failure patients. |
|
Scientific Title of Study
|
Effect of exercise based cardiac rehabilitation on heart rate variability, functional exercise capacity and quality of life in patients with heart failure. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSRMC/EC/AP-03/11-2023 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veena Kiran Nambiar |
| Designation |
Professor |
| Affiliation |
|
| Address |
M.S.Ramaiah medical college,
dept. of physiotherapy,
new BEL road, MSRIT post,
MSR nagar, bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
veenakiran_nambiar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Kiran Nambiar |
| Designation |
Professor |
| Affiliation |
Ramaiah Medical College |
| Address |
M.S.Ramaiah medical college,
dept. of physiotherapy,
new BEL road, MSRIT post,
MSR nagar, bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
|
| Email |
veenakiran_nambiar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Veena Kiran Nambiar |
| Designation |
Professor |
| Affiliation |
Ramaiah Medical College |
| Address |
M.S.Ramaiah medical college,
dept. of physiotherapy,
new BEL road, MSRIT post,
MSR nagar, bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
|
| Email |
veenakiran_nambiar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah University of Applied Sciences |
|
|
Primary Sponsor
|
| Name |
Ramaiah University of Applied Sciences |
| Address |
New BEL Road, Bengaluru |
| 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 |
| Veena Kiran Nambiar |
Ramaiah memorial Hospital |
New BEL Road
Bangalore
KARNATAKA |
9880575407
veenakirannambiar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I428||Other cardiomyopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
regular counselling and home program |
| Intervention |
Standard care with structures exercise protocol |
Cardiac Rehabilitation Protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
 Males and Females aged above 18 years.
 Left ventricular ejection fraction < 40% (Assessed by 2D Echo) by Simpson’s method.
 Patients diagnosed with NYHA Class II and III Heart failure within 6 months
|
|
| ExclusionCriteria |
| Details |
 Presence of any other diseases limiting life expectancy
 Severe valvular diseases
 Class IV HF
 Recurrent ventricular arrythmias
 End stage renal and liver disease
 Subjects already involved in any form of exercise training programs or clinical trials.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| : HRV, functional capacity (using 6MWD) and QOL (Kansas City Cardiomyopathy Questionnaire (KCCQ)) |
: HRV, functional capacity (using 6MWD) and QOL (Kansas City Cardiomyopathy Questionnaire (KCCQ)) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [veenakirannambiar6@gmail.com].
- For how long will this data be available start date provided 19-11-2025 and end date provided 19-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cardiovascular diseases are the leading cause of death and disability in India. Marked reduction in exercise capacity has detrimental effects on activities of daily living, health-related quality of life. This leads to increased risk of mortality and hospital admission rate is high following a heart failure (HF), which may be due to gaps in secondary prevention in general and a lack of cardiac rehabilitation (CR) services in particular. Numerous cardiac rehabilitation studies have demonstrated functional benefits, improvement in quality of life, and clinical outcomes from exercise training in patients with heart failure. Autonomic dysfunction is an independent predictor of cardiovascular disease and mortality after heart failure. Heart rate variability (HRV) is a widely used, easy, non-invasive method that is reproducible and cost-effective for estimating cardiac autonomic modulation. A depressed HRV is a valuable indicator of autonomic dysfunction. Depressed HRV suggests poor functioning of cardiac autonomic modulation and thus impaired ability of the heart to adapt to a range of physiological and environmental stimuli. Low heart rate variability (HRV) is an indicator of increased risk of sudden cardiac death in patients with chronic heart failure. |