| CTRI Number |
CTRI/2018/07/014713 [Registered on: 03/07/2018] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Feasibility of cardiac rehabilitation in patients who have undergone stent insertion |
|
Scientific Title of Study
|
Feasibility of implementing a cardiac rehabilitation algorithm in patients following percutaneous coronary intervention |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akhila Satyamurthy |
| Designation |
Post-graduate student |
| Affiliation |
Dept of Physiotherapy, SOAHS, MAHE |
| Address |
Department of Physiotherapy
School of Allied health Sciences, MAHE
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8105523279 |
| Fax |
|
| Email |
asmeenaakhila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Nivedita S Prabhu |
| Designation |
Assistant Professor (senior scale) |
| Affiliation |
Dept of Physiotherapy, SOAHS, MAHE |
| Address |
Department of Physiotherapy
School of Allied health Sciences, MAHE
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8105523279 |
| Fax |
|
| Email |
nivedita.kamath83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akhila Satyamurthy |
| Designation |
Post-graduate student |
| Affiliation |
Dept of Physiotherapy, SOAHS, MAHE |
| Address |
Department of Physiotherapy
School of Allied health Sciences, MAHE
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8105523279 |
| Fax |
|
| Email |
asmeenaakhila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Dept of Cardiology
Unit I
Kasturba 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 |
| Akhila Satyamurthy |
Kasturba Hospital |
Dept of Cardiology
Unit I
Udupi
KARNATAKA |
8105523297
asmeenaakhila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
patients with myocardial infarction who have undergone percutaneous coronary intervention, (1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CARDIAC REHABILITATION |
phase I includes patient tolerated exercise comprising of breathing exercise, active movements of upper limb and lower limb, walking and stair climbing. All the exercises will be progressed based on patients symptoms and clinical values. On the day of discharge a six-minute walk test will be performed and will be made to answer the questionairres. Patient will be given home exercise program comprising of the above exercises. Progression will be done every week and followed up through telephone.
After 1 month patient will be re-assessed for their symptoms,functional capacity through six-minute walk test and will be asked to answer the same questionairre. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients who have undergone percutaneous coronary intervention (PCI) |
|
| ExclusionCriteria |
| Details |
NYHA class IV
Haemodynamically unstable
Unstable angina
Uncompensated heart failure
Significant aortic stenosis
Orthostatic hypotension
Active pericarditis and myocarditis
Uncontrolled arrythmias
Acute pulmonary embolism
Ejection fraction less than 20%
Hypertrophic cardiomyopathy
Recent stroke or transient ischemic attack (TIA)
Palpitation, lethargy and dizziness
Severe psychological disturbances
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Feasibility metrics:
1. Process metrics-Refusal rates, referral rates and recruitment rates
2. Resource metrics-time of treatment, adherence rate, dropout rate, length of hospital stay
3. Management metrics-Adverse effects and clinical emergencies
4. Scientific metrics-response of the study (clinical measures, six-minute walk test, TAMPA heart of kinesophobia, cardiac depression scale, cardiac self-efficacy scale, WHOQOL-BREF) |
Feasibility metrics:
1. Process metrics- at the beginning and end of the study
2. Resource metrics-at the start and end of the study
3. Management metrics- at the end of the study
4. Scientific metrics-at the start of the study, on the day of discharge and at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| six minute walk test, cardiac depression scale, cardiac self-efficacy scale, TAMPA scale of Kinesophobia Heart, WHOQOL-BREF questionnairres |
on the day of discharge and the end of the study (after 30 days) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/07/2018 |
| Date of Study Completion (India) |
29/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- National data from a global survey of ICCPR identified cardiac rehabilitation density to be a median of 18. Of which India was found to be 360, ranking 85 out of 111 countries that participated in the global survey. [Turk-Adwai K, Supervia M, Lopez-Jimines F et al. Global cardiac rehabilitation availability, volumes, capacity and density. Lancet 2018 (under review)]. This shows the under-utilization of cardiac rehabilitation in India. With the growing burden of cardiovascular diseases and cardiac rehabilitation being the class IA recommendation, various cardiac rehabilitation models, especially for low resource settings, have been proposed. Thus, this study aims to test the feasibility of a cardiac rehabilitation algorithm based on feasibility metrics. Feasibility ensures effective implementation, of which studies are lacking. Cardiac rehabilitation algorithm shall be given to 30 patients who have undergone percutaneous coronary intervention. This includes early phase exercises followed by a home exercise program with weekly progression and telephonic follow-up. The feasibility shall be tested based on process metrics, resource metrics, management metrics and scientific metrics. Based on pre-defined criteria, the conclusion on the feasibility of the algorithm will be drawn
|