Feasibility of cardiac rehabilitation in patients who have undergone stent insertion

Phase 1

Completed

Conditions: Subsequent ST elevation (STEMI) myocardial infarction of unspecified site,

Registration Number: CTRI/2018/07/014713

Lead Sponsor: Kasturba Hospital

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

patients who have undergone percutaneous coronary intervention (PCI).

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Process metrics-Refusal rates, referral rates and recruitment rates	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
Feasibility metrics:	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
2. Resource metrics-time of treatment, adherence rate, dropout rate, length of hospital stay	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
3. Management metrics-Adverse effects and clinical emergencies	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
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 Measures

Name	Time	Method
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)

Trial Locations

Locations (1): Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Akhila Satyamurthy
Principal investigator
8105523297
asmeenaakhila@gmail.com