Title of the study: Developing a Model for Delivery of Long-Term Cardiac Rehabilitation: An Experimental Study

Background and Rationale:

Research supports the benefits of CR, which shows that it enhances cardiovascular endurance, muscular strength, and mental health. Researching PHC-based CR could make rehabilitation more accessible to less fortunate groups. The relative benefits of tertiary care over PHC-based CR can impact healthcare policy and resource allocation. Effect over Time: Evaluating long-term outcomes ensures continued benefits and adherence to lifestyle changes. 

Cardiac rehabilitation is a key component in maintaining and improving outcomes for patients with ischemic heart disease. The effectiveness of various delivery modalities, including tertiary care hospital-based and primary health care-based, remains uncertain. Each technique may offer unique benefits and challenges in terms of increasing important health indices such as cardiovascular endurance, physical strength and mobility, cognitive functioning, mental well-being, and overall quality of life. The uncertainty around the comparative efficacy of various treatments makes it difficult for healthcare practitioners to establish optimal rehabilitation programs that are tailored to the needs of patients and available resources. Addressing this knowledge gap is crucial for improving patient care.

This research can prove that Cardiac rehabilitation (CR) is a critical component of long-term management for patients with ischemic heart disease (IHD), as it addresses both physical and mental well-being. However, traditional CR models delivered through tertiary care hospitals often face challenges related to accessibility, affordability, and convenience, particularly for patients in rural or resource-limited settings. Exploring and comparing alternative CR delivery models, such as primary health care-based and home-based CR, holds great clinical significance.

Aim: To develop a model of care for the delivery of long-term cardiac rehabilitation and to study the efficacy of PHC-based CR compared to tertiary care CR in terms of outcomes such as cardiovascular endurance, muscle strength and mobility, cognition, mental health, and quality of life in patients with IHD.

Objective 1- To evaluate the effect of tertiary care hospital-based cardiac rehabilitation on cardiovascular endurance, muscle strength, mobility, cognition, mental health, and overall quality of life in patients with ischemic heart disease (IHD).

 ii. Objective 2- To evaluate the effect of primary health care-based cardiac rehabilitation on the cognitive, cardiovascular endurance, muscle strength and mobility, mental health, and quality of 6 life in patients with IHD.

iii. Objective 3: To compare the effects of CR delivered at PHC and a tertiary care hospital on cognitive, cardiovascular endurance, muscle strength, mobility, mental health, and quality of life in patients with IHD.

 iv. Objective 4: To propose a patient-centric model of care for long-term of CR to optimize functioning in patients with IHD.

Study Design: Experimental study design

METHOD: Plan of Study: Stepwise Methodology: Ethical Approval: Obtain ethical approval from the ethical committee of MGMIHS to ensure compliance with ethical standards. Screening Participants: Identify individuals aged 40–70 diagnosed with Ischemic Heart Disease (IHD), either managed medically or surgically (PTCA/CABG), who have been stable for at least two weeks. Written Consent: Written consent will be obtained from participants who meet the inclusion criteria. Provide an adequate explanation of the study procedure to participants to ensure informed consent. Pre-cardiac rehabilitation (CR) Assessment: Collect baseline scores for participants using the following tools and measures:

Participants:

Inclusion Criteria:

 a. Males and females in the age group 40-70 years

 b. Diagnosed with IHD, managed medically or surgically –PTCA/CABG, stable for at least 2 weeks.

 c. Patients in phase II and phase III cardiac rehabilitation.

 Exclusion Criteria:

a. Any medical red flags

b. Acutely unstable patients with cardiovascular diseases

c. Acute infective pathology

 d. Neurological condition

 e. Non-cooperative patients

f. Unstable psychological condition

g. Who is not willing to participate in the study?

Outcomes:

 1. Duke Activity Status Index

2. Mental Health Quality of Life questionnaire (MHQoL)

3. SF 36 Questionnaire

4. Tampa Kinesiophobia Questionnaire

5. Global Physical Activity Questionnaire

6. Hand grip strength using a dynamometer (in kg)

7. Sit-to-Stand test repetition count

 8. Y balance test distance score

9. 6-Minute Walk Test distance

10. Sit-and-reach test distance for flexibility

11. Blood pressure

 12. Heart rate

13. SpO2 levels

14. Body composition measures (BMI and waist-hip ratio)

Implementation of Cardiac Rehabilitation (CR) Protocol: Conduction of Cardiac Rehabilitation (CR) by international guidelines, AACVPR guidelines for exercise prescription, including the WHO PIR recommendations for IHD. 6. Post-Implementation Assessments: At 6 Weeks: Reassess all participants using the same outcome measures listed above. At 12 Weeks: Measure participants’ scores again using the same tools for consistency.

Intervention and Comparator: Implementation of Cardiac Rehabilitation: Intervention Group A (Control Group): will undergo Tertiary Hospital-Based Cardiac Rehabilitation in outpatient departments. This involves early supervised exercise sessions at tertiary hospitals’ outpatient departments, with multidisciplinary care and patient education. Participants receive conventional Cardiac Rehabilitation (CR) two to five times per week for 12 weeks. Group B (Experimental Group): will undergo Primary Health Care-Based CR Phase III Cardiac Rehabilitation (Long-term maintenance of a Healthy lifestyle Phase) - Community-level sessions conducted at primary care centers with periodic specialist visits. Standardization: Uniformity of exercise regimens across both groups (e.g., duration, intensity, frequency of sessions) will be ensured. All participants will be provided education on lifestyle changes, medication adherence, and dietary modifications. 9. Monitoring and Adherence:

Regular Follow-Ups: Biweekly check-ins will be used to monitor progress and address concerns. Adherence Tracking: Participants will be asked to maintain exercise logs for attendance in hospital or primary care sessions. Participant Support: Counseling or motivation sessions will be provided once a month to improve compliance. 10.

Outcome Assessment all outcome measures will be assessed at Post 6 weeks and 12 weeks of CR.

Data Collection: All the standardized procedures for collecting and recording data will be followed.

Data Analysis: Data will be entered in Microsoft Excel and will be kept ready for further statistical procedures. Follow-up will be maintained for 6 months after the completion of the study.

Ethical Consideration: Ethical approval given by the Ethics Committee for research on human subjects, MGMIHS, 3rd Floor, Sector 9, Kamothe, Navi, Mumbai.

Written consent will be obtained from participants who meet the inclusion criteria. Provide an adequate explanation of the study procedure to participants to ensure informed consent.

 Trial Registration Justification: The Trial will be registered before registering any participants, in compliance with CTRI norms.