Effect of modified and standard cardiac rehabilitation program on bio-psycho-physiological parameters among acute coronary syndrome patients at a tertiary care institute: a randomized controlled trial protocol

Background: Coronary artery disease (CAD) is a significant cause of mortality globally, with acute coronary syndrome (ACS) being a critical manifestation. Cardiac rehabilitation (CR) programs improve quality of life, reduce mortality, and enhance recovery post-acute events. This study aims to evaluate the effects of a modified CR program compared to the standard CR program on bio-psycho-physiological parameters in ACS patients including exploring the barriers to adherence to MCR. Methods: A randomized controlled trial will be conducted with 154 ACS patients at tertiary care institute. Participants will be allocated into experimental (modified CRP) and control (standard CRP) groups. The primary outcomes will include 6 min walk test (6MWT) and biological (lipid profile, HbA1c), physiological (BP, HR), and psychological (anxiety, depression, quality of life) parameters will be the secondary outcomes. Descriptive and inferential statistics will be employed to analyses the results, including an intention-to-treat (ITT) analysis to account for all participants as originally allocated. Qualitative data will be analyzed using thematic analysis with NVivo, identifying key barriers to modified cardiac rehabilitation through coding and theme development. Rigor will be maintained via member checking, peer debriefing, and audit trails to ensure credibility and trustworthiness. Conclusion: The findings aim to inform the development of evidence-based, culturally appropriate CR programs in India. Trial registration: CTRI/2024/12/078832