Key result
Modified cardiac rehabilitation trial evaluates 6MWT performance versus standard care in ACS.
Why the study?
Cardiac rehabilitation improves outcomes post-acute events, but the comparative effects of a modified versus standard program on bio-psycho-physiological parameters in ACS patients, and barriers to adherence, need evaluation.
Does a modified cardiac rehabilitation program improve 6-minute walk test performance and bio-psycho-physiological parameters in acute coronary syndrome patients compared to a standard program?
RCT (n=154)
Single-blind (independent researcher overseeing randomization)
Computer-generated randomization sequence (1:1 ratio)
No
Does a modified cardiac rehabilitation program improve 6-minute walk test performance and bio-psycho-physiological parameters in acute coronary syndrome patients compared to a standard program?
This protocol outlines a randomized controlled trial to evaluate whether a modified cardiac rehabilitation program improves functional and bio-psycho-physiological outcomes in Indian patients with acute coronary syndrome.
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
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Sharma et al. (2025) conducted an RCT in Acute coronary syndrome (ACS) (n=154). Modified cardiac rehabilitation program vs. Standard cardiac rehabilitation program was evaluated on 6-minute walk test (6MWT). A modified cardiac rehabilitation program will be evaluated against standard care for its effects on the 6-minute walk test and bio-psycho-physiological parameters in 154 patients with acute coronary syndrome.
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