Protocol for a feasibility randomized controlled trial of gentle yoga in older patients discharged from phase II cardiac rehabilitation

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-06-04 DOI:10.1016/j.conctc.2024.101320

Geunyeong Cha , Misook L. Chung , Nicholas R. Heebner , Ulf G. Bronas , Martha J. Biddle , Chin-Yen Lin , JungHee Kang , Jia-Rong Wu , Jessica H. Thompson , Ashmita Thapa , Debra K. Moser

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Abstract

Background

Physical activity (PA) is essential following an acute cardiac event. Cardiac rehabilitation (CR) is commonly prescribed, and PA after CR is recommended. Because of age-related changes in functional ability and multi-comorbidity, many older cardiac patients struggle to continue performing PA at home after CR. Depressive symptoms and anxiety are prevalent in cardiac patients and associated with poor self-care, including lack of daily PA. Yoga has been demonstrated to improve psychological and physical health outcomes in cardiac patients, but it is unknown whether yoga, modified for older CR patients – Gentle Yoga – is beneficial in managing psychological distress and maintaining PA following phase II CR. Our specific aims are to:1) determine the feasibility and acceptability of a modified gentle yoga intervention delivered via video conferencing for older cardiac patients; 2) compare, at 3-month follow-up, the effects and determine effect sizes of a gentle yoga intervention versus control on psychological health and physical health.

Methods

We are conducting a 2-group (intervention versus control) randomized controlled pilot study. The intervention is a 12-week gentle yoga program delivered via video conference. Short-term effects will be evaluated at 3-month.

Conclusion

This study is designed to be suited for older cardiac patients who would not have access to supervised PA opportunities after facility-based CR to enhance PA. This study will provide data about the feasibility and acceptability of the protocol for older cardiac patients and will offer effect sizes to determine sample size for a fully powered randomized controlled trial.

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针对从第二阶段心脏康复出院的老年患者开展的轻柔瑜伽可行性随机对照试验方案

背景急性心脏事件发生后，体力活动（PA）至关重要。心脏康复（CR）是常见的处方，建议在心脏康复后进行体力活动。由于与年龄相关的功能变化和多病并发症，许多老年心脏病患者在心脏康复后难以在家中继续进行体力活动。心脏病患者普遍存在抑郁症状和焦虑，这与自我护理能力差有关，包括缺乏日常 PA。瑜伽已被证明能改善心脏病患者的心理和生理健康状况，但针对老年 CR 患者改良的瑜伽--轻柔瑜伽--是否能在第二阶段 CR 后对控制心理压力和维持 PA 有益，目前还不得而知。我们的具体目标是：1）确定通过视频会议为老年心脏病患者提供改良的温和瑜伽干预的可行性和可接受性；2）在 3 个月的随访中，比较温和瑜伽干预与对照对心理健康和身体健康的影响，并确定影响大小。干预措施是通过视频会议进行的为期 12 周的温和瑜伽课程。结论这项研究的目的是为老年心脏病患者设计的，因为他们在以医院为基础的康复治疗后无法获得有监督的体育锻炼机会，以加强体育锻炼。这项研究将为老年心脏病患者提供有关该方案的可行性和可接受性的数据，并将提供效应大小，以确定全面随机对照试验的样本大小。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.