Protocol for a Feasibility Randomized Controlled Trial of Gentle Yoga in Older Patients Discharged from Phase II Cardiac Rehabilitation

Overview

Journal Contemp Clin Trials Commun

Date 2024 Jul 1

PMID 38947983

Authors

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

Affiliations

Soon will be listed here.

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.

References

Cain K, Conway T, Adams M, Husak L, Sallis J . Comparison of older and newer generations of ActiGraph accelerometers with the normal filter and the low frequency extension. Int J Behav Nutr Phys Act. 2013; 10:51. PMC: 3641979. DOI: 10.1186/1479-5868-10-51. View

Bell S, Schnelle J, Nwosu S, Schildcrout J, Goggins K, Cawthon C . Development of a multivariable model to predict vulnerability in older American patients hospitalised with cardiovascular disease. BMJ Open. 2015; 5(8):e008122. PMC: 4554894. DOI: 10.1136/bmjopen-2015-008122. View

Flint K, Pastva A, Reeves G . Cardiac Rehabilitation in Older Adults with Heart Failure: Fitting a Square Peg in a Round Hole. Clin Geriatr Med. 2019; 35(4):517-526. PMC: 6760316. DOI: 10.1016/j.cger.2019.07.008. View

Nunan D, Donovan G, Jakovljevic D, Hodges L, Sandercock G, Brodie D . Validity and reliability of short-term heart-rate variability from the Polar S810. Med Sci Sports Exerc. 2008; 41(1):243-50. DOI: 10.1249/MSS.0b013e318184a4b1. View

Portz J, Waddington E, Atler K, Van Puymbroeck M, Schmid A . Self-Management and Yoga for Older Adults with Chronic Stroke: A Mixed-Methods Study of Physical Fitness and Physical Activity. Clin Gerontol. 2017; 41(4):374-381. DOI: 10.1080/07317115.2016.1252453. View

Faul F, Erdfelder E, Buchner A, Lang A . Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009; 41(4):1149-60. DOI: 10.3758/BRM.41.4.1149. View

Levin C, Swoap S . The impact of deep breathing and alternate nostril breathing on heart rate variability: a human physiology laboratory. Adv Physiol Educ. 2019; 43(3):270-276. DOI: 10.1152/advan.00019.2019. View

Arrigo I, Brunner-LaRocca H, Lefkovits M, Pfisterer M, Hoffmann A . Comparative outcome one year after formal cardiac rehabilitation: the effects of a randomized intervention to improve exercise adherence. Eur J Cardiovasc Prev Rehabil. 2008; 15(3):306-11. DOI: 10.1097/HJR.0b013e3282f40e01. View

Staniute M, Brozaitiene J, Bunevicius R . Effects of social support and stressful life events on health-related quality of life in coronary artery disease patients. J Cardiovasc Nurs. 2011; 28(1):83-9. DOI: 10.1097/JCN.0b013e318233e69d. View

10.

Mohile S, Bylow K, Dale W, Dignam J, Martin K, Petrylak D . A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation. Cancer. 2007; 109(4):802-10. DOI: 10.1002/cncr.22495. View

11.

Su J, Yu D . Effectiveness of eHealth cardiac rehabilitation on health outcomes of coronary heart disease patients: a randomized controlled trial protocol. BMC Cardiovasc Disord. 2019; 19(1):274. PMC: 6884828. DOI: 10.1186/s12872-019-1262-5. View

12.

Cherup N, Strand K, Lucchi L, Wooten S, Luca C, Signorile J . Yoga Meditation Enhances Proprioception and Balance in Individuals Diagnosed With Parkinson's Disease. Percept Mot Skills. 2020; 128(1):304-323. DOI: 10.1177/0031512520945085. View

13.

Tao D, Xie L, Wang T, Wang T . A meta-analysis of the use of electronic reminders for patient adherence to medication in chronic disease care. J Telemed Telecare. 2014; 21(1):3-13. DOI: 10.1177/1357633X14541041. View

14.

Gravesande J, Almeida de Oliveira L, Malik N, Vrkljan B, Zheng R, Gardner P . Feasibility, Usability, and Acceptability of Online Mind-Body Exercise Programs for Older Adults: A Scoping Review. J Integr Complement Med. 2023; 29(9):538-549. DOI: 10.1089/jicm.2022.0822. View

15.

Hariprasad V, Koparde V, Sivakumar P, Varambally S, Thirthalli J, Varghese M . Randomized clinical trial of yoga-based intervention in residents from elderly homes: Effects on cognitive function. Indian J Psychiatry. 2013; 55(Suppl 3):S357-63. PMC: 3768212. DOI: 10.4103/0019-5545.116308. View

16.

Choo Y, Chang M . Effects of telecardiac rehabilitation on coronary heart disease: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2022; 101(28):e29459. PMC: 11132407. DOI: 10.1097/MD.0000000000029459. View

17.

Pinto B, Goldstein M, Papandonatos G, Farrell N, Tilkemeier P, Marcus B . Maintenance of exercise after phase II cardiac rehabilitation: a randomized controlled trial. Am J Prev Med. 2011; 41(3):274-83. PMC: 3160619. DOI: 10.1016/j.amepre.2011.04.015. View

18.

Murphy B, Le Grande M, Alvarenga M, Worcester M, Jackson A . Anxiety and Depression After a Cardiac Event: Prevalence and Predictors. Front Psychol. 2020; 10:3010. PMC: 7000459. DOI: 10.3389/fpsyg.2019.03010. View

19.

Elwy A, Groessl E, Eisen S, Riley K, Maiya M, Lee J . A systematic scoping review of yoga intervention components and study quality. Am J Prev Med. 2014; 47(2):220-32. PMC: 4142147. DOI: 10.1016/j.amepre.2014.03.012. View

20.

Ni M, Signorile J, Mooney K, Balachandran A, Potiaumpai M, Luca C . Comparative Effect of Power Training and High-Speed Yoga on Motor Function in Older Patients With Parkinson Disease. Arch Phys Med Rehabil. 2015; 97(3):345-354.e15. DOI: 10.1016/j.apmr.2015.10.095. View