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Abstract
Background:
Yoga is a popular complementary and alternative medicine (CAM) therapy among people with rheumatoid arthritis (RA), perceived as offering self-management options for physical and psychosocial symptoms associated with RA.
Objectives:
The primary aims of the current pilot study are (1) to assess the feasibility and safety of a relaxation-focused yoga intervention tailored for people with RA and (2) to estimate the effect of yoga on RA-related pain, sleep quality, functional disability, disease activity, quality of life, anxiety, depression, and fatigue.
Method:
Twenty-eight participants with at least minimum levels of RA-related pain and sleep disturbance will be recruited from a local public hospital database. Participants meeting inclusion criteria will be randomized into either a yoga group (receiving an 8-week program of once-weekly 75-minute relaxation-based yoga classes and thrice-weekly home practice), or a usual care control group. Outcomes will be assessed at baseline, 9, and 12 weeks. Feasibility is operationalized as acceptability (recruitment, adherence, participant retention, and participant satisfaction) and safety of the yoga intervention. Effect sizes for changes in pain, sleep quality, functional disability, disease activity, quality of life, mental health, and fatigue will be estimated.
Discussion:
Results of this pilot study will provide empirical data to determine if a larger, statistically powered main trial is feasible and safe in a national RA population. Additionally, participant feedback will provide information regarding further adaption and tailoring of the study protocol to a clinical RA population.
Trial registration:
Australian New Zealand Clinical Trials Registry ACTRN12612001019897 (registered 20/09/2012).
Acknowledgements
The authors gratefully acknowledge Robin Rothenberg for her role in the development of the yoga program, and her mentorship of LW; Karen Sherman for her advice in study design; and Robert Saper, Diana Taibi, and Michael V. Vitiello for the generous use of their study protocols and teacher manuals from previous interventions of yoga for musculoskeletal conditions. We thank the following people for their assistance in the conduct of the study: Recruitment: Debra McNamara and staff of the Rheumatology outpatient clinics, Dunedin Public Hospital; Assessments: Debra McNamara, Lynne Clay, and Poonam Mehta; Class assistants: Rachel Dalley, Gina Isbister, and Christine Livesey; Administrative assistance: Marina Moss.