Yoga for pain and sleep quality in rheumatoid arthritis: study protocol for a pilot randomized controlled trial

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 RArelated 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 relaxationbased 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.

Inequity in exercise-based interventions for adults with rheumatoid arthritis: a systematic review

“…A total of 4382 participants were included (sample size ranged from 20 [ 66 ] to 490 [ 46 ] participants). Participant ages ranged from 18 [ 27 , 32 , 33 , 36 , 38 , 45 , 55 , 67 , 70 ] to 87 years [ 22 ]. The majority of participants were female ( n = 3431) [ 21–70 ].…”

“…Interventions included strengthening exercise ( n = 26) [ 21 , 23–25 , 27 , 30 , 31 , 35 , 36 , 38 , 42 , 43 , 45–48 , 50 , 51 , 54 , 55 , 58 , 59 , 61 , 63 , 64 , 68 ], aerobic exercise ( n = 17) [ 21 , 23–25 , 27 , 29 , 36 , 38 , 44 , 45 , 47 , 55 , 59 , 61 , 63 , 64 , 68 ], flexibility exercises ( n = 10) [ 25 , 30 , 31 , 35 , 36 , 46 , 51 , 54 , 63 , 64 ], yoga ( n = 8) [ 37 , 39–41 , 52 , 56 , 62 , 67 ], walking ( n = 5) [ 30 , 36 , 57 , 69 , 70 ], hydrotherapy ( n = 4) [ 26 , 27 , …”

Yoga for the management of pain and sleep in rheumatoid arthritis: a pilot randomized controlled trial

“…A detailed study protocol has been previously reported (Ward, Stebbings, Athens et al, ), and is summarized below. The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612001019897), received ethical approval from the Southern Health and Disability Ethics Committees (Ref 12/STH/24) and Health Research South (ID00837), and was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments.…”

“…Participants allocated to the yoga group continued with their usual medical care provided by their rheumatologist and general practitioner. Additionally, they commenced an 8‐week programme of group and home yoga practice (Ward, Stebbings, Athens, et al, ).…”

CLARIFY 2021: explanation and elaboration of the Delphi-based guidelines for the reporting of yoga research

“…'Adherence to home practice in the previous week was verbally reported to the yoga instructor at the beginning of each session, and barriers and adherers to home practice were discussed among the group.' 22…”