Effects of a home-based exercise combined yoga and resistance training in enthesitis-related arthritis in China: study protocol for a randomised controlled trial.

INTRODUCTION: Enthesitis-related arthritis (ERA) is a category of juvenile idiopathic arthritis (JIA). The complications of JIA include pain, muscle weakness, limited movement and worsening quality of life. Yoga is an effective exercise therapy for rheumatoid arthritis and may have similar benefits for JIA. Considering the limitation of yoga for strengthening muscles, combined yoga and resistance training (CYRT) may compensate for the shortcomings and provide more benefits for JIA patients. Despite this, there is currently a lack of studies investigating the effectiveness of CYRT for JIA patients. Due to the inaccessibility of traditional exercise therapy, home-based exercise is needed. The study aims to assess the effectiveness of home-based CYRT on JIA.

METHODS AND ANALYSIS: This is a 12-week randomised single-blind controlled trial study. 60 patients with ERA will be randomised into two groups: the home-based exercise group (HBE) and the health education (HE) group. The HBE group (n=30) will perform the CYRT programme 3 times a week at home for 12 weeks and receive HE. The HE group (n=30) will only receive HE. The outcomes include primary outcome (pain levels) and secondary outcomes (lower limb muscle strength, motion range of joint, aerobic fitness, function ability, fatigue levels, mental health, quality of life and blood biomarkers). The assessments will be conducted at baseline, postintervention (12 weeks) and follow-up (24 weeks). Data will be analysed by intention to treat.

ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine in December 2023 (approval no. XHEC-C-2023-059-3). This study will require informed consent from all subjects and guardians of children under 18 years of age. The findings will be published in a peer-reviewed journal and international conferences.

TRIAL REGISTRATION NUMBER: ChiCTR2300073446.