Outcomes of 16 weeks of combined exercises on Cobb angle, bone and muscle health, and quality of life in females with idiopathic scoliosis: a study protocol for a single-blinded randomised controlled trial

一项单盲随机对照试验的研究方案:为期16周的综合运动疗法对特发性脊柱侧弯女性患者的Cobb角、骨骼和肌肉健康以及生活质量的影响

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Abstract

INTRODUCTION: Scoliosis-specific exercises require specialist supervision, frequent clinical visits, and high costs, limiting accessibility. Additionally, females with idiopathic scoliosis (IS) engage in less physical activity (PA) than sex- and age-matched peers, leading to poorer bone and muscle health. These challenges underscore the need for accessible, home-based interventions targeting both musculoskeletal health and spinal alignment. METHODS AND ANALYSIS: This single-blinded, randomised controlled trial aims to investigate the efficacy of a 16-week home-based exercise intervention on bone mineral density (BMD), Cobb angle, spinal flexibility, core muscle endurance, lean body mass, and quality of life (QoL) in females with IS. 28 participants will be randomly assigned (1:1) to either an intervention group (IG) or a control group (CG). Both groups will perform Schroth and core stabilisation exercises three times per week, while the IG will additionally perform impact-loading exercises. The primary outcome is BMD. Secondary outcomes include Cobb angle, lean body mass, cosmetic trunk deformity, spinal flexibility, core muscle endurance, and QoL. All outcomes will be assessed at baseline and post-intervention, with interim evaluations (excluding BMD, Cobb angle, and lean body mass) conducted at weeks 4, 8, and 12. All assessors, radiologists, and statisticians will remain blinded to group allocation. Treatment effects between groups over time will be analysed using two-way mixed-design analysis of variance (ANOVA). DISCUSSION: This study addresses a critical gap in IS management by integrating a preventive and therapeutic home-based programme. The approach aims to improve musculoskeletal health, spinal alignment, and overall QoL. Its accessible format may inform future guidelines for conservative treatment and early intervention. Such interventions could significantly enhance bone health, reduce the risk of progression, and improve long-term musculoskeletal outcomes in young females with mild to moderate IS. ETHICS AND DISSEMINATION: This study has received ethical approval from the Research Ethics Committee, Faculty of Associated Medical Sciences, Chiang Mai University (No. AMSEC-67EX-045). The findings will be disseminated through a peer-reviewed publication. TRIAL REGISTRATION NUMBER: TCTR20241001001.

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