Effects of a land and aquatic exercise-based program on pain, mobility and quality of life in patients with chronic low back pain: a study protocol for a randomized controlled trial

一项基于陆地和水上运动的康复计划对慢性腰痛患者的疼痛、活动能力和生活质量的影响:一项随机对照试验的研究方案

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Abstract

BACKGROUND: Chronic low back pain (CLBP) is a disease with significant functional, emotional and social impact. Several interventions are proposed for its management and exercise is one of main, land-based or water-based. This study describes a randomized controlled trial that will analyze the effect of a combined aquatic and land-based exercise program compared to an aquatic-based program on pain, functional incapacity and quality of life in adults with CLBP. Additionally, it will analyze the effects of exercise cessation in the same outcomes. METHODS AND DESIGN: A blind randomized controlled trial will be developed with a 1:1 allocation ratio. Around 30 adults with mechanical CLBP will be randomly allocated in two groups. The experimental group (ALG) will complete an aquatic and land-based exercise program and control group (AG) will carry out only an aquatic program, both for 8 weeks. Participants will be assessed with Visual Analogue Scale, Oswestry Disability Index, Short-Form 36, Tampa Scale of Kinesiophobia-13 and Modified-Modified Schober Test, collected at baseline (M0), after 8 weeks (M1) and 4 weeks after the end of the intervention (M2). DISCUSSION: This study may provide a relevant contribution to understand the potential effect of a combined land and aquatic exercise program on pain, functional disability, fear of movement, quality of life and lumbar mobility. The results may provide important information for CLBP management. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov (registration number: NCT06641570; date of registration: October 14, 2024).

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