The Influence of Exercise Training on Musculoskeletal Health in Patients With Systemic Lupus Erythematosus Who Undergo Glucocorticoid Pulse Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Bone health
研究概览
简要总结
This parallel-group randomized, controlled, clinical trial aims to investigate the influence of a 6-month home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.
详细描述
Glucocorticoid treatment is a frequently prescribed to individuals with autoimmune diseases, such as Systemic Lupus Erythematosus, due to its anti-inflammatory effects. This treatment strategy has proven clinical benefits, but it can also adversely influence musculoskeletal health. Glucocorticoid pulse therapy is a particularly intensive treatment strategy, commonly used when the disease state is at its most active. Patients who undergo pulse therapy have a high risk of muscle and bone loss, and exercise training is a promising adjunct therapy to potentially ameliorate these adverse effects, but the feasibility and efficacy of this approach has yet to be investigated. The aim of this study, therefore, is to conduct a parallel-group, controlled, randomized clinical trial, to investigate the feasibility and efficacy of a home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Given that this is an exercise trial, blinding of study participants or investigators is not possible. Whenever possible, outcome assessors (e.g., lab technicians) will be blinded to the participants allocation.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged 18 to 45 diagnosed with Systemic Lupus Erythematosus according to SLICC criteria;
- •Medical indication and prescription for glucocorticoid pulse therapy;
- •Access to Internet and any device that allows for participation in exercise training online lessons (such as smart phone, laptop or personal computer);
- •Willingness to participate in an exercise training program.
排除标准
- •Any physical, mental, neurological or musculoskeletal health impairment that contra-indicates exercise training.
- •Use of medical therapy that alters bone metabolism, such as bisphosphonates, teriparatide and denosumab;
- •Receiving prescription for multiple glucocorticoid pulse therapies mid-intervention;
- •Being currently enrolled or having enrolled in a structured exercise training program in the last 6 months (defined as at least 2 planned, structures sessions of exercise training per week);
- •Having a vertebral fracture at the moment of enrollment (identified by Vertical Fracture Assessment), or high risk for fracture (defined as low hip or spine bone mass [z-score < -3] or history of fragility fractures).
结局指标
主要结局
Bone health
时间窗: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Assessed by dual-energy X-ray absorptiometry, high resolution peripheral quantitative computed tomography and blood bone biomarkers (C-terminal telopeptide \[β-CTX-1\], procollagen type 1 amino-terminal propeptide \[P1NP\], sclerostin, osteocalcin).
次要结局
- Disease-related quality of life(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Aerobic capacity(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Intervention feasibility and acceptability(Entire study duration.)
- Nutritional intake(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- General quality of life(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Physical activity levels(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Current and past bone-loading physical activity levels(Baseline (PRE).)
- Body composition(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Disease activity(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Muscle health(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Cardiovascular risk(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
- Proinflammatory cytokines(Baseline (PRE), after 3 months (MID), and after 6 months (POST).)
研究者
Bruno Gualano
Professor
University of Sao Paulo