Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Other: Exercise Training
- Registration Number
- NCT05090189
- Lead Sponsor
- Bruno Gualano
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise training Exercise Training The experimental arm will enroll in a 6-month, twice-weekly, home-based, remotely monitored exercise training program, the emphasis of which will be to improve musculoskeletal health and function.
- Primary Outcome Measures
Name Time Method Bone health 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).
- Secondary Outcome Measures
Name Time Method Disease-related quality of life Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQOL)
Aerobic capacity Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by maximal graded ergospirometric test.
Intervention feasibility and acceptability Entire study duration. Assessed by feasibility metrics: Recruitment Capacity, Acceptability and Suitability, Resources, and Intervention Efficacy.
Nutritional intake Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by three non-consecutive food recalls.
General quality of life Baseline (PRE), after 3 months (MID), and after 6 months (POST). 36-Item Short Form Survey (SF-36).
Physical activity levels Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by International Physical Activity Questionnaire (IPAQ)
Current and past bone-loading physical activity levels Baseline (PRE). Assessed by Bone-Specific Physical Activity Questionnaire (BPAQ).
Body composition Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by dual-energy X-ray absorptiometry (fat mass, percentage body fat, lean mass), body mass index, waist and hip circumferences.
Disease activity Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
Muscle health Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by dual-energy X-ray absorptiometry (fat-free mass), one-repetition maximum test (bench press and leg extension), and muscle functionality tests (timed-up-and-go, timed-stands, handgrip).
Cardiovascular risk Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by Framingham Risk Score
Proinflammatory cytokines Baseline (PRE), after 3 months (MID), and after 6 months (POST). Assessed by interferon gamma (IFN-γ), interleukin 10 and 6 (IL-10, IL-6), tumor necrosis factor alpha (TNF-α), and soluble TNF receptors (sTNFR1 e sTNFR2) assays.
Trial Locations
- Locations (1)
Clinical Hospital of the School of Medicine, University of Sao Paulo
🇧🇷Sao Paulo, Brazil