Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

Bruno Gualano50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

Exercise TrainingOTHER

The present intervention will consist of a 6-month long, twice-weekly, home-based, monitored exercise training program, with training sessions lasting around 40 minutes, with 48 sessions in total. The program will be delivered in the form of 6 x 4-week "blocks", which will progressively increase in intensity and complexity, as the participants physical capacities develop. Additionally, and in addition with current physical activity guidelines, participants will be instructed to perform at least an additional 70 minutes of purposeful activities per week. Study trainers will discuss the content of these activities with each individual participant to facilitate selection of suitable activities (e.g., brisk walking, jogging, stair climbing or bike riding), but their selection will be left to the discretion of the individual participants, and activity logs will be maintained throughout the study period.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Locations (1)

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Bone health

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).