Clinical trial NCT05090189: Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
Official title: The Influence of Exercise Training on Musculoskeletal Health in Patients With Systemic Lupus Erythematosus Who Undergo Glucocorticoid Pulse Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: exercise
autoimmune
training
glucocorticoids
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study comprises a 6-month parallel-group, randomized, controlled trial, in which individuals with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy (500-1000mg/d methylprednisolone i.v., 1-3 days), will be randomized into one of two conditions: control, consisting of no intervention and standard medical care; and exercise training, consisting of standard medical care supplemented by a twice-weekly, home-based, remotely monitored exercise training program. Patients will be assessed at three timepoints, namely 1-3 weeks after pulse therapy (according to patient's health state and willingness, PRE); three months after baseline (MID); and six months after baseline (POST).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Bone health
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary outcomes:
measure: Muscle health
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Aerobic capacity
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Body composition
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Intervention feasibility and acceptability
timeFrame: Entire study duration.
measure: Cardiovascular risk
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Proinflammatory cytokines
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Nutritional intake
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Disease activity
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: General quality of life
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Disease-related quality of life
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Physical activity levels
timeFrame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
measure: Current and past bone-loading physical activity levels
timeFrame: Baseline (PRE).
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Clinical Hospital of the School of Medicine, University of Sao Paulo
Study officials:
affiliation: Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
name: Eimear Dolan, PhD
role: PRINCIPAL_INVESTIGATOR
References: