Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

Bruno Gualano

Status: Unknown

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05090189

The ENRG Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Exercise training

Experimental group

Description:

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.

Treatment:

Other: Exercise Training

Control

No Intervention group

Description:

The control group will receive standard medical care.