Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

Systemic Lupus Erythematosus Clinical Trial

Official title:

The Influence of Exercise Training on Musculoskeletal Health in Patients With Systemic Lupus Erythematosus Who Undergo Glucocorticoid Pulse Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090189
• Other study ID #: The ENRG Study
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: November 2023

Study information

• Verified date: October 2021
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 551126618022
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• Exercise Training
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.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of the School of Medicine, University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Bruno Gualano

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone health	Assessed by dual-energy X-ray absorptiometry, high resolution peripheral quantitative computed tomography and blood bone biomarkers (C-terminal telopeptide [ß-CTX-1], procollagen type 1 amino-terminal propeptide [P1NP], sclerostin, osteocalcin).	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Muscle health	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).	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Aerobic capacity	Assessed by maximal graded ergospirometric test.	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Body composition	Assessed by dual-energy X-ray absorptiometry (fat mass, percentage body fat, lean mass), body mass index, waist and hip circumferences.	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Intervention feasibility and acceptability	Assessed by feasibility metrics: Recruitment Capacity, Acceptability and Suitability, Resources, and Intervention Efficacy.	Entire study duration.
Secondary	Cardiovascular risk	Assessed by Framingham Risk Score	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Proinflammatory cytokines	Assessed by interferon gamma (IFN-?), interleukin 10 and 6 (IL-10, IL-6), tumor necrosis factor alpha (TNF-a), and soluble TNF receptors (sTNFR1 e sTNFR2) assays.	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Nutritional intake	Assessed by three non-consecutive food recalls.	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Disease activity	Assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	General quality of life	36-Item Short Form Survey (SF-36).	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Disease-related quality of life	Assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQOL)	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Physical activity levels	Assessed by International Physical Activity Questionnaire (IPAQ)	Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary	Current and past bone-loading physical activity levels	Assessed by Bone-Specific Physical Activity Questionnaire (BPAQ).	Baseline (PRE).