Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

NCT05090189 | Unknown

• 1 other identifier: The ENRG Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

exercise; autoimmune; training; glucocorticoids

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (PRE), after 3 months (MID), and after 6 months (POST).

Secondary Outcomes (12)

• Muscle health

  Baseline (PRE), after 3 months (MID), and after 6 months (POST).

• Aerobic capacity

  Baseline (PRE), after 3 months (MID), and after 6 months (POST).

• Body composition

  Baseline (PRE), after 3 months (MID), and after 6 months (POST).

• Intervention feasibility and acceptability

  Entire study duration.

• Cardiovascular risk

  Baseline (PRE), after 3 months (MID), and after 6 months (POST).

Study Arms (2)

Exercise training

EXPERIMENTAL

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.

Other: Exercise Training

Control

NO INTERVENTION

The control group will receive standard medical care.

Interventions

Exercise Training OTHER

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.

Exercise training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bruno Gualano: lead

Study Sites (1)

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

São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eimear Dolan, PhD

  Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Gualano, PhD

CONTACT

551126618022; gualano@usp.br

Eimear Dolan, PhD

CONTACT

+447934771844; eimeardolan@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given that this is an exercise trial, blinding of study participants or investigators is not possible. Whenever possible, outcome assessors (e.g., lab technicians) will be blinded to the participants allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 22, 2021
• Study Start: August 27, 2021
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Anonymised data will be made permanently available upon study completion and once data has been analysed and submitted for publication.
• Access Criteria: Anonymised data will be accessible to anyone interested via online repositories.

Locations

BR (1)