MedTrace Logo

Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

NCT05090189 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-10-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Bruno Gualano

    lead OTHER

Principal Investigators

  • Eimear Dolan, PhD · Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2023-08-31
Completion
2023-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090189 on ClinicalTrials.gov