Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 17, 2020
Date Accepted: Aug 11, 2020
The effect of 12-week internet-based individualized exercise program in adults with systemic lupus erythematosus: A randomized controlled trial
ABSTRACT
Background:
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease, which is associated with a high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting and fatigue. During the last years, exercise therapy has become an important part of long-time treatment of comorbidities in SLE. Previous studies indicate that exercise can lead to various benefits in patients with SLE; related to an increased aerobic capacity, exercise tolerance, quality of life and decreased depression and fatigue. At the moment no evidence-based guidelines exist and the efficacy of different training programs require further investigation.
Objective:
This study focuses on the practicability, efficacy, and safety of an internet-based exercise program in patients with SLE. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training.
Methods:
Thirty SLE patients with clinically stable status are included and randomized in an aerobic exercise group (n = 10), anaerobic exercise group (n = 10), or treatment as usual (TAU) group (n = 10). After completing initial clinical testing and physical fitness tests, the patients undergo a 12-week, online supervised exercise program, receiving weekly individualized training plans adapted to their physical performance. Primary endpoint is the change of physical fitness (VO2peak) after 12-weeks compared to baseline. Secondary endpoints are the disease activity via laboratory results (complement, autoantibodies) and questionnaires (FSMC, DAS 28, BDI, WAI, SLEDAI) as well as changes of the muscle mass (BIA), results of the Chair-Stand-Test (CST) and the measurements of circulating cell-free DNA (cfDNA) and extra cellular vesicles (EVs).
Results:
40 patients were screened initially. 31 patients fulfilled the inclusion criteria and were included in the study. So far a number of 25 patients completed the study, showing no serious adverse events. Currently, the study has not yet been completed, so that no evaluated data are presented below, but the study design is described in detail.
Conclusions:
Online exercise intervention seems to be a feasible, and efficient tool to provide regular individualized exercise recommendations in the management of SLE patients. Clinical Trial: NCT03942718, date of registration: May 8, 2019
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