Abstract
BackgroundJuvenile dermatomyositis (JDM) is a rare, often chronic, systemic autoimmune disease of childhood, characterized by inflammation of the microvasculature of the skeletal muscle and skin. Prominent clinical features include significant exercise intolerance, muscle weakness, and fatigue. Despite pharmacological improvements, these clinical features continue to affect patients with JDM, even when the disease is in remission. Exercise training is increasingly utilized as a non-pharmacological intervention in the clinical management of (adult) patients with chronic inflammatory conditions; however no randomized controlled trials (RCT) have been performed in JDM. In the current study, the efficacy and feasibility of an exercise training program in patients with JDM will be examined.Methods/designSubjects (n = 30) will include 8–18 year olds diagnosed with JDM. The intervention consists of an individually tailored 12-weeks home-based exercise training program in which interval training on a treadmill is alternated with strength training during each session. The program is based on previous literature and designed with a defined frequency, intensity, time, and type of exercise (FITT principles). Primary outcome measures include aerobic exercise capacity, isometric muscle strength, and perception of fatigue. The study methodology has been conceived according to the standards of the CONSORT guidelines. The current study will be a multi-center (4 Dutch University Medical Centers) RCT, with the control group also entering the training arm directly after completion of the initial protocol. Randomization is stratified according to age and gender.DiscussionThe current study will provide evidence on the efficacy and feasibility of an individually tailored 12-week home-based exercise training program in youth with JDM.Trial registrationMedical Ethics Committee of the University Medical Center Utrecht, the Netherlands: 11–336; Netherlands Trial Register (NTR): NTR 3184.
Highlights
Juvenile dermatomyositis (JDM) is a rare, often chronic, systemic autoimmune disease of childhood, characterized by inflammation of the microvasculature of the skeletal muscle and skin
The gastrointestinal tract, lungs, heart, and rarely the central nervous system may be involved [10,11,12]. These clinical features are persistently experienced in patients with JDM, even when the disease is in remission [12,13,14]
The outcome measures related to aerobic exercise capacity that will be assessed include: VO2peak [lÁmin-1]: the average volume of the absolute oxygen uptake during the last 30-s period of the test; VO2peak/kg [mlÁkg-1Ámin-1]: the absolute VO2peak divided by body mass
Summary
This paper presents the design of a randomized controlled study that will provide evidence on the efficacy and feasibility of an individually tailored 12-week homebased exercise training program for children and adolescents with JDM. Among the many strength of this study is first, the fact that this will be the first RCT to assess the effects of exercise training in patients with JDM. Perhaps most importantly, the intervention is a home-based program, which minimizes the load for the patients and their parents while likely stimulating the patient’s desire and motivation to continue exercising upon completion of the intervention. Authors’ contributions All authors contributed in designing, drafting, and revising the manuscript, and they all have given approval of the final version. All authors read and approved the final manuscript
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