High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol

Kasper Yde Jensen, Per Aagaard, Henrik Daa Schrøder, Charlotte Suetta, Jakob Lindberg Nielsen, Eleanor Boyle, Louise Pyndt Diederichsen, Kasper Yde Jensen, Per Aagaard, Henrik Daa Schrøder, Charlotte Suetta, Jakob Lindberg Nielsen, Eleanor Boyle, Louise Pyndt Diederichsen

Abstract

Introduction: Idiopathic inflammatory myopathies (IIMs) are rare diseases characterised by non-suppurative inflammation of skeletal muscles and muscle weakness. Additionally, IIM is associated with a reduced quality of life. Strength training is known to promote muscle hypertrophy and increase muscle strength and physical performance in healthy young and old adults. In contrast, only a few studies have examined the effects of high intensity strength training in patients with IIM and none using a randomised controlled trial (RCT) set-up. Thus, the purpose of this study is to investigate the effects of high-intensity strength training in patients affected by the IIM subsets polymyositis (PM), dermatomyositis (DM) and immune-mediated necrotising myopathy (IMNM) using an RCT study design.

Methods and analysis: 60 patients with PM, DM or IMNM will be included and randomised into (1) high-intensity strength training or (2) Care-as-Usual. The intervention period is 16 weeks comprising two whole-body strength exercise sessions per week. The primary outcome parameter will be the changes from pre training to post training in the Physical Component Summary measure in the Short Form-36 health questionnaire. Secondary outcome measures will include maximal lower limb muscle strength, skeletal muscle mass, functional capacity, disease status (International Myositis Assessment and Clinical Studies Group core set measures) and questionnaires assessing physical activity levels and cardiovascular comorbidities. Furthermore, blood samples and muscle biopsies will be collected for subsequent analyses.

Ethics and dissemination: The study complies with the Helsinki Declaration II and is approved by The Danish Data Protection Agency (P-2020-553). The study is approved by The Danish National Committee on Health Research Ethics (H-20030409). The findings of this trial will be submitted to relevant peer-reviewed journals. Abstracts will be submitted to international conferences.

Trial registration number: NCT04486261.

Keywords: rehabilitation medicine; rheumatology; sports medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study schematics. The intervention group will receive 16 weeks of high-intensity strength training. The control group will receive Care-as-Usual throughout the intervention period, defined as keeping physical activity levels the same as prior to participation in the study. Both groups will maintain the usual medical treatment related to the myositis disease throughout the intervention period.

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