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

• Published in: BMJ open Vol. 11; no. 6; p. e043793
• Main Authors: Jensen, Kasper Yde, Aagaard, Per, Schrøder, Henrik Daa, Suetta, Charlotte, Nielsen, Jakob Lindberg, Boyle, Eleanor, Diederichsen, Louise Pyndt
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 25-06-2021; BMJ Publishing Group
• Series: Protocol
• Subjects: Disease; Exercise; Inflammation; Inflammatory diseases; Intervention; Muscle strength; Musculoskeletal diseases; Patients; Performance evaluation; Physical fitness; Quality of life; Rare diseases; Rheumatology; Sports training; Strength training; Substance abuse treatment
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-043793

IntroductionIdiopathic 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 analysis60 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 disseminationThe 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 numberNCT04486261.