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

*Kontaktforfatter for dette arbejde

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Abstrakt

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.

OriginalsprogEngelsk
Artikelnummere043793
TidsskriftBMJ Open
Vol/bind11
Udgave nummer6
Antal sider6
ISSN2044-6055
DOI
StatusUdgivet - 25. jun. 2021

Bibliografisk note

Funding Information:
Funding This work was supported by The Danish Rheumatism Association—grant number R185-A6606; The AP Moller Foundation—grant number 20-L-0031; Copenhagen University Hospital, Rigshospitalet—grant number N/A.

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