Effect of an exercise intervention on aerobic capacity in people with myositis: a waitlist randomised control trial

The University of Sydney0 sites32 target enrollmentJune 28, 2024

Overview

No summary available.

Registry

who.int

Start Date

June 28, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Greater than or equal to 18 years of age
•Diagnosis of dermatomyositis, polymyositis or immune\-mediated necrotizing myopathy (IMNM), made by a medical practitioner, and in accordance with European league against rheumatism (EULAR)/American college of rheumatology (ACR) Classification Criteria for Adult and Juvenile Idiopathic inflammatory myopathy (IIM) and their Major Subgroups (High probability more than 55% on calculator for IIM).
•Disease duration greater than 3months
•History of significant muscle inflammation (myositis) that has impacted health and been a major consideration in treatment decisions as judged by the treating physician
•Willingness to provide informed consent and willingness to participate and comply with the study requirements
•Deemed safe to exercise according to the Exercise and Sport Science Australia (ESSA) pre\-screening form and baseline clinical assessments

•Less than 18 years of age
•Inclusion Body Myositis (IBM)
•Amyopathic Dermatomyositis (ADM)
•Contraindication or inability to exercise as determined by the ESSA pre\-screening form and baseline clinical assessments
•Currently pregnant or planning pregnancy
•Diagnosis of condition(s) that may limit ability and safety to perform exercise (e.g., unstable cardiovascular disease, uncontrolled congestive heart failure, known heart failure)
•Active malignancy
•Severe interstitial lung disease (ILD) with a diffusing capacity of the lungs for carbon monoxide (DLCO) \<40% and/or a forced vital capacity (FVC) less than 60%
•Renal impairment (estimated glomerular filtration rate (GFR) less than 30mL/min/1\.73m2\)