MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics

Completed · Not applicable

Conditions studied: Rheumatoid Arthritis, Healthy Controls

In brief

Persons with rheumatoid arthritis (RA) suffer from increased disability and mortality, in part resulting from skeletal muscle impairments. In this study, our objective is to determine if skeletal muscle biomechanical properties are altered in RA. Up to 15 participants with early RA defined as duration of disease/symptoms of less than 6 months (where "duration" denotes the length of time the patient has had symptoms/disease, not the length of time since RA diagnosis) AND prior to starting biologic Disease-modifying anti-rheumatic drugs (bDMARD) therapy and 15 age-, sex-, and BMI-matched controls will undergo clinical assessments of skeletal muscle stiffness and elasticity as measured by the hand-held MyotonPro device. Additional study participant assessments include cardiopulmonary exercise testing, muscle strength testing, body composition measurement using BodPod, muscle oxidative capacity testing using near-infrared spectroscopy, and thigh muscle needle biopsies to compare clinical findings to an ex vivo cultured myobundle system. Primary statistical analyses will be comparisons of skeletal muscle parameters in RA compared to controls and correlations to determine relationships between variables. Thigh muscle biopsies are a low-risk procedure that may cause minor local soreness and bleeding; all other clinical assessments are non-invasive and will induce minimal discomfort to participants.

Key facts

Study ID

NCT04226131

Run by

Duke University

People needed

21

Starts

2020-09-09

Expected to finish

2023-07-07

Last updated by the study team

2023-07-13

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Early RA participants will be excluded if they have already started bDMARD therapy.
• The investigators will exclude persons using non-aspirin anticoagulants that would complicate the biopsy. There will be a wash-out period of seven days for anti-platelet agents, and three days for NSAIDs prior to biopsies.
• Uncontrolled thyroid diseases
• Chronic obstructive lung disease
• Parkinson's disease
• Ankylosing spondylitis
• Congestive Heart Failure Class III and above will be excluded based on recognized effects on skeletal muscle.
• Patients with absolute or relative contraindications to exercise will be excluded: recent (<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection, left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree atrioventricular (AV) block, ventricular aneurysm.
• Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxoedema)
• Uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis)
• Mental or physical impairment leading to inability to exercise adequately
• Pregnant women will be excluded as determined via menstrual history/self-reporting.

Where it is running

• Duke Center for Living — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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