Remote intensive aerobic and strength training for early rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot delivers an intensive combined aerobic and resistance exercise program remotely to people with early, active rheumatoid arthritis. Participants follow a structured home-based regimen with remote supervision and monitoring while investigators record adherence, safety, and preliminary clinical and feasibility outcomes. The protocol builds on a recent project to collect additional data needed for sample-size and power calculations for a larger trial. Results will inform whether remotely supervised intensive exercise is practical to implement in early RA care and help design a definitive study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and not currently taking biologic DMARD therapy. Participants may be on one or a combination of the following conventional synthetic DMARDs: hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, azathioprine
* Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs
* History of fulfilling 2010 ACR/EULAR Classification Criteria for RA
* Active RA, not in clinical disease remission (Clinical Disease Activity Index for RA (CDAI) \> 2.8)
* Stable doses (for ≥ 1 month) of all RA and cardiovascular risk-related medications (including statins, metformin, SGLT2 inhibitors, GLP1RA) except for glucocorticoids

Exclusion Criteria:

* Pregnant or intending to become pregnant during the intervention period
* Current treatment with exogenous insulin
* Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease
* Current malignancy other than minimally invasive carcinomas routinely treated topically or with minor surgical treatment
* Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
* Relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension (see below), significant anemia, important electrolyte imbalance, and hyperthyroidism
* Acute myocardial infarction (MI) within six months
* Resting hypertension with systolic or diastolic blood pressures ≥180/110 mm Hg
* Lack of internet access
* Planned, intentional weight loss during study

Where it's running

• Duke University
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Brian J Andonian, MD, MHSc — Duke University
• Study coordinator: Johanna Johnson, MS
• Email: johanna.johnson@duke.edu
• Phone: 19196606766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.