Remote intensive aerobic and strength training for early rheumatoid arthritis
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study
Try a supervised at-home program that combines aerobic and strength training for people with early, active rheumatoid arthritis to see if it is practical and doable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06841562 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with early RA (diagnosis ≤6 months), seropositive or with typical erosions, active disease (CDAI >2.8), not currently on biologic DMARDs, and on stable conventional DMARDs and cardiovascular medications are the ideal candidates.
Not a fit: People with long-standing or inactive RA, those taking biologic DMARDs or exogenous insulin, pregnant individuals, or those with other inflammatory arthropathies are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, this program could make supervised, intensive exercise more accessible at home and potentially improve physical function and disease control for people with early RA.
How similar studies have performed: Prior exercise interventions have shown benefits in RA generally, but intensive, remotely supervised combined aerobic and resistance programs in early RA are relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.