|
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis
RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2025-07-14
Est. completion2027-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06841562
Summary
The primary objective of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise program for patients with Rheumatoid Arthritis (RA) and to collect data to support power calculations for a larger research study.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and prior to starting 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 \>160/90 mm Hg * Lack of internet access * Planned, intentional weight loss during study
Conditions2
ArthritisRheumatoid Arthritis
Locations1 site
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2025-07-14
Est. completion2027-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06841562