RecruitingNot ApplicableNCT06841562
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study
Sponsor
Duke University
Enrollment
15 participants
Start Date
Jul 14, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria10
- 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
Interventions
BEHAVIORALTRAINERa intensive exercise training
Remotely-delivered exercise training intervention
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06841562
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