Status:
COMPLETED
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomize...
Eligibility Criteria
Inclusion
- Body mass index (BMI) 28-40 kg/m2.
- Must have internet access.
- Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.
Exclusion
- Subject unwilling/unable to utilize online platforms (e.g. ZOOM, REDCap, Pattern Health) for study activities.
- Current use of biologic agents other than those targeting tumor necrosis factor alpha.
- Current (within the last month) pharmacologic therapy with corticosteroids at doses greater than prednisone 5mg per day (or equivalent glucocorticoid doses).
- Participating in regular exercise within the past 3 months (According to 2018 US guidelines: Not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise).
- New medications within the last three months and stable doses for ≥ 1 month.
- Diagnosis of coronary artery disease.
- Diagnosis of type 2 diabetes mellitus.
- Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease.
- Absolute contra-indications to exercise: 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.
- Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately.
- Significant weight change (gain or loss of \> 10 pounds in 1 month) within the past 6 months.
- Unwillingness or inability to adhere to the diet structure of the study.
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04356183
Start Date
July 21 2021
End Date
February 23 2023
Last Update
March 30 2025
Active Locations (1)
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1
Duke Center for Living
Durham, North Carolina, United States, 27705