Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk (SWET/CHAT)

Duke University

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: CHAT: Counseling Health As Treatment; Other: SWET: Supervised Weight loss and Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04356183

R21AR076663 (U.S. NIH Grant/Contract)

Pro00104843

Details and patient eligibility

About

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 randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training (SWET) program.

Enrollment: 24 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Counseling Health As Treatment (CHAT)

Other group

Description:

CHAT is a control arm designed to reflect traditional clinical counselling.

Treatment:

Other: CHAT: Counseling Health As Treatment

Supervised Weight loss and Exercise Training (SWET)

Experimental group

Description:

SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session.

Treatment:

Other: SWET: Supervised Weight loss and Exercise Training