Clinical trial NCT04356183: Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Official title: Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: RA Seropositive
RA Erosive
Exercise
Diet
Nutrition
Cardiovascular Risk
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-04-22
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic Syndrome Severity Z-score (MSSc)
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire
timeFrame: Baseline and 16 weeks
measure: Disease Activity Score (DAS-28)
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Living
state: North Carolina
Study officials:
References: