N/A
Completed N=24
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Source: ClinicalTrials.gov NCT04356183 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Metabolic Syndrome Severity Z-score (MSSc) — -1.89; -1.82; -3.23; -3.49 Z-score (unitless) — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Syndrome Severity Z-score (MSSc) |
-1.89; -1.82; -3.23; -3.49 | <0.05 sig |
| SECONDARY Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire |
41.7; 42.3; 41.7; 48.1 | <0.05 sig |
| SECONDARY Disease Activity Score (DAS-28) |
3.1; 2.9; 2.9; 2.1 | <0.05 sig |
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 ( 10 pounds in 1 month) within the past 6 months.
- Unwillingness or inability to adhere to the diet structure of the study.
Data sourced from ClinicalTrials.gov (NCT04356183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.