N/A N=24 Randomized Single-blind Treatment

Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT04356183 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Metabolic Syndrome Severity Z-score (MSSc) — -1.89; -1.82; -3.23; -3.49 Z-score (unitless) — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SWET: Supervised Weight loss and Exercise Training (Other); CHAT: Counseling Health As Treatment (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Feb 2023

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

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 ( 10 pounds in 1 month) within the past 6 months.
Unwillingness or inability to adhere to the diet structure of the study.

View full record on ClinicalTrials.gov →

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.