Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT04356183
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-22
• Study Start: 2021-07-21
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-23
• Results First Submitted: 2024-02-02
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome Severity Z-score (MSSc)	Baseline and 16 weeks	The primary objective is to compare change in metabolic syndrome z-score (MSSc) between groups. The MSSc is a continuous weighted score of the five metabolic syndrome variables-fasting high-density lipoprotein cholesterol, triglycerides, glucose, waist circumference, and mean arterial blood pressure. A modified z-score was calculated for each participant using continuous differences between the Adult Treatment Panel (ATP) III guideline values and participant values with normalization to the cohort's standard deviations. To account for variations in ATP III criteria between men and women, the investigators used sex-specific MSSc equations. A lower MSSc indicates a better outcome.

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score (DAS-28)	Baseline and 16 weeks	Change in disease activity measured using the DAS-28. DAS-28 is a composite measure including a self-reported overall health assessment on a 100 mm visual analog scale, the number of tender and swollen joints determined from a 28-joint examination, and C-reactive protein. Scores range from 0 \[very well\] to 10 \[very poor\].
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire	Baseline and 16 weeks	Change in patient-reported outcomes using PROMIS Physical Function Questionnaire. The questionnaire was scored using "response pattern scoring" according to the PROMIS scoring manual in order to calculate the T-score for this outcome measure. The population mean T-score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average.

Trial Locations

Locations (1)

Duke Center for Living; 🇺🇸 Durham, North Carolina, United States