Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Study Overview
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Brief Summary
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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.

Official Title
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Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: SWET: Supervised Weight loss and Exercise Training
* Other: CHAT: Counseling Health As Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Counseling Health As Treatment (CHAT)<br>CHAT is a control arm designed to reflect traditional clinical counselling. | Other: CHAT: Counseling Health As Treatment<br>* Control Arm over 16 weeks.<br>|
| Experimental: Supervised Weight loss and Exercise Training (SWET)<br>SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. | Other: SWET: Supervised Weight loss and Exercise Training<br>* Weight loss will occur via a dietitian-led intervention targeting weight loss over 16 weeks, with weekly weigh-ins and group support sessions. Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Syndrome Severity z-score (MSSc) | The primary objective is to compare change in metabolic syndrome score (MSSc) between cohorts. The MS Z-score is a continuous score of the 5 MS variables. A modified Z-score is calculated for each variable using individual subject data, the ATPIII criteria (waist circumference, HDL-cholesterol, triglycerides, blood pressure and fasting glucose) and standard deviations. A z-score of 1 is 1 standard deviation above the mean. A z-score of 2 is 2 standard deviations above the mean. A z-score of -1.8 is -1.8 standard deviations below the mean. A z-score tells you where the score lies on a normal distribution curve. A z-score of zero tells you the value is exactly average while a score of +3 tells you that the value is much higher than average. From this site: https://www.statisticshowto.com/probability-and-statistics/z-score/ | Baseline, 8-weeks, 16-weeks and 24-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass | Change in body mass (weight as measured in kg) within and between groups | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Patient-Reported Outcomes via PROMIS Questionnaire | Change in patient-reported outcomes using PROMIS Global Health Questionnaire within and between groups | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Muscle Mass | Change in muscle mass within and between groups | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Cardiopulmonary Exercise Test | Change in peak VO2 within and between groups | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Activity Monitor - Daily Step Count | Change in daily step count within and between groups | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Muscular Strength - Hand Grip and Leg Strength | Change in upper and lower body strength within and between groups | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Disease Activity Score (DAS-28) | Change in disease activity measured using the DAS-28 within and between groups. Scores range from 0 [very well] to 10 [very poor]. | Baseline, 8-weeks, 16-weeks and 24-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA Seropositive, RA Erosive, Exercise, Diet, Nutrition, Cardiovascular Risk