SWET/CHAT: Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04356183

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

Enrollment

Location

Arms

19.3

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: SWET: Supervised Weight loss and Exercise Training Other: CHAT: Counseling Health As Treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RandomizedRandomized

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Counseling Health As Treatment (CHAT) CHAT is a control arm designed to reflect traditional clinical counselling.	Other: CHAT: Counseling Health As Treatment Control Arm over 16 weeks.
Experimental: Supervised Weight loss and Exercise Training (SWET) 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 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.

Arm

Intervention/Treatment

Other: Counseling Health As Treatment (CHAT)

CHAT is a control arm designed to reflect traditional clinical counselling.

Other: CHAT: Counseling Health As Treatment

Control Arm over 16 weeks.

Experimental: Supervised Weight loss and Exercise Training (SWET)

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

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.

Outcome Measures

Primary Outcome Measures

Metabolic Syndrome Severity z-score (MSSc) [Baseline, 8-weeks, 16-weeks and 24-weeks]
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/

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.