Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

NCT ID: NCT04356183

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2023-02-23

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Counseling Health As Treatment (CHAT)

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

Group Type: OTHER

CHAT: Counseling Health As Treatment

Intervention Type: OTHER

Control Arm over 16 weeks.

Supervised Weight loss and Exercise Training (SWET)

SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session.

Group Type: EXPERIMENTAL

SWET: Supervised Weight loss and Exercise Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

CHAT: Counseling Health As Treatment

Control Arm over 16 weeks.

Intervention Type: OTHER

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 (<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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke Center for Living

Durham, North Carolina, United States

Countries

United States

References

Kim G, Ross LM, Sudnick AM, Johnson JL, Pieper CF, Connelly MA, Ilkayeva O, Muehlbauer MJ, Bales CW, Porter Starr KN, Kraus WE, Andonian BJ, Huffman KM. The impact of lifestyle modification on metabolic pathways in older adults with overweight/obesity and rheumatoid arthritis: a secondary exploratory analysis of the SWET-RA study. BMC Rheumatol. 2025 Jun 9;9(1):68. doi: 10.1186/s41927-025-00525-8.

Reference Type: DERIVED

PMID: 40490834 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AR076663

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00104843

Identifier Type: -

Identifier Source: org_study_id