NCT04356183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 21, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 8, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

April 13, 2020

Results QC Date

February 2, 2024

Last Update Submit

March 27, 2025

Conditions

Rheumatoid Arthritis

Keywords

RA SeropositiveRA ErosiveExerciseDietNutritionCardiovascular Risk

Outcome Measures

Primary Outcomes (1)

  • Metabolic Syndrome Severity Z-score (MSSc)

    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.

    Baseline and 16 weeks

Secondary Outcomes (2)

  • Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire

    Baseline and 16 weeks

  • Disease Activity Score (DAS-28)

    Baseline and 16 weeks

Study Arms (2)

Counseling Health As Treatment (CHAT)

OTHER

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

Other: CHAT: Counseling Health As Treatment

Supervised Weight loss and Exercise Training (SWET)

EXPERIMENTAL

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

Interventions

SWET: Supervised Weight loss and Exercise TrainingOTHER

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.

Supervised Weight loss and Exercise Training (SWET)
CHAT: Counseling Health As TreatmentOTHER

Control Arm over 16 weeks.

Counseling Health As Treatment (CHAT)

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Center for Living

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • 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.

    PMID: 40490834DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Interventions

ExerciseTherapeutics

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Kim Huffman, MD, PhD
Organization
Duke University
kim.huffman@duke.edu
919-613-7797

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 22, 2020

Study Start

July 21, 2021

Primary Completion

February 3, 2023

Study Completion

February 23, 2023

Last Updated

March 30, 2025

Results First Posted

March 8, 2024

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)