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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SWET: Supervised Weight loss and Exercise Training
CHAT: Counseling Health As Treatment
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA Seropositive, RA Erosive, Exercise, Diet, Nutrition, Cardiovascular Risk

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Duke Center for Living

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Counseling Health As Treatment (CHAT)

Supervised Weight loss and Exercise Training (SWET)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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/

Secondary Outcome Measures

Body Mass
Change in body mass (weight as measured in kg) within and between groups
Patient-Reported Outcomes via PROMIS Questionnaire
Change in patient-reported outcomes using PROMIS Global Health Questionnaire within and between groups
Muscle Mass
Change in muscle mass within and between groups
Cardiopulmonary Exercise Test
Change in peak VO2 within and between groups
Activity Monitor - Daily Step Count
Change in daily step count within and between groups
Muscular Strength - Hand Grip and Leg Strength
Change in upper and lower body strength within and between groups
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].

Full Information

First Posted
April 13, 2020
Last Updated
March 30, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04356183
Brief Title
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Acronym
SWET/CHAT
Official Title
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
February 3, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA Seropositive, RA Erosive, Exercise, Diet, Nutrition, Cardiovascular Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling Health As Treatment (CHAT)
Arm Type
Other
Arm Description
CHAT is a control arm designed to reflect traditional clinical counselling.
Arm Title
Supervised Weight loss and Exercise Training (SWET)
Arm Type
Experimental
Arm Description
SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session.
Intervention Type
Other
Intervention Name(s)
SWET: Supervised Weight loss and Exercise Training
Intervention Description
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
Intervention Name(s)
CHAT: Counseling Health As Treatment
Intervention Description
Control Arm over 16 weeks.
Primary Outcome Measure Information:
Title
Metabolic Syndrome Severity z-score (MSSc)
Description
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/
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Secondary Outcome Measure Information:
Title
Body Mass
Description
Change in body mass (weight as measured in kg) within and between groups
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Title
Patient-Reported Outcomes via PROMIS Questionnaire
Description
Change in patient-reported outcomes using PROMIS Global Health Questionnaire within and between groups
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Title
Muscle Mass
Description
Change in muscle mass within and between groups
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Title
Cardiopulmonary Exercise Test
Description
Change in peak VO2 within and between groups
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Title
Activity Monitor - Daily Step Count
Description
Change in daily step count within and between groups
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Title
Muscular Strength - Hand Grip and Leg Strength
Description
Change in upper and lower body strength within and between groups
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks
Title
Disease Activity Score (DAS-28)
Description
Change in disease activity measured using the DAS-28 within and between groups. Scores range from 0 [very well] to 10 [very poor].
Time Frame
Baseline, 8-weeks, 16-weeks and 24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Duke Center for Living
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

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