Rheumatoid Arthritis
Conditions
Keywords
RA Seropositive, RA Erosive, Exercise, Diet, Nutrition, Cardiovascular Risk
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.
Interventions
OTHERSWET: 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.
OTHERCHAT: Counseling Health As Treatment
Control Arm over 16 weeks.
Sponsors
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Syndrome Severity Z-score (MSSc) | Baseline and 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire | Baseline and 16 weeks | Change in patient-reported outcomes using PROMIS Physical Function Questionnaire. The questionnaire was scored using response pattern scoring according to the PROMIS scoring manual in order to calculate the T-score for this outcome measure. The population mean T-score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average. |
| Disease Activity Score (DAS-28) | Baseline and 16 weeks | Change in disease activity measured using the DAS-28. DAS-28 is a composite measure including a self-reported overall health assessment on a 100 mm visual analog scale, the number of tender and swollen joints determined from a 28-joint examination, and C-reactive protein. Scores range from 0 \[very well\] to 10 \[very poor\]. |
Countries
United States
Participant flow
Recruitment details
Participants were primarily recruited from outpatient rheumatology clinics serving Duke Health in North Carolina, USA. Additional recruitment strategies included: paper and electronic advertisements, physician referrals, and the Duke Health and Exercise Research registry.
Pre-assignment details
Of the 26 consented participants, 24 participants met inclusion criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Counseling Health As Treatment (CHAT) CHAT is a control arm designed to reflect traditional clinical counselling.
CHAT: Counseling Health As Treatment: Control Arm over 16 weeks. | 12 |
| Supervised Weight Loss and Exercise Training (SWET) SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session.
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. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Counseling Health As Treatment (CHAT) | Supervised Weight Loss and Exercise Training (SWET) | Total |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 6.2 | 68.1 years STANDARD_DEVIATION 5.8 | 67.6 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 9 Participants | 15 Participants |
| Region of Enrollment United States | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 3 / 12 | 9 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: Baseline and 16 weeks
Population: One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Health As Treatment (CHAT) | Metabolic Syndrome Severity Z-score (MSSc) | Baseline | -1.89 Z-score (unitless) | Standard Deviation 2.39 |
| Counseling Health As Treatment (CHAT) | Metabolic Syndrome Severity Z-score (MSSc) | Week 16 | -3.23 Z-score (unitless) | Standard Deviation 2.8 |
| Supervised Weight Loss and Exercise Training (SWET) | Metabolic Syndrome Severity Z-score (MSSc) | Baseline | -1.82 Z-score (unitless) | Standard Deviation 2.01 |
| Supervised Weight Loss and Exercise Training (SWET) | Metabolic Syndrome Severity Z-score (MSSc) | Week 16 | -3.49 Z-score (unitless) | Standard Deviation 2.28 |
p-value: <0.05Regression, Linear
Secondary
Disease Activity Score (DAS-28)
Change in disease activity measured using the DAS-28. DAS-28 is a composite measure including a self-reported overall health assessment on a 100 mm visual analog scale, the number of tender and swollen joints determined from a 28-joint examination, and C-reactive protein. Scores range from 0 \[very well\] to 10 \[very poor\].
Time frame: Baseline and 16 weeks
Population: One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Health As Treatment (CHAT) | Disease Activity Score (DAS-28) | Baseline | 3.1 score on a scale | Standard Deviation 1 |
| Counseling Health As Treatment (CHAT) | Disease Activity Score (DAS-28) | Week 16 | 2.9 score on a scale | Standard Deviation 0.8 |
| Supervised Weight Loss and Exercise Training (SWET) | Disease Activity Score (DAS-28) | Baseline | 2.9 score on a scale | Standard Deviation 1.2 |
| Supervised Weight Loss and Exercise Training (SWET) | Disease Activity Score (DAS-28) | Week 16 | 2.1 score on a scale | Standard Deviation 0.9 |
p-value: <0.05Regression, Linear
Secondary
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire
Change in patient-reported outcomes using PROMIS Physical Function Questionnaire. The questionnaire was scored using response pattern scoring according to the PROMIS scoring manual in order to calculate the T-score for this outcome measure. The population mean T-score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average.
Time frame: Baseline and 16 weeks
Population: One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Counseling Health As Treatment (CHAT) | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire | Baseline | 41.7 T-score (unitless) | Standard Deviation 5 |
| Counseling Health As Treatment (CHAT) | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire | 16 weeks | 41.7 T-score (unitless) | Standard Deviation 6.4 |
| Supervised Weight Loss and Exercise Training (SWET) | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire | Baseline | 42.3 T-score (unitless) | Standard Deviation 6.3 |
| Supervised Weight Loss and Exercise Training (SWET) | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire | 16 weeks | 48.1 T-score (unitless) | Standard Deviation 6.5 |
p-value: <0.05Regression, Linear