Rheumatoid Arthritis Coping Enhancement

Not Applicable

Completed

• Conditions: Obesity; Rheumatoid Arthritis; Pain
• Interventions: Behavioral: Enhanced Lifestyle Weight Management

• Registration Number: NCT04246827
• Lead Sponsor: Duke University

Brief Summary

This study will test an enhanced lifestyle behavioral weight management program that integrates pain coping strategies with a lifestyle intervention that we expect to enhance obese RA patient's ability to cope with pain-related weight challenges. In the proposed study, up to 120 obese (RA-BMI \> 28) rheumatoid arthritis patients will be consented in order to randomly assign 80 patients to one of two conditions: 1) an Enhanced Lifestyle Weight Management protocol or 2) standard care control. Patients randomized to the Enhanced Lifestyle Weight Management condition will participate in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors will be integrated into a lifestyle behavioral weight loss intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-07
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Study First Posted: 2020-01-29
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• had RA for at least one year
• were 18 to 85 years of age
• were obese according to established RA obesity criteria (RA-BMI > 28)
• had experienced RA pain in the last two weeks.

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Exclusion Criteria

• Subjects were excluded if they 1) have a significant rheumatic disorder other than RA or another organic disease that would significantly affect functioning (e.g., COPD, cancer)
• had a significant medical condition that would expose them to increased risk of a significantly adverse experience during the course of the study (e.g., a recent myocardial infarction)
• they were already involved in a regular exercise program and/or pain coping skills training program
• they had an abnormal cardiac response to exercise such as exercise-induced VT, abnormal blood pressure response, etc.,
• are pregnant at enrollment or at the initiation of intervention
• are younger than 18 years of age or older than 85 years of age
• are known or judged by the physician to be cognitively impaired (dementia, retardation, psychosis)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Lifestyle Weight Management Condition	Enhanced Lifestyle Weight Management	The Enhanced Lifestyle Weight Management condition participants participated in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors was integrated into a lifestyle behavioral weight loss intervention.

Primary Outcome Measures

Name	Time	Method
Change in weight	baseline and post-treatment (12-weeks later)	Participants' weight was obtained.
Change in waist circumference	baseline and post-treatment (12-weeks later)	Participants' waist circumference was measured with a standard measuring tape.
Change in pain as measured by the Brief Pain Inventory	baseline and post-treatment (12-weeks later)	Pain was assessed with the Brief Pain Inventory, which includes four items asking subjects to rate their usual, worst, least, and average pain during the last week. For each item, patients rate their pain using a scale ranging from 1 to 10 with 1 representing "no pain" and 10 representing "pain as bad as you can imagine."
Change in body mass index	baseline and post-treatment (12-weeks later)	Participants' body mass index was calculated by dividing weight (in kg) by height (in m2)
Change in Physical Disability	baseline and post-treatment (12-weeks later)	Participants completed the physical functioning scales of the revised Arthritis Impact Scales (AIMS-2). The AIMS-2 assesses the health status of arthritis patients. Scores range from 0 to 10 with 10 representing reduced physical functioning.
Change in Psychological Disability	baseline and post-treatment (12-weeks later)	Participants completed the psychological functioning scale of the revised Arthritis Impact Scales (AIMS-2). The AIMS-2 assesses the health status of arthritis patients. Scores range from 0 to 10 with 10 representing reduced physical functioning.
Change in C-Reactive Protein	baseline and post-treatment (12-weeks later)	Serum samples were collected for CRP analysis. All blood specimens were collected in the morning and prior to exercise, centrifuged at 3500 rpm for 10 minutes, and serum stored at -80 degrees Celsius until analysis. CRP is an index of inflammation and activity in RA and is thought to be a more specific measure than erythrocyte sedimentation rate.
Change in Cyclic citrullinated peptide (CCP) antibody	baseline and post-treatment (12-weeks later)	Cyclic cirtrullinated peptide (CCP) antibody test that is increasingly being used to measure rheumatoid arthritis disease activity, was collected from the eBrowser when available.

Secondary Outcome Measures

Name	Time	Method
Change in physical disability	baseline and post-treatment (12-weeks later)	The 6 minute walk test was used as an objective assessment of physical disability. This was performed indoors in our lab space, along a long, flat, straight, enclosed corridor. A starting line which marks the beginning and end of each lap was marked on the floor with a brightly colored tape.
Change in rheumatologist Pain Assessment	baseline and post-treatment (12-weeks later)	The study rheumatologist completed a visual analog scale (VAS) for pain assessment. The VAS was a horizontal line 100 mm in length with anchors ranging from 0 "no disease activity" to 100 "high disease activity."
Change in joint symptoms	baseline and post-treatment (12-weeks later)	Two joint counts-of tenderness to palpation and of swelling-were obtained by the examining rheumatologist. As suggested by Fuchs and Pincus, we used a reduced count of 28 joints, and counts rather than grading of tenderness and swelling were made, as advocated by Felson et al. (29), to increase inter-observer reliability.
Change in grip strength	baseline and post-treatment (12-weeks later)	Grip strength was assessed using a sphygmomanometer bulb specially designed for this purpose. Three trials with each hand were conducted, with the average of the three being the person's score.
Change in medication use	baseline and post-treatment (12-weeks later)	A structured interview was carried out by the study rheumatologist at each evaluation to assess subjects' intake of medication. Subjects were asked what medications they have taken in the two weeks prior to the evaluation. Changes in intake of five categories of medication were scored by comparing data with that collected prior to treatment. The categories included will be 1) nonsteroidal anti-inflammatory drugs, 2) non-narcotic analgesics, 3) narcotics, 4) steroids, and 5) disease modifying anti-rheumatic drugs. Changes in medication were scored as dose increased, dose unchanged, or dose decreased. Based on prior research, we do not anticipate significant changes in medication to occur over the course of the study.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States