Rheumatoid Arthritis Coping Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Change in weight
时间窗: baseline and post-treatment (12-weeks later)
Participants' weight was obtained.
Change in waist circumference
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in physical disability(baseline and post-treatment (12-weeks later))
- Change in rheumatologist Pain Assessment(baseline and post-treatment (12-weeks later))
- Change in joint symptoms(baseline and post-treatment (12-weeks later))
- Change in grip strength(baseline and post-treatment (12-weeks later))
- Change in medication use(baseline and post-treatment (12-weeks later))