Evaluation of People With Arthritis Can Exercise
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 347
- 主要终点
- Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months
研究概览
简要总结
The primary goal of this study is to assess the effect of People with Arthritis Can Exercise (PACE), a community-based group recreational exercise program, on key arthritis-related health outcomes among adults with arthritis.
详细描述
Self-management is very important in chronic diseases, and promoting physical activity is a key public health strategy for arthritis management. Although several exercise programs such as People with Arthritis Can Exercise (PACE) have been created to implement this strategy, none have sufficient scientific evidence supporting their effectiveness to promote the programs through public health avenues.
The primary goal of this study is to assess the effect of PACE(People with Arthritis Can Exercise), a community-based group recreational exercise program, on key arthritis-related health outcomes. The primary goal of the study will be accomplished through an eight week randomized controlled trial conducted with 480 participants residing in eight urban or rural communities in North Carolina. This project is designed to evaluate the effectiveness of the program in changing arthritis-related health outcomes such as pain, function and physical activity levels. The project will compare the eight week PACE program to a control group.
The specific objectives are as follows: (The aims have not been modified.)
- To further review the PACE conceptual framework and materials in order to develop a standardized PACE protocol to be delivered in the study as well as to refine study measures.
- To work closely with the Carolinas AF Chapter to develop collaborative relationships with local health departments and key contacts in communities identified for PACE implementation.
- To recruit 480 individuals to participate in a randomized controlled trial of PACE in eight communities and to implement the PACE program.
- To compare changes in key arthritis-related health outcomes between PACE participants and controls over eight weeks (PACE course time frame).
- To determine longer-term benefits of the PACE intervention by examining key arthritis-related health outcomes 3 and 6 months post completion of the intervention.
- To conduct qualitative research among PACE completers and non-completers to determine motivators and barriers to success, as well as to determine the acceptability and suitability of the program.
- To formulate recommendations or modifications for implementation of the PACE program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over age 18
- •Have some form of arthritis (examples: osteoarthritis, rheumatoid arthritis, lupus, fibromyalgia, gout, etc.)
- •Be able to move independently without assistance
- •Currently exercising less than 3 times per week
排除标准
- •Inability to walk without assistance
- •Severe health condition where exercise is contraindicated
结局指标
主要结局
Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months
Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months
Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months
Visual Analog Scale pain level at baseline, 2, 3 and 6 months
次要结局
- Visual analog scale stiffness
- Outcomes Expectations for Exercise (OEE)
- Tampa Scale for Kinesiophobia (TSK)
- Visual analog scale fatigue
- Rheumatoid Arthritis Self-efficacy Scale (RASE)
- Center for Epidemiologic Studies Depression Scale (CES-D)
- COnfidence Self-efficacy (CSE)
- Rheumatology Attitudes Index (RAI)