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临床试验/NCT01172327
NCT01172327已完成不适用

Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis

University of South Carolina2 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
401
试验地点
2
主要终点
Lower body strength

研究概览

简要总结

The purpose of this study is to examine the effectiveness and safety of a self-directed physical activity program relative to a self-directed dietary program in adults with arthritis. A process evaluation will also be conducted to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction.

详细描述

Physical activity is a critical component of arthritis disease management. It also reduces the risk for other chronic comorbid conditions in people with arthritis. Yet, most adults with arthritis are not sufficiently active at the level needed to achieve benefits. Existing group-based arthritis exercise programs reach only a very small percentage of the population. The overall purpose of this study is to test a self-directed and low-cost multicomponent physical activity program for people with arthritis on outcomes including symptoms of arthritis, lower body strength, functional aerobic capacity, flexibility, physical activity, arthritis self-efficacy and disability, upper body strength, balance, gait, and depressive symptoms. The second primary aim is to evaluate the safety of the physical activity program. The third primary aim is to conduct a process evaluation to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction. Adults aged 18 years and older with arthritis will be recruited from the midlands area of South Carolina. After completion of a baseline visit, participants will be randomized in equal numbers to the 12-week physical activity program (First Step to Active Health®) or the 12-week attention-control group (Steps to Healthy Eating). The attention control intervention will have the same "look and feel" as the physical activity intervention and will require similar activities such as self-monitoring of behavior. Follow-up measurements will take place post-program (12-weeks) and 6 months post-program (i.e., 9 months post-randomization). If First Step to Active Health® is shown to be effective, it could be widely disseminated for a very low cost, thus having the potential to make a tremendous public health impact on the burden of arthritis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported, health care provider-diagnosed arthritis (CDC definition)
  • 18+ years of age
  • Self-reported symptoms of joint pain, stiffness, tenderness, decreased range of motion, redness and warmth, deformity, crackling or grating, or fatigue
  • Able to read and write in English

排除标准

  • Another member of household is participating in study
  • Plans to move from the Columbia, SC area in the next 9 months
  • Unable to walk longer than 3 minutes without taking a rest
  • Unable to stand without assistance for more than 2 minutes
  • Cannot sit in a chair without arms for more than 5 minutes
  • Measured resting blood pressure >160/100
  • Positive response to PAR-Q question(s)
  • Had a fall in the past year that required medical assistance
  • Pregnant or breastfeeding
  • Uses insulin to manage diabetes
  • Participating in another research study that includes an intervention or drug
  • Participates in 3+ days of structured moderate-intensity exercise for 30+ minutes per day
  • Participates in 2+ days of strength building exercises for 20+ minutes per day

结局指标

主要结局

Lower body strength

时间窗: 12 weeks

The 30-second chair stand will assess lower body strength.

Symptoms of arthritis

时间窗: 12 weeks

Visual numeric scales to assess pain, fatigue, and stiffness

Functional exercise capacity

时间窗: 12 weeks

The six-minute walk will assess functional exercise capacity

Flexibility

时间窗: 12 weeks

The sit-and-reach test will assess flexibility

Physical activity

时间窗: 12 weeks

The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation

Arthritis management self-efficacy

时间窗: 12 weeks

The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms

次要结局

  • Depressive symptoms(12 weeks)
  • Disability(12 weeks)
  • Balance(12 weeks)
  • Gait(12 weeks)
  • Upper body strength(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Wilcox

Professor

University of South Carolina

研究点 (2)

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