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临床试验/NCT01184924
NCT01184924已完成不适用

Evaluation of the Arthritis Foundation Tai Chi Program

University of North Carolina, Chapel Hill0 个研究点目标入组 358 人开始时间: 2008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
358
主要终点
Health Assessment Questionnaire (HAQ)

研究概览

简要总结

The primary goal of this study is to assess the effectiveness and feasibility of the arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most prevalent chronic condition in the US and a leading cause of disability, is characterized by chronic pain and progressive impairment of joints and soft tissues. Promoting physical activity is a key public health strategy to addressing arthritis management, but more scientific data regarding effectiveness and feasibility are need to support the promotion of the AF Tai Chi Program as an exercise intervention for people with 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
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

入选标准

  • Self-Reported doctor diagnosed arthritis
  • Age 18 years or older
  • Able to move independently without assistance

排除标准

  • Pregnancy
  • Non-English speaking
  • Cognitive impairment
  • Serious medical conditions: History of MI, stroke, prescribed beta-blockers, surgery in past 6 months, uncontrolled hypertension, chest pain, diabetes mellitus
  • Severe impairment of physical functioning
  • Participation in Tai Chi exercise in last 3 months

结局指标

主要结局

Health Assessment Questionnaire (HAQ)

时间窗: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment

The disability scale of the HAQ will be used to assess physical functioning and disease progression. As a disease specific measure it is used in much of the rheumatological literature. It includes items querying 20 specific activities of daily living in 8 domains (dressing, arising, eating, walking, hygiene, activities, ready, grip) and adjusts scores based on the use of assistive devices. The HAQ is scored from 0 to 3, with 0 representing no disability and 3 representing maximum disability.

Arthritis symptoms.

时间窗: Baseline , 8 weeks from baseline assessment, 1 year from baseline asssessment

Arthritis symptoms include pain, stiffness and fatigue as measured using a 10 cm Visual Analog Scale (VAS)

50 Foot Walk Test

时间窗: Baseline, 8 weeks from baseline assessment

This is an objective measure of submaximal walking function in older adults with arthritis. It was developed to be an outcome measure of physical function for subjects participating in pharmacological clinical trials of arthritis medications.

Multidirectional Reach Test

时间窗: Baseline, 8 weeks from baseline assessment

This test is a balance test developed to study falls in the elderly. Performed while either sitting or standing, (feet comfortably apart) subjects reach in either a forward, backward or sideways direction. Distances reached are measured in inches. The tool has high inter-rater reliability (ICC=.99) and test-retest reliability (ICC-.98) The tool has been shown to have a concurrent validity with the Berg Balance and Timed up and Go Tests.

Arthritis Self Efficacy (ASE)

时间窗: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment

Self-efficacy for managing arthritis will be assessed using two subscales from the Arthritis Self Efficacy Scale developed by Lorig and colleagues. The scale assess the degree to which an individual feels confident about his or her ability to manage his or her arthritis including decreasing pain, keeping pain from interfering with normal activities, and dealing with frustration of having arthritis. The pain subscale (5 items) and the other symptoms subscale (6 items) will be used. The items are scored on a Likert-type scale with 0= "very uncertain" and 100= "very certain"

Falls Surveillance

时间窗: Baseline, 8 weeks from baseline assessment, 16 weeks from baseline assessment.

Adapting a previously used method to the particular schedule of this protocol, both intervention and control participants will be given a "falls calendar" at baseline and instructed to record each day for 16 weeks if they had a fall. Falls are defined as "unintentially coming to rest on the floor or ground". This record will cover the intervention group through the 8 week Tai Chi course and or an 8 week follow up period. The control group record will cover the 8 weeks before Tai Chi and during the delayed Tai Chi course. The calendars will be mailed in after completion.

Timed Chair Stands Test

时间窗: Baseline, 8 weeks from baseline assessment

This test is a functional strength test. It tests the coordinated control of the body's center of mass in order to maintain dynamic balance as the base of support is transitioned from sitting on a chair with feet on the ground (3-point) to standing (2 point). Test-retest reliability has been show to be ICC=.84 for men and .92 for women. It has also shown to have concurrent validity with maximum weight adjusted leg press performance.

Single Leg Stance (SLS)

时间窗: Baseline, 8 weeks from baseline assessment

This is a timed test which has been correlated with amplitude and speed of sway in individuals without disease. The ability to maintain SLS generally decreases with increasing age. The test is performed with eyes open, and subjects stand on one leg while placing arms across their chest.

次要结局

  • Secondary outcomes are psychosocial measures.(Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment)

研究者

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

Leigh F Callahan, PhD

Professor

University of North Carolina, Chapel Hill

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