Evaluation of the Arthritis Foundation Tai Chi Program

November 4, 2013 updated by: Leigh F Callahan, PhD, University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Usual Care only. Usual care is defined as the care these subjects would like to seek from any health care practitioner or other program they may seek for healthy living. The subjects in this arm will be offered the AF Tai Chi intervention after an 8 week followup data collection
EXPERIMENTAL: Tai Chi
Usual care plus Tai Chi. These subjects will be allowed to seek care from any health practitioner or any other programs and will receive the AF Tai Chi program for 8 weeks.
Behavioral: Evaluation of the Arthritis Foundation Tai Chi Program
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. Participants will be randomly assigned to the intervention or delayed control arm of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthritis symptoms.
Time Frame: 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)
Baseline , 8 weeks from baseline assessment, 1 year from baseline asssessment
Health Assessment Questionnaire (HAQ)
Time Frame: 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.
Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment
Arthritis Self Efficacy (ASE)
Time Frame: 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"
Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment
Falls Surveillance
Time Frame: 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.
Baseline, 8 weeks from baseline assessment, 16 weeks from baseline assessment.
50 Foot Walk Test
Time Frame: 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.
Baseline, 8 weeks from baseline assessment
Multidirectional Reach Test
Time Frame: 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.
Baseline, 8 weeks from baseline assessment
Timed Chair Stands Test
Time Frame: 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.
Baseline, 8 weeks from baseline assessment
Single Leg Stance (SLS)
Time Frame: 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.
Baseline, 8 weeks from baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes are psychosocial measures.
Time Frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment
Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)
Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Arthritis Foundation

Investigators

  • Principal Investigator: Leigh F Callahan, PhD, University of North Carolina at Chapel Hill, Thurston Arthritis Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 13, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (ESTIMATE)

August 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-1048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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