Evaluation of the Arthritis Foundation Tai Chi Program

This study has been completed.
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Leigh F Callahan, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01184924
First received: August 13, 2010
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Arthritis
Behavioral: Evaluation of the Arthritis Foundation Tai Chi Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Arthritis Foundation Tai Chi Program

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Arthritis symptoms. [ Time Frame: Baseline , 8 weeks from baseline assessment, 1 year from baseline asssessment ] [ Designated as safety issue: No ]
    Arthritis symptoms include pain, stiffness and fatigue as measured using a 10 cm Visual Analog Scale (VAS)

  • Health Assessment Questionnaire (HAQ) [ Time Frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment ] [ Designated as safety issue: No ]
    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 Self Efficacy (ASE) [ Time Frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 8 weeks from baseline assessment, 16 weeks from baseline assessment. ] [ Designated as safety issue: No ]
    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.

  • 50 Foot Walk Test [ Time Frame: Baseline, 8 weeks from baseline assessment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 8 weeks from baseline assessment ] [ Designated as safety issue: No ]
    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.

  • Timed Chair Stands Test [ Time Frame: Baseline, 8 weeks from baseline assessment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 8 weeks from baseline assessment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Secondary outcomes are psychosocial measures. [ Time Frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment ] [ Designated as safety issue: No ]
    Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)


Enrollment: 358
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184924

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Arthritis Foundation
Investigators
Principal Investigator: Leigh F Callahan, PhD University of North Carolina at Chapel Hill, Thurston Arthritis Research Center
  More Information

No publications provided

Responsible Party: Leigh F Callahan, PhD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01184924     History of Changes
Other Study ID Numbers: 08-1048
Study First Received: August 13, 2010
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Arthritis
Tai Chi

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014