Evaluation of the Arthritis Foundation Tai Chi Program

NCT01184924 | Completed

• 1 other identifier: 08-1048
• Study Type: interventional
• Target: 358
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Arthritis

Keywords

Arthritis; Tai Chi

Outcome Measures

Primary Outcomes (8)

• Arthritis symptoms.

  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)

  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)

  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

  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

  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

  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

  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)

  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 Outcomes (1)

• Secondary outcomes are psychosocial measures.

  Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment

Study Arms (2)

Control

NO INTERVENTION

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

Tai Chi

EXPERIMENTAL

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

Interventions

Evaluation of the Arthritis Foundation Tai Chi Program BEHAVIORAL

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.

Tai Chi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Arthritis Foundation: collaborator

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Leigh F Callahan, PhD

  University of North Carolina at Chapel Hill, Thurston Arthritis Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 19, 2010
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2011
• Last Updated: November 5, 2013

Record last verified: 2013-11