Evaluation of the Arthritis Foundation Tai Chi Program

Arthritis Clinical Trial

Official title:

Evaluation of the Arthritis Foundation Tai Chi Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184924
• Other study ID #: 08-1048
• Status: Completed
• Phase: N/A
• First received: August 13, 2010
• Last updated: November 4, 2013
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: August 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Arthritis Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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.	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Secondary outcomes are psychosocial measures.	Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)	Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment	No