An interventional study of Evaluation of the Arthritis Foundation Tai Chi Program in Arthritis, sponsored by University of North Carolina, Chapel Hill. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-05.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 358 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Arthritis symptoms.
Arthritis symptoms include pain, stiffness and fatigue as measured using a 10 cm Visual Analog Scale (VAS)
Time frame: 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.
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks from baseline assessment
Secondary outcomes are psychosocial measures.
Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)
Time frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment
No study locations are listed for this record.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill