Evaluation of the Arthritis Foundation Tai Chi Program
Primary Purpose
Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evaluation of the Arthritis Foundation Tai Chi Program
Sponsored by
About this trial
This is an interventional prevention trial for Arthritis focused on measuring Arthritis, Tai Chi
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Tai Chi
Arm Description
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.
Outcomes
Primary Outcome Measures
Arthritis symptoms.
Arthritis symptoms include pain, stiffness and fatigue as measured using a 10 cm Visual Analog Scale (VAS)
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.
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"
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.
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.
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.
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.
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.
Secondary Outcome Measures
Secondary outcomes are psychosocial measures.
Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)
Full Information
NCT ID
NCT01184924
First Posted
August 13, 2010
Last Updated
November 4, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Arthritis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01184924
Brief Title
Evaluation of the Arthritis Foundation Tai Chi Program
Official Title
Evaluation of the Arthritis Foundation Tai Chi Program
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Arthritis Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
Arthritis, Tai Chi
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of the Arthritis Foundation Tai Chi Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arthritis symptoms.
Description
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
Title
Health Assessment Questionnaire (HAQ)
Description
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
Title
Arthritis Self Efficacy (ASE)
Description
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
Title
Falls Surveillance
Description
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.
Title
50 Foot Walk Test
Description
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
Title
Multidirectional Reach Test
Description
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
Title
Timed Chair Stands Test
Description
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
Title
Single Leg Stance (SLS)
Description
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 Outcome Measure Information:
Title
Secondary outcomes are psychosocial measures.
Description
Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)
Time Frame
Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh F Callahan, PhD
Organizational Affiliation
University of North Carolina at Chapel Hill, Thurston Arthritis Research Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Arthritis Foundation Tai Chi Program
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