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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
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis focused on measuring Arthritis, Tai Chi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 13, 2010
    Last Updated
    November 4, 2013
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Arthritis Foundation
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    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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