ArthritisNCT01184924
Evaluation of the Arthritis Foundation Tai Chi Program
A study testing Evaluation of the Arthritis Foundation Tai Chi Program in people with Arthritis, run by University of North Carolina, Chapel Hill.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- Evaluation of the Arthritis Foundation Tai Chi Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-Reported doctor diagnosed arthritis
- Age 18 years or older
- Able to move independently without assistance
Who cannot join
- 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
About this study
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
- Being tested
- Evaluation of the Arthritis Foundation Tai Chi Program
- Keywords
- Arthritis, Tai Chi
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the Arthritis Foundation Tai Chi ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Evaluation of the Arthritis Foundation Tai Chi Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis symptoms.
Arthritis symptoms include pain, stiffness and fatigue as measured using a 10 cm Visual Analog Scale (VAS)
Measured: 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.
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks from baseline assessment
Secondary outcomes (1)
Secondary outcomes are psychosocial measures.
Psychosocial measures include: Rheumatology Attitudes Index (RAI, helplessness)
Measured: Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Leigh F Callahan, PhD, University of North Carolina, Chapel Hill
- Investigators
- Leigh F Callahan, PhD, Principal investigator, University of North Carolina at Chapel Hill, Thurston Arthritis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184924
- Sponsor's protocol ID
- 08-1048
- Status last verified
- Nov 2013
- First submitted
- 13 Aug 2010
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Arthritis Foundation Tai Chi Program
- ClinicalTrials.gov ID
- NCT01184924
- Acronym / sponsor ID
- 08-1048
- Conditions
- Arthritis
- Keywords
- Arthritis, Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Evaluation of the Arthritis Foundation Tai Chi ProgramUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-Reported doctor diagnosed arthritis
- Age 18 years or older
- Able to move independently without assistance
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the Arthritis Foundation Tai Chi ProgramThe 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. | Behavioural | Tai Chi |
Primary outcome
Arthritis symptoms.
Time frame: Baseline , 8 weeks from baseline assessment, 1 year from baseline asssessment
Arthritis symptoms include pain, stiffness and fatigue as measured using a 10 cm Visual Analog Scale (VAS)
Health Assessment Questionnaire (HAQ)
Time frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment
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)
Time frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline asssessment
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
Time frame: Baseline, 8 weeks from baseline assessment, 16 weeks from baseline assessment.
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
Time frame: Baseline, 8 weeks from baseline assessment
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
Time frame: Baseline, 8 weeks from baseline assessment
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
Time frame: Baseline, 8 weeks from baseline assessment
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)
Time frame: Baseline, 8 weeks from baseline assessment
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.
1 secondary outcome
Secondary outcomes are psychosocial measures.
Time frame: Baseline, 8 weeks from baseline assessment, 1 year from baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh F Callahan, PhD principal investigator
University of North Carolina at Chapel Hill, Thurston Arthritis Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the Arthritis Foundation Tai Chi Program in people with Arthritis, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthritis symptoms. (time frame: Baseline , 8 weeks from baseline assessment, 1 year from baseline asssessment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.