OsteoarthritisPhase 1NCT00485043
Effects of Modified T'ai Chi on Symptoms in Older Adults With Osteoarthritis
A Phase 1 study testing Modified T'ai Chi: T'ai Chi for Arthritis in people with Osteoarthritis, run by University of Kansas.
Trial summary
The purpose of this study was to evaluate the effects of TC for Arthritis on physical function, pain, and stiffness in older adults with knee/hip OA. Two hypotheses were tested: 1. Individuals in the TC group will demonstrate greater improvements in physical function compared to control group participants. 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Modified T'ai Chi: T'ai Chi for Arthritis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Apr 2006
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to walk independently,
- Speak and understand English,
- Understand the consent process; and
- Give informed consent.
Who cannot join
- Participation in rehabilitation or another TC class,
- At the time of recruitment; and
- Inability to confirm medical stability for safe participation with healthcare provider.
About this study
Official title: Effects of Modified T'ai Chi Exercise on Physical Function, Pain, and Stiffness in Older Adults With Lower Extremity Osteoarthritis
The purpose of this study was to evaluate the effects of TC for Arthritis on physical function, pain, and stiffness in older adults with knee/hip OA. Two hypotheses were tested:
- Individuals in the TC group will demonstrate greater improvements in physical function compared to control group participants.
- Individuals in the TC group will demonstrate greater decreases in pain and stiffness compared to control group participants.
Read the detailed description
Exercise is considered a vital component of osteoarthritis (OA) treatment. T'ai Chi (TC) is a unique exercise intervention with low-velocity movements. Few studies have addressed the effects of TC on arthritis symptoms and function. TC for Arthritis was modified specifically for people with OA and consists of a standardized set of forms.
The purpose of this study was to evaluate the effectiveness of a low-dose TC for Arthritis on physical function, pain, and stiffness in individuals with OA.
Twenty-seven older adults with OA (mean age-81.3 years) completed an 8 week non-randomized controlled pre-post test quasi-experimental design study of TC for Arthritis. Physical function, pain, and stiffness were measured at baseline and 8 weeks for the TC and control groups using the WOMAC™ 3.1 Index. Qualitative data from interviews and participant observations were analyzed in order to understand the participants' expectations and experiences with TC.
- Conditions
- Osteoarthritis
- Being tested
- Modified T'ai Chi: T'ai Chi for Arthritis
- Keywords
- T'ai Chi, Osteoarthritis, Exercise, Older adults
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified T'ai Chi: T'ai Chi for ArthritisBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function
Measured: 8 weeks
Secondary outcomes (1)
pain and stiffness
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJan 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Investigators
- Cynthia Teel S. Teel, BSN, PhD, Study chair, University of Kansas Medical CenterGeraldine R. Neuberger, BSN, EdD, Study chair, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485043
- Sponsor's protocol ID
- KUMC-JCarpenter dissertation-1
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 12 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified T'ai Chi Exercise on Physical Function, Pain, and Stiffness in Older Adults With Lower Extremity Osteoarthritis
- ClinicalTrials.gov ID
- NCT00485043
- Acronym / sponsor ID
- KUMC-JCarpenter dissertation-1
- Conditions
- Osteoarthritis
- Keywords
- T'ai Chi, Osteoarthritis, Exercise, Older adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Apr 2006 (actual)
- First posted
- 12 Jun 2007 (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 purpose of this study was to evaluate the effects of TC for Arthritis on physical function, pain, and stiffness in older adults with knee/hip OA. Two hypotheses were tested:
- Individuals in the TC group will demonstrate greater improvements in physical function compared to control group participants.
- Individuals in the TC group will demonstrate greater decreases in pain and stiffness compared to control group participants.
Detailed description
Exercise is considered a vital component of osteoarthritis (OA) treatment. T'ai Chi (TC) is a unique exercise intervention with low-velocity movements. Few studies have addressed the effects of TC on arthritis symptoms and function. TC for Arthritis was modified specifically for people with OA and consists of a standardized set of forms.
The purpose of this study was to evaluate the effectiveness of a low-dose TC for Arthritis on physical function, pain, and stiffness in individuals with OA.
Twenty-seven older adults with OA (mean age-81.3 years) completed an 8 week non-randomized controlled pre-post test quasi-experimental design study of TC for Arthritis. Physical function, pain, and stiffness were measured at baseline and 8 weeks for the TC and control groups using the WOMAC™ 3.1 Index. Qualitative data from interviews and participant observations were analyzed in order to understand the participants' expectations and experiences with TC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to walk independently,
- Speak and understand English,
- Understand the consent process; and
- Give informed consent.
Key exclusion criteria (3 listed)
- Participation in rehabilitation or another TC class,
- At the time of recruitment; and
- Inability to confirm medical stability for safe participation with healthcare provider.
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 |
|---|---|---|
| Modified T'ai Chi: T'ai Chi for Arthritis | Behavioural | – |
Primary outcome
physical function
Time frame: 8 weeks
1 secondary outcome
pain and stiffness
Time frame: 8 weeks
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 12 Jun 2007.
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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.
Cynthia Teel S. Teel, BSN, PhD study chair
University of Kansas Medical Center
Geraldine R. Neuberger, BSN, EdD study chair
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modified T'ai Chi: T'ai Chi for Arthritis in people with Osteoarthritis, run by University of Kansas.
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 4 inclusion and 3 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 12 Jun 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
physical function (time frame: 8 weeks). 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 12 Jun 2007.