Rheumatoid ArthritisNCT00522054
Tai Chi for Patients With Rheumatoid Arthritis
A study testing Physical exercise in people with Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
The purpose of this study was to study the impact of Tai Chi group exercise on physical function, health and disease activity of patients with RA, and to examine the patients' experience and perception of Tai Chi. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2004to Mar 2005
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA according to the American College of Rheumatology (ACR) 1987
- Stable medical treatment
- No earlier experience with Tai Chi
Who cannot join
- Lack of ability to bear weight on the lower extremities
- Recent or ongoing disease flare
- Unstable heart condition
- Participation in other physical exercise interventions more than twice a week included in other intervention studies.
Trial locations and contacts
1 site in 1 country.
Norway1 site
National resource center for rehabilitation in rheumatology. Diakonhjemmet Hospital
Oslo, Oslo, 0319
About this study
Official title: Tai Chi for Patients With Rheumatoid Arthritis: A Quantitative and Qualitative Study
The purpose of this study was to study the impact of Tai Chi group exercise on physical function, health and disease activity of patients with RA, and to examine the patients' experience and perception of Tai Chi.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, inflammatory and systemic disease that mainly affects the musculoskeletal system. The disease is often progressive and may result in reduced physical function, pain, fatigue, and joint destruction. Exercise programs are reported to improve physical functioning in patients with RA.
Tai Chi is a traditional Chinese martial art that was developed in the 13th century, and combines slow and gentle movements with mental focus.
The aim of this study was to examine the impact of a 12 weeks standardized Tai Chi group exercise program on disease activity, physical function and health status in patients with RA attending. Further, the patients experiences of possible effects of Tai Chi were to be obtained in a focus group interview.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Physical exercise
- Keywords
- Exercise, Physical function, Rheumatoid arthritis, Tai Chi
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Tai Chi exercise, twice a week during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Single group study Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance was measured with Walking in a Figure of Eight. Strength and endurance were measured by Timed-Stands test. Shoulder function was measured with Assessments of Shoulder Movement Impairment Scale.
Measured: 15 min
Secondary outcomes (3)
Blood samples were collected for determination of sedimentation rate (ESR) and C-reactive protein (CRP). A rheumatologist examined the patients with the number of 28 swollen and tender joints.
Measured: 15 min
Self-reported health status included Health Assessment Questionnaire, visual analogue scale for fatigue, muscle pain, and fear of falling, Short Form Health Survey and Arthritis Self-Efficacy Scale
Measured: 15 min
Focus group interview in order to capture the participants' experiences and perceptions with Tai Chi.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startSep 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Camilla Fongen, MSc, Study chair, National Resource Center for Rehabilitation in Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522054
- Sponsor's protocol ID
- 587-03244
- Status last verified
- Aug 2007
- First submitted
- 27 Aug 2007
- Last updated
- 29 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Uhlig T, Fongen C, Steen E, Christie A, Odegard S. Exploring Tai Chi in rheumatoid arthritis: a quantitative and qualitative study. BMC Musculoskelet Disord. 2010 Mar 5;11:43. doi: 10.1186/1471-2474-11-43.
PubMed 20205741
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Patients With Rheumatoid Arthritis: A Quantitative and Qualitative Study
- ClinicalTrials.gov ID
- NCT00522054
- Acronym / sponsor ID
- 587-03244
- Conditions
- Rheumatoid Arthritis
- Keywords
- Exercise, Physical function, Rheumatoid arthritis, Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 29 Aug 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 study the impact of Tai Chi group exercise on physical function, health and disease activity of patients with RA, and to examine the patients' experience and perception of Tai Chi.
Detailed description
Rheumatoid arthritis (RA) is a chronic, inflammatory and systemic disease that mainly affects the musculoskeletal system. The disease is often progressive and may result in reduced physical function, pain, fatigue, and joint destruction. Exercise programs are reported to improve physical functioning in patients with RA.
Tai Chi is a traditional Chinese martial art that was developed in the 13th century, and combines slow and gentle movements with mental focus.
The aim of this study was to examine the impact of a 12 weeks standardized Tai Chi group exercise program on disease activity, physical function and health status in patients with RA attending. Further, the patients experiences of possible effects of Tai Chi were to be obtained in a focus group interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: Physical exerciseSingle group study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of RA according to the American College of Rheumatology (ACR) 1987
- Stable medical treatment
- No earlier experience with Tai Chi
Key exclusion criteria (4 listed)
- Lack of ability to bear weight on the lower extremities
- Recent or ongoing disease flare
- Unstable heart condition
- Participation in other physical exercise interventions more than twice a week included in other intervention studies.
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 |
|---|---|---|
| Physical exerciseTai Chi exercise, twice a week during 12 weeks | Other | A |
Primary outcome
Balance was measured with Walking in a Figure of Eight. Strength and endurance were measured by Timed-Stands test. Shoulder function was measured with Assessments of Shoulder Movement Impairment Scale.
Time frame: 15 min
3 secondary outcomes
Blood samples were collected for determination of sedimentation rate (ESR) and C-reactive protein (CRP). A rheumatologist examined the patients with the number of 28 swollen and tender joints.
Time frame: 15 min
Self-reported health status included Health Assessment Questionnaire, visual analogue scale for fatigue, muscle pain, and fear of falling, Short Form Health Survey and Arthritis Self-Efficacy Scale
Time frame: 15 min
Focus group interview in order to capture the participants' experiences and perceptions with Tai Chi.
Time frame: 1 hour
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 29 Aug 2007.
- Derived from this study: PubMed 20205741Uhlig T, Fongen C, Steen E, Christie A, Odegard S. Exploring Tai Chi in rheumatoid arthritis: a quantitative and qualitative study. BMC Musculoskelet Disord. 2010 Mar 5;11:43. doi: 10.1186/1471-2474-11-43.
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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.
Camilla Fongen, MSc study chair
National Resource Center for Rehabilitation in Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
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 4 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 29 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Balance was measured with Walking in a Figure of Eight. Strength and endurance were measured by Timed-Stands test. Shoulder function was measured with Assessments of Shoulder Movement Impairment Scale. (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522054, which also lists 1 linked publication.
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 29 Aug 2007.