Osteoarthritis, HipNCT00123994
Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
A study testing Tai Chi classes and Hydrotherapy classes in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by St George Hospital, Australia at 1 site in Australia.
Trial summary
The aim of this study is to determine, in the framework of a randomized controlled clinical trial, whether Tai Chi can affect measurable improvements in self-reported outcomes such as pain, physical function and psychological well-being in people with osteoarthritis (OA) mainly affecting the hips or knees. Read more about this study
- Who is it for?
- Ages 59 to 85 years
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- Tai Chi classes and Hydrotherapy classes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2004to Oct 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 59 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the hip(s) or knee(s) according to American College of Rheumatology (ACR) clinical and radiographic (hip) criteria.
Who cannot join
- Currently participating in recreational physical activity more than twice a week.
- Unable to walk indoors for more than 10 minutes without a walking aid.
- Unable to exercise at a moderate level due to major co-morbidity.
- Incontinent, afraid of water or uncontrolled epilepsy.
- Low back pain referring to limbs.
- Joint replacement surgery in past year.
- Arthroscopic surgery or intra-articular injections in knee or hip in past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine, in the framework of a randomized controlled clinical trial, whether Tai Chi can affect measurable improvements in self-reported outcomes such as pain, physical function and psychological well-being in people with osteoarthritis (OA) mainly affecting the hips or knees. The effectiveness of Tai Chi will be compared with both a non-intervention control group as well as with a formal exercise program, hydrotherapy. Hydrotherapy has long been considered an effective intervention for people with chronic OA although scientific evidence is weak at present. The main study hypotheses are that Tai Chi or hydrotherapy can significantly decrease pain and physical limitations; improve health-related quality of life; and promote psychological well being in patients with OA of the hip(s) or knee(s); and that Tai Chi and hydrotherapy are of equal efficacy.
Read the detailed description
A single blinded randomized controlled clinical trial with 3 allocation groups:
- Tai Chi: maximum 15 people per group, twice weekly, 12 weeks.
- Hydrotherapy: maximum 15 people per group, twice weekly, 12 weeks.
- Control: 12 weeks waiting time prior to allocation to active intervention.
A specially designed Tai Chi program (Tai Chi for Arthritis, Paul Lam) will be provided in a community setting by trained instructors. Hydrotherapy sessions will be held at the St. George Hospital under supervision of registered physiotherapists with rheumatology and hydrotherapy experience.
Outcomes will be measured twice: 12 and 24 weeks after randomisation.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- Tai Chi classes, Hydrotherapy classes
- Keywords
- TaiChi, Hydrotherapy, Exercise, Joint pain, Disability
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee, Motor Activity, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi classesBehavioural
Hydrotherapy classesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain and function (WOMAC)
Secondary outcomes (4)
General health status (SF-36)
Psychological well being (DASS)
Patient global assessment (100mm visual analogue scale [VAS])
Physical performance: 50 feet walk time, stair time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startFeb 2004
- Study completionOct 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 Osteoarthritis, HipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing, St George Division of General Practice, NSW, Australia., The University of New South Wales
- Investigators
- Marlene H Fransen, PhD MPH, Principal investigator, The George Institute, University of SydneyJohn Edmonds, MB, BS, Study chair, St George Hospital, University of NSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123994
- Sponsor's protocol ID
- NAMCIG56
- Other IDs
- RFP 95/0203
- Status last verified
- Jul 2005
- First submitted
- 22 Jul 2005
- Last updated
- 3 Nov 2005
- Results posted
- No
Publications
Fransen M, Nairn L, Winstanley J, Lam P, Edmonds J. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes. Arthritis Rheum. 2007 Apr 15;57(3):407-14. doi: 10.1002/art.22621.
PubMed 17443749
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
- ClinicalTrials.gov ID
- NCT00123994
- Acronym / sponsor ID
- NAMCIG56
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- TaiChi, Hydrotherapy, Exercise, Joint pain, Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing, St George Division of General Practice, NSW, Australia., The University of New South Wales
- Study start
- Feb 2004
- Study completion
- Oct 2005
- First posted
- 26 Jul 2005 (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 aim of this study is to determine, in the framework of a randomized controlled clinical trial, whether Tai Chi can affect measurable improvements in self-reported outcomes such as pain, physical function and psychological well-being in people with osteoarthritis (OA) mainly affecting the hips or knees. The effectiveness of Tai Chi will be compared with both a non-intervention control group as well as with a formal exercise program, hydrotherapy. Hydrotherapy has long been considered an effective intervention for people with chronic OA although scientific evidence is weak at present. The main study hypotheses are that Tai Chi or hydrotherapy can significantly decrease pain and physical limitations; improve health-related quality of life; and promote psychological well being in patients with OA of the hip(s) or knee(s); and that Tai Chi and hydrotherapy are of equal efficacy.
Detailed description
A single blinded randomized controlled clinical trial with 3 allocation groups:
- Tai Chi: maximum 15 people per group, twice weekly, 12 weeks.
- Hydrotherapy: maximum 15 people per group, twice weekly, 12 weeks.
- Control: 12 weeks waiting time prior to allocation to active intervention.
A specially designed Tai Chi program (Tai Chi for Arthritis, Paul Lam) will be provided in a community setting by trained instructors. Hydrotherapy sessions will be held at the St. George Hospital under supervision of registered physiotherapists with rheumatology and hydrotherapy experience.
Outcomes will be measured twice: 12 and 24 weeks after randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 59 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic osteoarthritis of the hip(s) or knee(s) according to American College of Rheumatology (ACR) clinical and radiographic (hip) criteria.
Key exclusion criteria (7 listed)
- Currently participating in recreational physical activity more than twice a week.
- Unable to walk indoors for more than 10 minutes without a walking aid.
- Unable to exercise at a moderate level due to major co-morbidity.
- Incontinent, afraid of water or uncontrolled epilepsy.
- Low back pain referring to limbs.
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 |
|---|---|---|
| Tai Chi classes | Behavioural | – |
| Hydrotherapy classes | Behavioural | – |
Primary outcome
Self-reported pain and function (WOMAC)
4 secondary outcomes
General health status (SF-36)
Psychological well being (DASS)
Patient global assessment (100mm visual analogue scale [VAS])
Physical performance: 50 feet walk time, stair time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2005.
- Derived from this study: PubMed 17443749Fransen M, Nairn L, Winstanley J, Lam P, Edmonds J. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes. Arthritis Rheum. 2007 Apr 15;57(3):407-14. doi: 10.1002/art.22621.
Related trials for Osteoarthritis, Hip
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.
Marlene H Fransen, PhD MPH principal investigator
The George Institute, University of Sydney
John Edmonds, MB, BS study chair
St George Hospital, University of NSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi classes and Hydrotherapy classes in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by St George Hospital, Australia at 1 site in Australia.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Nov 2005. 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 Australia. 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?
Results are not available in the source record.
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?
Self-reported pain and function (WOMAC). 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 NCT00123994, 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 3 Nov 2005.