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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00123994




Registration number
NCT00123994
Ethics application status
Date submitted
22/07/2005
Date registered
26/07/2005
Date last updated
3/11/2005

Titles & IDs
Public title
Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Scientific title
Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Secondary ID [1] 0 0
RFP 95/0203
Secondary ID [2] 0 0
NAMCIG56
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Hip 0 0
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Self-reported pain and function (WOMAC)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
General health status (SF-36)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Psychological well being (DASS)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Patient global assessment (100mm visual analogue scale [VAS])
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Physical performance: 50 feet walk time, stair time
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
* Symptomatic osteoarthritis of the hip(s) or knee(s) according to American College of Rheumatology (ACR) clinical and radiographic (hip) criteria.
Minimum age
59 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Australian Government Department of Health and Ageing
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St George Division of General Practice, NSW, Australia.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of New South Wales
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT00123994
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Marlene H Fransen, PhD MPH
Address 0 0
The George Institute, University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00123994