Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
2 other identifiers
interventional
150
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 22, 2005
CompletedFirst Posted
Study publicly available on registry
July 26, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedNovember 3, 2005
July 1, 2005
July 22, 2005
November 2, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Symptomatic osteoarthritis of the hip(s) or knee(s) according to American College of Rheumatology (ACR) clinical and radiographic (hip) criteria.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St George Hospital
Kogarah, New South Wales, 2217, Australia
Related Publications (1)
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.
PMID: 17443749DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlene H Fransen, PhD MPH
The George Institute, University of Sydney
- STUDY CHAIR
John Edmonds, MB, BS
St George Hospital, University of NSW
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 22, 2005
First Posted
July 26, 2005
Study Start
February 1, 2004
Study Completion
October 1, 2005
Last Updated
November 3, 2005
Record last verified: 2005-07