The aim of this study is to determine, in the framework of a randomized controlled clinical trial, whether Tai Chi can effect measurable improvements in self-reported outcomes such as pain, physical function and psychological well-being in people with 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 TaiChi 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.

Condition	Intervention
Osteoarthritis, Hip Osteoarthritis, Knee	Behavior: Tai Chi classes  Behavior: Hydrotherapy classes

Further Study Details: 

Primary Outcomes: Self-reported pain and function (WOMAC)
Secondary Outcomes: General health status (SF-36); Psychological well being (DASS); Patient global assessment (100mm VAS).; Physical performance: 50ft walktime, stair time.
Expected Total Enrollment:  150

A single blinded randomized controlled clinical trial with 3 allocation groups. 1. Tai Chi: maximum 15 people per group, twice weekly, 12 weeks. 2. Hydrotherapy: maximum 15 people per group, twice weekly, 12 weeks. 3. 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.

Ages Eligible for Study:  59 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Symptomatic osteoarthritis of the hip(s) or knee(s) according to ACR clinical and radiographic (hip) criteria.

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.

Australia, New South Wales
      St George Hospital, Kogarah,  New South Wales,  2217,  Australia

Study chairs or principal investigators

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   

Study ID Numbers:  NAMCIG56; RFP 95/0203
Last Updated:  August 1, 2005
Record first received:  July 25, 2005
ClinicalTrials.gov Identifier:  NCT00123994
Health Authority: Australia: Human Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-02