Clinical trial NCT00123994: Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Official title: Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee
Keywords: TaiChi
Hydrotherapy
Exercise
Joint pain
Disability
Lead sponsor: St George Hospital, Australia
Sponsor class: OTHER
Collaborators: name: Australian Government Department of Health and Ageing
name: St George Division of General Practice, NSW, Australia.
name: The University of New South Wales
First posted: 2005-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 59
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the hip(s) or knee(s) according to American College of Rheumatology (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.

Primary outcomes:
measure: Self-reported pain and function (WOMAC)
Secondary outcomes:
measure: General health status (SF-36)
measure: Psychological well being (DASS)
measure: Patient global assessment (100mm visual analogue scale [VAS])
measure: Physical performance: 50 feet walk time, stair time
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
Study officials:
affiliation: The George Institute, University of Sydney
name: Marlene H Fransen, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: St George Hospital, University of NSW
name: John Edmonds, MB, BS
role: STUDY_CHAIR
References:
citation: 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.