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Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)

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ClinicalTrials.gov Identifier: NCT00123994
Recruitment Status : Unknown
Verified July 2005 by St George Hospital, Australia.
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2005
Last Update Posted : November 3, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Osteoarthritis, Hip Osteoarthritis, Knee Behavioral: Tai Chi classes Behavioral: Hydrotherapy classes

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Study Start Date : February 2004
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Self-reported pain and function (WOMAC)

Secondary Outcome Measures :
  1. General health status (SF-36)
  2. Psychological well being (DASS)
  3. Patient global assessment (100mm visual analogue scale [VAS])
  4. Physical performance: 50 feet walk time, stair time

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123994

Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Australian Government Department of Health and Ageing
St George Division of General Practice, NSW, Australia.
The University of New South Wales
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00123994     History of Changes
Other Study ID Numbers: NAMCIG56
RFP 95/0203
First Posted: July 26, 2005    Key Record Dates
Last Update Posted: November 3, 2005
Last Verified: July 2005

Keywords provided by St George Hospital, Australia:
Joint pain

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases