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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by St George Hospital, Australia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Department of Health and Aging, Commonwealth Government, Australia.
St George Division of General Practice, NSW, Australia.
The University of New South Wales
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00123994
First received: July 22, 2005
Last updated: November 2, 2005
Last verified: July 2005
History of Changes
  Purpose

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 Intervention
Osteoarthritis, Hip
Osteoarthritis, Knee
 Behavioral: Tai Chi classes
Behavioral: Hydrotherapy classes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St George Hospital, Australia:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: October 2005
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

Ages Eligible for Study:   59 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123994

Locations
Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Department of Health and Aging, Commonwealth Government, Australia.
St George Division of General Practice, NSW, Australia.
The University of New South Wales
Investigators
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

No publications provided by St George Hospital, Australia

Additional 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
Study First Received: July 22, 2005
Last Updated: November 2, 2005
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by St George Hospital, Australia:
TaiChi
Hydrotherapy
Exercise
Joint pain
Disability

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

ClinicalTrials.gov processed this record on May 16, 2013