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

November 2, 2005 updated by: St George Hospital, Australia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

59 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Self-reported pain and function (WOMAC)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George Hospital, Australia

Collaborators

The University of New South Wales
Australian Government Department of Health and Ageing
St George Division of General Practice, NSW, Australia.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

July 22, 2005

First Submitted That Met QC Criteria

July 22, 2005

First Posted (Estimate)

July 26, 2005

Study Record Updates

Last Update Posted (Estimate)

November 3, 2005

Last Update Submitted That Met QC Criteria

November 2, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAMCIG56
  • RFP 95/0203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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