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

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Tai Chi classes
Hydrotherapy classes
Sponsored by
St George Hospital, Australia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring TaiChi, Hydrotherapy, Exercise, Joint pain, Disability

Eligibility Criteria

59 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St George Hospital

Outcomes

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

Full Information

First Posted
July 22, 2005
Last Updated
November 2, 2005
Sponsor
St George Hospital, Australia
Collaborators
Australian Government Department of Health and Ageing, St George Division of General Practice, NSW, Australia., The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00123994
Brief Title
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

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis, Knee
Keywords
TaiChi, Hydrotherapy, Exercise, Joint pain, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Tai Chi classes
Intervention Type
Behavioral
Intervention Name(s)
Hydrotherapy classes
Primary Outcome Measure Information:
Title
Self-reported pain and function (WOMAC)
Secondary Outcome Measure Information:
Title
General health status (SF-36)
Title
Psychological well being (DASS)
Title
Patient global assessment (100mm visual analogue scale [VAS])
Title
Physical performance: 50 feet walk time, stair time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
59 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene H Fransen, PhD MPH
Organizational Affiliation
The George Institute, University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Edmonds, MB, BS
Organizational Affiliation
St George Hospital, University of NSW
Official's Role
Study Chair
Facility Information:
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
17443749
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.
Results Reference
derived

Learn more about this trial

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

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