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

NCT ID: NCT00123994

Last Updated: 2005-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Hip Osteoarthritis, Knee

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

TaiChi Hydrotherapy Exercise Joint pain Disability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tai Chi classes

Intervention Type BEHAVIORAL

Hydrotherapy classes

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

59 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Australian Government Department of Health and Ageing

OTHER_GOV

Sponsor Role collaborator

St George Division of General Practice, NSW, Australia.

UNKNOWN

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

St George Hospital, Australia

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlene H Fransen, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

The George Institute, University of Sydney

John Edmonds, MB, BS

Role: STUDY_CHAIR

St George Hospital, University of NSW

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St George Hospital

Kogarah, New South Wales, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 17443749 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RFP 95/0203

Identifier Type: -

Identifier Source: secondary_id

NAMCIG56

Identifier Type: -

Identifier Source: org_study_id