NCT00123994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 3, 2005

Status Verified

July 1, 2005

First QC Date

July 22, 2005

Last Update Submit

November 2, 2005

Conditions

Keywords

TaiChiHydrotherapyExerciseJoint painDisability

Outcome Measures

Primary Outcomes (1)

  • Self-reported pain and function (WOMAC)

Secondary Outcomes (4)

  • 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

Interventions

Eligibility Criteria

Age59 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic osteoarthritis of the hip(s) or knee(s) according to American College of Rheumatology (ACR) clinical and radiographic (hip) criteria.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, KneeMotor ActivityArthralgia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marlene H Fransen, PhD MPH

    The George Institute, University of Sydney

    PRINCIPAL INVESTIGATOR
  • John Edmonds, MB, BS

    St George Hospital, University of NSW

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2005

First Posted

July 26, 2005

Study Start

February 1, 2004

Study Completion

October 1, 2005

Last Updated

November 3, 2005

Record last verified: 2005-07

Locations