Overview

This trial is active, not recruiting.

Conditions osteoarthritis, hip, osteoarthritis, knee
Treatments tai chi classes, hydrotherapy classes
Sponsor St George Hospital, Australia
Collaborator Department of Health and Aging, Commonwealth Government, Australia.
Start date February 2004
End date October 2005
Trial size 150 participants
Trial identifier NCT00123994, NAMCIG56, RFP 95/0203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Self-reported pain and function (WOMAC)
time frame:

Secondary Outcomes

Measure
General health status (SF-36)
time frame:
Psychological well being (DASS)
time frame:
Patient global assessment (100mm visual analogue scale [VAS])
time frame:
Physical performance: 50 feet walk time, stair time
time frame:

Eligibility Criteria

Male or female participants from 59 years up to 85 years old.

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.

Additional Information

Official title Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Principal investigator Marlene H Fransen, PhD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by St George Hospital, Australia.