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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00123994
• Other study ID #: NAMCIG56
• Secondary ID: RFP 95/0203
• Status: Active, not recruiting
• Phase: N/A
• First received: July 22, 2005
• Last updated: November 2, 2005
• Start date: February 2004
• Est. completion date: October 2005

Study information

• Verified date: July 2005
• Source: St George Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 59 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Behavioral:
• Tai Chi classes

• Hydrotherapy classes

Locations

Country	Name	City	State
Australia	St George Hospital	Kogarah	New South Wales

Sponsors (4)

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

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain and function (WOMAC)
Secondary	General health status (SF-36)
Secondary	Psychological well being (DASS)
Secondary	Patient global assessment (100mm visual analogue scale [VAS])
Secondary	Physical performance: 50 feet walk time, stair time