Tai Chi or Hydrotherapy for People With Osteoarthritis of... | NCT00123994

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

NCT00123994

Sponsor

St George Hospital, Australia

Status

Unknown status

Last Update Posted

Nov 3, 2005Estimated

Enrollment

150

Phase

Not Applicable

Conditions

Osteoarthritis, Hip
Osteoarthritis, Knee

Interventions

Tai Chi classes
Hydrotherapy classes

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RFP 95/0203

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Oct 2005

First Submitted Date

Jul 22, 2005

First Submission Date that Met QC Criteria

Jul 22, 2005

First Posted Date

Jul 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2005

Last Update Posted Date

Nov 3, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

St George Hospital, AustraliaOTHER

Collaborators

Name	Class
Australian Government Department of Health and Ageing	OTHER_GOV
St George Division of General Practice, NSW, Australia.	UNKNOWN
The University of New South Wales	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported pain and function (WOMAC)

Secondary Outcomes

Measure	Description	Time Frame
General health status (SF-36)
Psychological well being (DASS)
Patient global assessment (100mm visual analogue scale [VAS])

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

59 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St George Hospital		Kogarah	New South Wales	2217	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17443749	Derived	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.

ID	Term
D015207	Osteoarthritis, Hip
D020370	Osteoarthritis, Knee
D009043	Motor Activity
D018771	Arthralgia

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Name	Type	Description	Arm Group Labels	Other Names
Tai Chi classes	Behavioral
Hydrotherapy classes	Behavioral