Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
28/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tom Cochrane

ORCID ID

Contact details

Sport Health & Exercise
University of Staffordshire
Leek Road
Stafford
ST4 2DF
United Kingdom
+44 (0)1782 295 855
t.cochrane@staffs.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/32/99

Study information

Scientific title

Acronym

ROAR

Study hypothesis

Hydrotherapy is believed to be an effective treatment for osteoarthritis (OA). Many physiotherapy centres have specialise hydrotherapy pools but, most remain under utilised because they are not cost-effective to run. Thus a valued service is unrealised on cost grounds. In recent years, aqua- aerobics has become a popular mode of exercise and is used by many people who suffer from "joint" problems. Despite this growth in popularity, neither the efficacy nor the cost-effectiveness of community-based water therapy in the rehabilitation of OA has been evaluated in a well-designed trial. The potential value of this form of treatment to the NHS, therefore, remains unknown.

A randomised controlled trial is proposed, to determine:
1. The efficacy of water exercise in the treatment of OA of the lower limb
2. The cost-effectiveness of such an approach
3. The longer term implications of such intervention

Stages 2. and 3. will be contingent on the outcome of stage 1.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal diseases: Arthritis (osteo)

Intervention

1. Hydrotherapy
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain score on the Western Ontario and McMaster Universities OA index (WOMAC).

Secondary outcome measures

Additional outcome measures were included to evaluate effects on quality of life, cost-effectiveness and physical function measurements.

Overall trial start date

01/04/2000

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients suffering lower limb osteoarthritis

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

106

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/04/2000

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sport Health & Exercise
Stafford
ST4 2DF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16095546

Publication citations

  1. HTA monograph

    Cochrane T, Davey RC, Matthes Edwards SM, Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis., Health Technol Assess, 2005, 9, 31, iii-iv, ix-xi, 1-114.

Additional files

Editorial Notes