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
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
-
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.