Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000623291
Ethics application status
Approved
Date submitted
23/07/2009
Date registered
27/07/2009
Date last updated
5/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined exercise and psychological treatment for knee osteoarthritis pain
Scientific title
Exercise and cognitive behavioural training for knee osteoarthritis pain
Secondary ID [1] 283697 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 237346 0
Condition category
Condition code
Musculoskeletal 239667 239667 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
muscle strengthening, walking program, cognitive behavioural training

Participants will complete a home program of 6 hip and thigh muscle strengthening exercises at home 3 times per week (3 sets of 10). They will also walk at least 15 minutes continuously 2 times peer week. The intervention will last 10 weeks. Participants will receive 10 consultations (one per week) with a physiotherapist who will ensure proper performance of exercises and safe progression of the program (increased resistance for strength, increased time for walking). At each consultation they will also receive 45 minutes of cognitive behavioural training administered by a trained physiotherapist.
Intervention code [1] 237007 0
Treatment: Other
Comparator / control treatment
muscle strengthening, walking program, non-directive counselling

Participants will complete a home program of 6 hip and thigh muscle strengthening exercises at home 3 times per week (3 sets of 10). They will also walk at least 15 minutes continuously 2 times peer week. The intervention will last 10 weeks. Participants will receive 10 consultations (one per week) with a physiotherapist who will ensure proper performance of exercises and safe progression of the program (increased resistance for strength, increased time for walking). At each consultation they will also receive 45 minutes of non-directive counselling administered by a trained physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 238441 0
knee pain - visual analogue scale; Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Timepoint [1] 238441 0
immediately following the 10-week intervention
Secondary outcome [1] 244945 0
physical function - Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Timepoint [1] 244945 0
immediately following the 10-week intervention
Secondary outcome [2] 244946 0
pain coping - Coping Strategies Questionnaire
Timepoint [2] 244946 0
immediately following the 10-week intervention

Eligibility
Key inclusion criteria
diagnosis of knee osteoarthritis; pain on most days of previous month
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous lower limb joint replacement; knee surgery, injection, or physiotherapy for knee pain in past 6 months; currently completing a formalised exercise program for knee pain; unable to walk without a gait aid; medical condition precluding safe exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
subjects will be recruited by an individual not involved in the assessments. Randomisation will occur prior to the trial and group allocation will occur for each participant after baseline testing using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
4/08/2010
Date of last participant enrolment
Anticipated
Actual
15/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237390 0
University
Name [1] 237390 0
University of Melbourne
Country [1] 237390 0
Australia
Primary sponsor type
Individual
Name
Prof Kim Bennell
Address
Centre for Health, Exercise and Sports Medicine
University of Melbourne
Melbourne, VIC
3010
Country
Australia
Secondary sponsor category [1] 236890 0
None
Name [1] 236890 0
Address [1] 236890 0
Country [1] 236890 0
Other collaborator category [1] 789 0
Individual
Name [1] 789 0
Dr. Michael Hunt
Address [1] 789 0
Centre for Health, Exercise and Sports Medicine
University of Melbourne
Melbourne, VIC
3010
Country [1] 789 0
Australia
Other collaborator category [2] 790 0
Individual
Name [2] 790 0
Prof Francis Keefe
Address [2] 790 0
Rm 240
932 Morreene Rd
Durham, NC
27705
Country [2] 790 0
United States of America
Other collaborator category [3] 791 0
Individual
Name [3] 791 0
Dr. Christina Bryant
Address [3] 791 0
Centre for Women's Mental Health
Royal Women's Hospital
132 Grattan Street
Carlton VIC
3053
Country [3] 791 0
Australia
Other collaborator category [4] 792 0
Individual
Name [4] 792 0
Assoc Prof Michael Nicholas
Address [4] 792 0
Pain Management Research Institute
Royal North Shore Hospital
St Leonards, NSW
2065
Country [4] 792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239522 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 239522 0
Ethics committee country [1] 239522 0
Australia
Date submitted for ethics approval [1] 239522 0
Approval date [1] 239522 0
04/06/2009
Ethics approval number [1] 239522 0
0931371

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29959 0
Dr Michael A. Hunt
Address 29959 0
University of British Columbia
Department of Physical Therapy
212-2177 Wesbrook Mall
Vancouver, BC Canada
V6T 1Z3
Country 29959 0
Canada
Phone 29959 0
+1 604 827 4721
Fax 29959 0
Email 29959 0
[email protected]
Contact person for public queries
Name 13206 0
Prof Kim Bennell
Address 13206 0
Centre for Health, Exercise and Sports Medicine
University of Melbourne
Melbourne, VIC
3010
Country 13206 0
Australia
Phone 13206 0
+61 3 8344 4135
Fax 13206 0
Email 13206 0
[email protected]
Contact person for scientific queries
Name 4134 0
Prof Kim Bennell
Address 4134 0
Centre for Health, Exercise and Sports Medicine
University of Melbourne
Melbourne, VIC
3010
Country 4134 0
Australia
Phone 4134 0
+61 3 8344 4135
Fax 4134 0
Email 4134 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.