Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000001493
Ethics application status
Approved
Date submitted
22/12/2006
Date registered
2/01/2007
Date last updated
11/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of hip muscle strengthening on knee load in knee osteoarthritis.
Scientific title
Effect of a 12-week program of hip abductor and adductor muscle strengthening on knee loading during walking in people with medial knee osteoarthritis.
Secondary ID [1] 287863 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis. 1504 0
Condition category
Condition code
Musculoskeletal 1602 1602 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People will be screened via telephone and undergo radiographic evaluation. Baseline testing will be performed at the University of Melbourne and the participant randomised into one of two groups: (i) hip strengthening; (ii) no strengthening control. The intervention will last for 12 weeks after which all participants will be reassessed by the same blinded assessor.

The exercise intervention will comprise 7 visits over 12 weeks to one of 7 physiotherapists located around Melbourne plus home exercises five times weekly. A comprehensive exercise manual will be produced. Programs comprise standardized progressive strengthening exercises but the physiotherapist will individually determine the repetitions (up to 10), sets (up to 2) and resistance depending on the person’s pain level and response. Resistance will be obtained from cuff weights to the ankle and theraband. These will also be provided for home use. The exercises will comprise sidelying hip abduction, hip abduction and adduction in standing with theraband, and isometric hip adduction squeezes.
Intervention code [1] 1525 0
Treatment: Other
Comparator / control treatment
The control group will not be given any intervention as part of the trial. Participants will be requested to continue their usual routines, activity levels and medication intake.
Control group
Active

Outcomes
Primary outcome [1] 2211 0
The external peak knee adduction moment measured during gait
Timepoint [1] 2211 0
Measured at baseline and 12 weeks.
Secondary outcome [1] 3855 0
Isometric hip adduction, hip abduction, hip flexion, quadricep and hamstring torque, Timed up and go (TUG) test, time taken to climb 8 steps, Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index, knee pain via a Visual Analogue Scale (VAS), patient perceived response to treatment and the Physical Activity Scale for the Elderly (PASE).
Timepoint [1] 3855 0
All measures at baseline and 12 weeks.

Eligibility
Key inclusion criteria
Eligibility will be confirmed by radiographic and clinical examination. Medial tibiofemoral joint osteoarthritis (OA) fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking >3 on an 11-point scale will be included. Other inclusion criteria will be: (i) varus knee malalignment on standing anteroposterior lower limb x-ray.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) knee surgery or intra-articular corticosteroid injection within 6 months; (ii) current or past (within 4 weeks) oral corticosteroid use; (iii) systemic arthritic conditions; (iv) history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy; (v) any other muscular, joint or neurological condition affecting lower limb function; (vi) back or hip pain within the past 3 years that caused the patient to seek treatment, take medication, miss work or interfere with function for at least one week; and (vii) any physiotherapy or lower limb strengthening exercises in the past 6 months.

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)
Sealed opaque envelopes kept in central location and opened at time of treatment by central administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, according to a computer-generated random number list. Variable block sizes will be used with blocks stratified according to gender and severity of knee OA.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor will be blind in this study.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
2/10/2007
Date of last participant enrolment
Anticipated
Actual
3/02/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1746 0
Government body
Name [1] 1746 0
National Health and Medical Research Council (NH&MRC) project grant
Country [1] 1746 0
Australia
Primary sponsor type
Individual
Name
Prof Kim Bennell
Address
University of Melbourne
Country
Australia
Secondary sponsor category [1] 1541 0
Individual
Name [1] 1541 0
Dr Rana Hinman
Address [1] 1541 0
University of Melbourne
Country [1] 1541 0
Australia
Secondary sponsor category [2] 1542 0
Individual
Name [2] 1542 0
Mr Tim Wrigley
Address [2] 1542 0
University of Melbourne
Country [2] 1542 0
Australia
Secondary sponsor category [3] 1543 0
Individual
Name [3] 1543 0
Dr David Hunter
Address [3] 1543 0
University of Boston
Country [3] 1543 0
United States of America
Secondary sponsor category [4] 2524 0
Individual
Name [4] 2524 0
Dr Michael Hunt
Address [4] 2524 0
University of Melbourne
Country [4] 2524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3225 0
University of Melbourne
Ethics committee address [1] 3225 0
Ethics committee country [1] 3225 0
Australia
Date submitted for ethics approval [1] 3225 0
12/01/2007
Approval date [1] 3225 0
27/09/2007
Ethics approval number [1] 3225 0
0709220

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

Contacts
Principal investigator
Name 27459 0
Prof Kim Bennell
Address 27459 0
Department of Physiotherapy
University of Melbourne
Country 27459 0
Australia
Phone 27459 0
+61 3 83444135
Fax 27459 0
Email 27459 0
[email protected]
Contact person for public queries
Name 10714 0
Prof Kim Bennell
Address 10714 0
School of Physiotherapy
University of Melbourne
Parkville VIC 3010
Country 10714 0
Australia
Phone 10714 0
+61 3 83448127
Fax 10714 0
+61 3 83443771
Email 10714 0
[email protected]
Contact person for scientific queries
Name 1642 0
Prof Kim Bennell
Address 1642 0
School of Physiotherapy
University of Melbourne
Parkville VIC 3010
Country 1642 0
Australia
Phone 1642 0
+61 3 83448127
Fax 1642 0
+61 3 83443771
Email 1642 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.