Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000524594
Ethics application status
Approved
Date submitted
14/12/2006
Date registered
20/12/2006
Date last updated
20/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Knee malalignment and thigh muscles strengthening in individuals with medial knee arthritis
Scientific title
The effects of knee malalignment and quadriceps strengthening on increasing the adduction moment in individuals with medial knee osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 1498 0
Condition category
Condition code
Musculoskeletal 1596 1596 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:

1. Quadriceps exercise over fulcrum using ankle weight
2. Straight leg raise exercise using ankle weight
3. Long arc knee extension exercise in sitting using ankle weight
4. Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
5. Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.

Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.

Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.
Intervention code [1] 1506 0
Rehabilitation
Comparator / control treatment
Participants in the control group did not receive any intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 2202 0
Adduction moment
Timepoint [1] 2202 0
At 0 and 13 weeks
Secondary outcome [1] 3834 0
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Timepoint [1] 3834 0
0 and 13 weeks
Secondary outcome [2] 3835 0
Numerical rating scales for pain
Timepoint [2] 3835 0
0 and 13 weeks
Secondary outcome [3] 3836 0
Quadriceps and hamstrings strength
Timepoint [3] 3836 0
0 and 13 weeks
Secondary outcome [4] 3837 0
Self-selected walking speed
Timepoint [4] 3837 0
0 and 13 weeks
Secondary outcome [5] 3838 0
Dynamic balance using step test
Timepoint [5] 3838 0
0 and 13 weeks
Secondary outcome [6] 3839 0
Physical function using stair climb test
Timepoint [6] 3839 0
0 and 13 weeks

Eligibility
Key inclusion criteria
Tibiofemoral joint osteoarthritis in at least one knee fulfilling the American College of Rheumatology classification criteria (Altman et al 1986):1. Pain in the knee; 2. Over 50 years of age and;3. Osteophytes on knee x-ray.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Knee surgery within the previous 6 months;2. History of lower limb joint replacements;3. Systemic arthritic conditions such as rheumatic or psoriatic arthritis;4. Inability to walk without the use of walking aids.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Assessor blinded
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
107
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1740 0
Charities/Societies/Foundations
Name [1] 1740 0
Physiotherapy Research Foundation (Thermoskin Tagged Research Grant from United Pacific Industries)
Country [1] 1740 0
Primary sponsor type
Individual
Name
Professor Kim Bennell
Address
Country
Secondary sponsor category [1] 1535 0
Individual
Name [1] 1535 0
Boon Lim
Address [1] 1535 0
Country [1] 1535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3218 0
The University of Melbourne-University of Melbourne human research ethics committee
Ethics committee address [1] 3218 0
Ethics committee country [1] 3218 0
Australia
Date submitted for ethics approval [1] 3218 0
Approval date [1] 3218 0
15/12/2004
Ethics approval number [1] 3218 0
040850

Summary
Brief summary
To investigate the effects of thigh muscles strengthening on knee joint loading and to examine if the effects are different in people with and without knee malalignment (bow legs)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27440 0
Address 27440 0
Country 27440 0
Phone 27440 0
Fax 27440 0
Email 27440 0
Contact person for public queries
Name 10695 0
Boon Lim
Address 10695 0
Centre for Health, Exercise and Sports Medicine
202 Berkeley Street
Carlton VIC 3010
Country 10695 0
Australia
Phone 10695 0
+61 3 83440486
Fax 10695 0
Email 10695 0
[email protected]
Contact person for scientific queries
Name 1623 0
Professor Kim Bennell
Address 1623 0
Centre for Health, Exercise and Sports Medicine
202 Berkeley Street
Carlton VIC 3010
Country 1623 0
Australia
Phone 1623 0
+61 3 83444135
Fax 1623 0
Email 1623 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.