Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000548033
Ethics application status
Approved
Date submitted
7/07/2010
Date registered
8/07/2010
Date last updated
8/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Molecular and biochemical characteristics of skeletal muscle in patients with osteoarthritis
Scientific title
Molecular and biochemical characteristics of skeletal muscle in patients with osteoarthritis
Secondary ID [1] 252179 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis (OA) 257669 0
Condition category
Condition code
Musculoskeletal 257849 257849 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross-sectional study. We will compare muscle function and metabolism of elderly people with osteoarthritis with muscle from elderly people without OA and young volunteers.
In addition, we will correlate muscle function and metabolism measures with gait, strength and quality of life measures in people with OA.
Each patient is observed twice and each session will take 60 minutes. In addition, people with OA will come to the laboratory for one session of 3 hours to assess their gait.
Intervention code [1] 256739 0
Not applicable
Comparator / control treatment
This study will compare 3 groups: elderly people with severe OA, aged and body mass index (BMI) matched asymptomatic individuals and young volunteers.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258713 0
Muscle metabolism:
- inflammatory cytokine gene and protein expressions
- genes and proteins that involved in muscular protein synthesis and degradation.
- proteins and genes involved in regulating ion transport and excitability including sudium potassium pumps.
The outcomes will be assessed from analyses of muscle samples (western blots and messenger ribonucleic acid (mRNA) expression).
Timepoint [1] 258713 0
Cross sectional
Secondary outcome [1] 264738 0
Correlation between the Primary measures and gait and strength measures. Gait measures will be assessed using Vicon. Strength will be assessed using strain gauge (load cell).
Timepoint [1] 264738 0
Cross sectional

Eligibility
Key inclusion criteria
Patients with severe OA (knee replacement surgery) (age greater than or equal to 50).
Asymptomatic individuals: aged and BMI matched to the OA group.
Asymptomatic young-individuals (age 18-35). These volunteers will be matched for sex with the elderly people with knee OA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- people aged 36-49 years,
- in the asymptomatic individuals we will exclude those with clinical diagnosis of osteoarthritis or rheumatoid arthritis or a history of knee trauma.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257224 0
Charities/Societies/Foundations
Name [1] 257224 0
LEW Carty
Country [1] 257224 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University,
PO Box 14428
Melbourne, VIC 8001
Country
Australia
Secondary sponsor category [1] 256473 0
University
Name [1] 256473 0
La Trobe University
Address [1] 256473 0
Musculoskeletal Research Centre
Faculty of Health Sciences, La Trobe University
Bundoora, Victoria 3086, Australia
Country [1] 256473 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259246 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 259246 0
Victoria University Human Research Ethics Committee
Office for Industry and Research
Victoria University
PO Box 14428
Melbourne VIC 8001
Ethics committee country [1] 259246 0
Australia
Date submitted for ethics approval [1] 259246 0
Approval date [1] 259246 0
25/08/2008
Ethics approval number [1] 259246 0
HRETH 08/149

Summary
Brief summary
Knee osteoarthritis (OA), is a painful, chronic and progressive condition. Intense efforts are being directed towards finding the causes and effective treatments. But OA has more widespread consequences, including the loss of muscle mass and function in the affected legs. The loss of muscle is potentially both a consequence of OA, due to reduced limb use, but may also be a direct consequence of inflammatory mechanism set in motion by the knee inflammation. The aims of the current project are: (a) to compare genes which are involved in muscular protein synthesis and degradation in people with knee osteoarthritis (OA) and in asymptomatic older and young people. (b) To investigate the interaction between muscle breakdown and regeneration and impaired gait pattern in people with knee OA. This research is important, as preserving muscle mass is central to regaining effective limb use and reduce disease symptoms.

Hypothesis
(a) Older individuals with OA will have increased localisation of inflammatory immune cells within the skeletal muscle and increased activation of protein degradation pathways within the muscle cells, compared to asymptomatic older and young people.
(b) In people with OA, there is an interaction between muscle protein and gene levels that will be associated with impaired gait measures.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31352 0
Address 31352 0
Country 31352 0
Phone 31352 0
Fax 31352 0
Email 31352 0
Contact person for public queries
Name 14599 0
Dr Itamar Levinger
Address 14599 0
School of Sport and Exercise Science
Victoria University,
PO Box 14428
Melbourne, VIC 8001
Country 14599 0
Australia
Phone 14599 0
61 3 9919 5343
Fax 14599 0
Email 14599 0
[email protected]
Contact person for scientific queries
Name 5527 0
Dr Itamar Levinger
Address 5527 0
School of Sport and Exercise Science
Victoria University,
PO Box 14428
Melbourne, VIC 8001
Country 5527 0
Australia
Phone 5527 0
61 3 9919 5343
Fax 5527 0
Email 5527 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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