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Trial registered on ANZCTR
Registration number
ACTRN12613000612718
Ethics application status
Approved
Date submitted
23/05/2013
Date registered
28/05/2013
Date last updated
28/05/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of running shoe design on comfort and injury rates in recreational runners
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Scientific title
A randomised controlled trial to compare comfort and injury rates in recreational runners with normal foot type wearing motion control running shoes versus barefoot running shoes versus their own running shoes.
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Secondary ID [1]
282564
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Nil
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Universal Trial Number (UTN)
U1111-1143-4829
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
running injuries
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running shoe comfort
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Condition category
Condition code
Musculoskeletal
289566
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm1: Participants will receive a pair of dual density running shoes. The ASICS (Registered Trademark) GEL-1100 (Trademark) series shoe provided is a motion control shoe that provides cushioning and stability.
Arm2: Participants will receive a pair of barefoot running shoes. The Vibram FiveFingers (Registered Trademark) Sprint model provided has a polyamide fabric upper and performance rubber sole.
Participants being issued with a new pair of footwear will be given a two week adjustment period to adapt to the new footwear prior to beginning the study. Participants will be asked to wear the shoes for some or all of their weekly running sessions if they are comfortable doing so.
Study duration is 6 months and participants will complete surveys at baseline, 1 month, 3 months and 6 months.
Adherence will be monitored via the surveys. Questions include how many times per week the footwear was used, percentage of training completed in the footwear, and details of training (type, distance, surface)
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Intervention code [1]
287227
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Prevention
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Comparator / control treatment
No treatment: Participants will continue to use their own running shoes
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Control group
Active
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Outcomes
Primary outcome [1]
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Running injuries survey specifically written for this study that includes details on footwear worn, type and distance of training, practitioner and self diagnosed injuries.
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Assessment method [1]
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Timepoint [1]
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baseline and 1,3 and 6 months after intervention commencement
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Secondary outcome [1]
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Running shoe comfort survey specifically written for this study with questions concerning shoe comfort measured using a 100mm Visual Analogue Scale (VAS)
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Assessment method [1]
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Timepoint [1]
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baseline and 1, 3 and 6 months after intervention commencement
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Eligibility
Key inclusion criteria
i. Aged greater than or equal to 18 years;
ii. Recreational runners male or female with Foot Posture Index indicating a normal foot type (this category includes neutral to slightly flat);
iii. Must run regularly (2 sessions or more per week).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
i. The current use of foot orthoses;
ii. Any systemic disease affecting the musculoskeletal system;
iii. A history of major lower back and leg injury and/or surgery;
iv. A current acute injury that prevents running.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Regular recreational runners will be recruited by advertisement. Interested participants will be questioned regarding the inclusion and exclusion criteria during the initial telephone contact and then screened for foot type and other exclusion criteria at the initial appointment. Subjects will be randomised into one of two intervention groups or a control group . Randomisation will be stratified using history of running injury, gender and mileage to ensure similar groups from baseline. Allocation concealment will be used to prevent selection bias. Allocation will be by contacting the holder of the allocation schedule who was “off-site”.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be via a software randomisation function
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Fifty participants will be allocated to each group. We based the a priori sample size calculations on a minimal important difference of 10.2mm on a 100mm visual analogue scale for comfort (Mills et al., 2010). Assuming a standard deviation of 20 mm, a power of 0.80, and an a level of 0.05, we require 37 participants in each group. We increased the sample size by approximately 20%, in each group, to allow for loss to follow up. This has been rounded up to 50.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
15/08/2011
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Actual
15/08/2011
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Date of last participant enrolment
Anticipated
1/07/2013
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Newcastle, Australia
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Address [1]
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School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Newcastle
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Address
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
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The Chancellery
The University of Newcastle
Callaghan Campus
University Drive
Callaghan NSW 2308
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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Ethics approval number [1]
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H-2011-0176
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Summary
Brief summary
Information on comfort levels and incidence of running related pain or injury with each type of footwear will provide valuable evidence on the effect of footwear design, specifically motion control footwear versus barefoot running shoes on injury rates and runner comfort.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Vivienne Chuter
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Address
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The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
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Country
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Australia
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Phone
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+ 61 2 43 494 424
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Vivienne Chuter
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Address
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The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
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Country
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Australia
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Phone
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+ 61 2 43 494 424
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Vivienne Chuter
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Address
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The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
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Country
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Australia
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Phone
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+ 61 2 43 494 424
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Fax
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Email
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[email protected]
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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.
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