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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
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.
Secondary ID [1] 282564 0
Nil
Universal Trial Number (UTN)
U1111-1143-4829
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
running injuries 289233 0
running shoe comfort 289234 0
Condition category
Condition code
Musculoskeletal 289566 289566 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 287227 0
Prevention
Comparator / control treatment
No treatment: Participants will continue to use their own running shoes
Control group
Active

Outcomes
Primary outcome [1] 289660 0
Running injuries survey specifically written for this study that includes details on footwear worn, type and distance of training, practitioner and self diagnosed injuries.
Timepoint [1] 289660 0
baseline and 1,3 and 6 months after intervention commencement
Secondary outcome [1] 302968 0
Running shoe comfort survey specifically written for this study with questions concerning shoe comfort measured using a 100mm Visual Analogue Scale (VAS)
Timepoint [1] 302968 0
baseline and 1, 3 and 6 months after intervention commencement

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be via a software randomisation function
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2011
Actual
15/08/2011
Date of last participant enrolment
Anticipated
1/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287339 0
University
Name [1] 287339 0
The University of Newcastle, Australia
Country [1] 287339 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country
Australia
Secondary sponsor category [1] 286089 0
None
Name [1] 286089 0
Address [1] 286089 0
Country [1] 286089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289317 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 289317 0
Ethics committee country [1] 289317 0
Australia
Date submitted for ethics approval [1] 289317 0
Approval date [1] 289317 0
Ethics approval number [1] 289317 0
H-2011-0176

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

Contacts
Principal investigator
Name 40294 0
Dr Vivienne Chuter
Address 40294 0
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 40294 0
Australia
Phone 40294 0
+ 61 2 43 494 424
Fax 40294 0
Email 40294 0
Vivienne.Chuter@newcastle.edu.au
Contact person for public queries
Name 40295 0
Vivienne Chuter
Address 40295 0
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 40295 0
Australia
Phone 40295 0
+ 61 2 43 494 424
Fax 40295 0
Email 40295 0
Vivienne.Chuter@newcastle.edu.au
Contact person for scientific queries
Name 40296 0
Vivienne Chuter
Address 40296 0
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 40296 0
Australia
Phone 40296 0
+ 61 2 43 494 424
Fax 40296 0
Email 40296 0
Vivienne.Chuter@newcastle.edu.au

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.