Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000642785
Ethics application status
Approved
Date submitted
31/05/2013
Date registered
7/06/2013
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of footwear on running performance and injury risk
Scientific title
In distance runners, do lightweight running shoes, compared to standard running shoes, improve running performance and reduce risk of injury?
Secondary ID [1] 282383 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Running-related injury 288964 0
Condition category
Condition code
Injuries and Accidents 289297 289297 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A lightweight running shoe with minimal cushioning and reduced heel lift will be the intervention in this study. The total duration of the study intervention is 26 weeks. This will consist of an initial 20 week transition period where partipants allocated to the intervention group will gradually switch from running in their previous shoe to the lightweight shoe with minimal cushioning and a reduced heel lift. In the first week following allocation this will consist of using the lightweight running shoe with minimal cushioning and reduced heel lift for 5% of the total running performed for that week. This duration will increase by a further 5% each week so that in week 20 participants will be performing 100% of their running in the lightweight running shoe with minimal cushioning and a reduced heel lift. Weeks 21-26 will involve all running in the lightweight running shoe with minimal cushioning and a reduced heel lift.

Adherence to this intervention protocol will be monitored in a study diary that participants will be required to fill out daily.
Intervention code [1] 287013 0
Prevention
Comparator / control treatment
A standard cushioned running shoe with a built-up heel will be the control treatment. The cushioned shoe will be gradually introduced over the first 20 weeks in the same manner described for the intervention shoe. And weeks 21-26 will involve all running in the cushioned running shoe with a built-up heel.
Control group
Active

Outcomes
Primary outcome [1] 289406 0
5 km time trial performance
Timepoint [1] 289406 0
6 weeks following randomisation to treatment group.
Secondary outcome [1] 302413 0
Injury incidence: a participant will be considered injured for the entire duration of each week that they answer yes to the question “in the previous seven days have you experienced an injury that has required the use of medication, a visit to a health professional or a reduction in running speed, distance or duration?” This will be followed by questions exploring the cause and medical diagnosis. Assessment will be undertaken by participants in a study diary and will occur on a weekly basis.
Timepoint [1] 302413 0
26 weeks following randomisation to treatment group.
Secondary outcome [2] 303025 0
Running economy measured during sub-maximal treadmill running and determined from the expired gases collected by a Hans-Rudolph two-way non-return breathing valve that will be connected to a ParvoMedics gas analysis system.
Timepoint [2] 303025 0
6 weeks following randomisation to treatment group.
Secondary outcome [3] 303026 0
Running biomechanics assessed during overground running trials. Running kinematics will be measured using a 12 camera VICON MX F20 system. Running kinematics will be measured using four force platforms aligned in series.
Timepoint [3] 303026 0
6 weeks following randomisation to treatment group.
Secondary outcome [4] 303027 0
Isometric, concentric and eccentric calf muscle strength measured using a Biodex isokinetic dynamometer.
Timepoint [4] 303027 0
26 weeks following randomisation to treatment group.
Secondary outcome [5] 303028 0
Bone mineral density at the proximal tibia, calcaneus and metatarsals measured using a Lunar Prodigy dual-energy x-ray absorptiometry scanner.
Timepoint [5] 303028 0
26 weeks following randomisation to treatment group.

Eligibility
Key inclusion criteria
Run a minimum of 15 km per week.
5 km time trial performance less than 23 minutes.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous history of running in a lightweight running shoe with minimal cushioning and reduced heel lift.
Run with a midfoot or forefoot footfall.
Previous history of orthotic use with running shoes in the previous 3 months.
Previous history of muculoskeletal injury that affected running within the previous 3 months.
Previous history of invasive surgery that affected running within the previous 12 months.

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)
Participants will be recruited via public advertisement at local running clubs, fitness centres and running events. Participants who meet the eligibility criteria will be required to provide written informed consent prior to enrolment.

Allocation to treatment will be performed by an independent investigator who is not involved in data collection and is located in a seperate area of the building.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation via minimisation using 5 km time trial time recorded at a familiarisation visit as the minimisation variable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Sample size calculation was based on detecting a Cohen's d effect size of 0.3 for the primary outcome of 5km running performance using an analysis of covariance. This calculation was performed using the formula described by Borm et al. (2007) and an estimation of the correlation between 5km performance measured at baseline and at follow-up that was obtained from South Australian 5km road race results in 2011 and 2012 (Athletics SA 2012). The Cohen's d effect size of 0.3 was based on previous research that has investigated differences in running economy between lightweight and standard running shoes (Warne et al. 2013; Perl et al. 2012; Squadrone et al. 2009; Divert et al. 2008; Hamill et al. 1988)

Borm GF, Fransen J, Lemmens WAJG. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007;60:1234-8.
Athletics South Australia 2012, viewed 1st October 2012, http://www.athleticssa.com.au/wp/wordpress/?page_id=408
Warne JP, Warrington GD. Four-week habituation to simulated barefoot running improves running economy when compared with shod running. Scand J Med Sci Sports. 2013; doi:10.1111/sms.12032
Perl DP, Daoud AI, Lieberman DE. Effects of footwear and strike type on running economy. Med Sci Sports Exerc. 2012;44:1335-1343.
Squadrone R, Gallozzi C. Biomechanical and physiological comparison of barefoot and two shod conditions in experienced barefoot runners. J Sports Med Phys Fitness. 2009;49:6-13.
Divert C, Mornieux G, Freychat P, et al. Barefoot-shod running differences: shoe or mass effect? Int J Sports Med. 2008;29:512-8.
Hamill J, Freedson PS, Boda W, et al. Effects of shoe type on cardiorespiratory responses and rearfoot motion during treadmill running. Med Sci Sports Exerc. 1988;20:515-521.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2013
Actual
10/07/2013
Date of last participant enrolment
Anticipated
Actual
9/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287155 0
Self funded/Unfunded
Name [1] 287155 0
Country [1] 287155 0
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 285920 0
None
Name [1] 285920 0
Address [1] 285920 0
Country [1] 285920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289152 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 289152 0
General Purpose Building, Mawson Lakes Campus Mawson Lakes Boulevard Mawson Lakes, SA 5095
Ethics committee country [1] 289152 0
Australia
Date submitted for ethics approval [1] 289152 0
Approval date [1] 289152 0
11/04/2013
Ethics approval number [1] 289152 0
31065

Summary
Brief summary
There is currently no scientific evidence concerning the direct effect of running shoes on running performance and prevention of injury. It has been suggested that excessive cushioning in running shoes may have had the unintended effect of weakening the foot and altering the way that people run. Lightweight running shoes with minimal cushioning and reduced heel lift have been shown to increase muscle strength and cause potentially beneficial changes to the way that we run. Lightweight running shoes may be of benefit to runners wanting to improve running performance and prevent injury. The aim of this project is to investigate the long term effects of running shoes on running performance and prevention of injury.
Trial website
Trial related presentations / publications
Fuller JT, Thewlis D, Tsiros MD, Brown NAT, Buckley JD. The long-term effect of minimalist shoes on running performance and injury: design of a randomised controlled trial. BMJ Open 2015;5:e008307.

Fuller JT, Archer J, Buckley JD, Tsiros MD, Thewlis D. The reliability of dual-energy X-ray absorptiometry measurements of bone mineral density in the metatarsals. Skeletal Radiol. 2015 [Epub ahead of print] DOI: 10.1007/s00256-015-2227-0.

Fuller JT, Thewlis D, Tsiros MD, Brown N & Buckley JD. Training in a minimalist shoe increases ankle joint loading and 5km running performance. 20th European College of Sports Science Congress, Malmo, Sweden, June 2015.

Fuller JT, Thewlis D, Tsiros MD, Brown N & Buckley JD. Training in a minimalist shoe improves running performance in trained distance runners. ASICS Sports Medicine Australia Conference, Gold Coast, Queensland, October 2015.
Public notes

Contacts
Principal investigator
Name 39494 0
Mr Joel Thomas Fuller
Address 39494 0
University of South Australia
City East Campus
Frome Rd Adelaide SA 5001
Country 39494 0
Australia
Phone 39494 0
+61 (08) 8302 1315
Fax 39494 0
Email 39494 0
[email protected]
Contact person for public queries
Name 39495 0
Mr Joel Thomas Fuller
Address 39495 0
University of South Australia
City East Campus
Frome Rd Adelaide SA 5001
Country 39495 0
Australia
Phone 39495 0
+61 (08) 8302 1315
Fax 39495 0
Email 39495 0
[email protected]
Contact person for scientific queries
Name 39496 0
Mr Joel Thomas Fuller
Address 39496 0
University of South Australia
City East Campus
Frome Rd Adelaide SA 5001
Country 39496 0
Australia
Phone 39496 0
+61 (08) 8302 1315
Fax 39496 0
Email 39496 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
SourceTitleYear of PublicationDOI
EmbaseThe long-term effect of minimalist shoes on running performance and injury: Design of a randomised controlled trial.2015https://dx.doi.org/10.1136/bmjopen-2015-008307
EmbaseSix-week transition to minimalist shoes improves running economy and time-trial performance.2017https://dx.doi.org/10.1016/j.jsams.2017.04.013
N.B. These documents automatically identified may not have been verified by the study sponsor.