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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 April 2013
Main ID:  PACTR201210000416118
Date of registration: 17/09/2012
Primary sponsor:
Public title: Minimalist versus conventional running shoes: Effects on injury prevalence and muscle function in experienced distance runners
Scientific title: Minimalist versus conventional running shoes: Effects on injury prevalence and muscle function in experienced distance runners
Date of first enrolment: 2012-09-17
Target sample size: 30
Recruitment status: Closed to recruitment: follow up continuing
URL:  HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201210000416118
Study type:  interventional
Study design:  Single group: all participants receive same intervention throughout study,
Randomised,
Stratified allocation using age and years of running experience,
Allocation was determined by the holder of the sequence who is sitiated off site,
 
Countries of recruitment
South Africa
Contacts
Name: Theresa  Burgess
Address:  Groote Schuur Hospital, Department of health and rehabilitation sciences, F45 old main building, Observatory 7925 Cape Town South Africa
Telephone: 0214066171
Email: theresa.burgess@uct.ac.za
Affiliation:  Main supervisor
Name: Theresa  Burgess
Address:  Groote Schuur Hospital, Department of health and rehabilitation sciences, F45 old main building, Observatory 7925 Cape Town South Africa
Telephone: 0214066171
Email: theresa.burgess@uct.ac.za
Affiliation:  Main supervisor
Key inclusion & exclusion criteria
Inclusion criteria: The study will include healthy males between 18 and 50 years of age.
They must currently run in conventional running shoes.
The participants will be required to be running between 40 and 60 kilometres (km) per week in the six-month period prior to the study.
The runners also need to have a minimum running experience of two years.

Exclusion criteria: Participants who report any relevant medical or surgical history, including a history of lower limb or lumbar spine injury or pathology within the last three months will be excluded from the study.
Participants already running in minimalist running shoes will also be excluded from the study.
Other exclusion criteria include lower limb alignment abnormalities, including increased Q-angles and leg length discrepancies. Participants who take part in any races over 21.1 km in distance will also be excluded from the study.
If a participant sustains an injury during the 12 week study period, they will not be required to perform further testing.


Age minimum: 18 Year
Age maximum: 50 Year
Gender: Male
Health Condition(s) or Problem(s) studied

Injury prevalence, Muscle function
Intervention(s)
Primary Outcome(s)
Calf endurance
Foot posture index
Hallux range of motion
Injury prevalence
Lower limb muscle power
Muscle flexibility (Gastrocnemius)
Muscle flexibility (hamstring)
Participants' satisfaction with the type of running shoes
Secondary Outcome(s)
BPI scores
Location and severity of injury
RPE scores
Total distance run per week
Total time run per week
Secondary ID(s)
258/2012
Source(s) of Monetary Support
Inov-8/ REBEL park office
Secondary Sponsor(s)
Inov-8/REBEL park office
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