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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201210000416118 Date registered: 2012/09/17
TRIAL DESCRIPTION
Public title Minimalist versus conventional running shoes: Effects on injury prevalence and muscle function in experienced distance runners
Official scientific title Minimalist versus conventional running shoes: Effects on injury prevalence and muscle function in experienced distance runners
Brief summary describing the background
and objectives of the trial
Minimalist running shoes are gaining popularity among runners. However, there is a lack of evidence regarding the effects of different types of running shoes on the neuromusculoskeletal system, and this may have implications for injury prevalence. This study will investigate the differences between conventional and minimalist running shoes on injury prevalence and muscle function (calf endurance, muscle flexibility, muscle power, foot posture index, satisfaction and hallux ROM).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2012-09-03
Actual trial start date 2012-09-17
Anticipated date of last follow up 2012-12-07
Actual date of last follow up 2012-12-07
Anticipated target sample size (number of participants) 30   
Actual target sample size (number of participants) 30   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID
258/2012 Health Sciences Faculty, Human Research Ethics Committee

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Minimalist running shoes Throughout the entire 12 weeks of the study Throughout the entire 12 weeks of the study Particpants will run in the minimalist running shoes during the 12 weeks of the period 15
Control group Conventional running shoes Throughout the entire 12 weeks of the study Throughout the 12 weeks of the study Participants will run in the conventional shoes during the 12 weeks of the study period 15 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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. 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. 18 Years 50 Years Male

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2012/09/05 Health Sciences Faculty, Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital, Old main building, Observatory Cape Town 7925 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Muscle flexibility (hamstring) 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Calf endurance 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Muscle flexibility (Gastrocnemius) 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Lower limb muscle power 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Foot posture index 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Participants' satisfaction with the type of running shoes 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Hallux range of motion 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Injury prevalence 0 weeks 4 weeks 8 weeks 12 weeks
Secondary Outcome Total distance run per week 0 weeks 1 wk 2 wk 3 wk 4 wk 5 wk 6 wk 7 wk 8 wk 9 wk 10 wk 11 wk 12 wk
Secondary Outcome Total time run per week 0 week 1 wk 2 wk 3 wk 4 wk 5 wk 6 wk 7 wk 8 wk 9 wk 10 wk 11 wk 12 wk
Secondary Outcome RPE scores 0 week 1 wk 2 wk 3 wk 4 wk 5 week 6 wk 7 wk 8 wk 9 wk 10 wk 11 wk 12 wk
Secondary Outcome BPI scores 0 week 1 week 2 wk 3 wk 4 wk 5 wk 6 wk 7 wk 8 wk 9 wk 10 wk 11 wk 12 wk
Secondary Outcome Location and severity of injury 0 weeks 1 week 2 wk 3 wk 4 wk 5 wk 6 wk 7 wk 8 wk 9 wk 10 wk 11 wk 12 wk

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Running clubs in Port Elizabeth Around Port Elizabeth Port Elizabeth 6001 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Inov-8/ REBEL park office Johannesburg South Africa
Inov-8/ REBEL park office Orlik drive, corner of George Allen and Mount Joy Johannesburg 1609 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Inov-8/REBEL park office Orlik drive, corner of George Allen and Mount Joy Johannesburg 1609 South Africa Company

COLLABORATORS
Name Street address City Postal code Country
Dr Theresa Burgess Groote Schuur Hospital, Department of Health and Rehabilitation Sciences, F45 old main building, Observatory Cape Town 7925 South Africa
Ms Candice Hendricks Groote Schuur Hospital, Department of Health and Rehabilitation Sciences, F45 old main building, Observatory Cape Town 7925 South Africa
Professor Martin Schwellnus Sports Science Institute of South Africa, Newlands Cape Town 7925 South Africa
Ms Charlene Marshall Windermere Road, Humewood Port Elizabeth 6001 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Ms Charlene Marshall charleneclairemarshall@ gmail.com 0731776330
Street address City Postal code Country Position / Affiliation
Windermere Road, Humewood Port Elizabeth 6001 South Africa Masters student in Physiotherapy
Role Name Email Phone Fax
Public Enquiries Dr Theresa Burgess theresa.burgess@uct.ac.za 0214066171
Street address City Postal code Country Position / Affiliation
Groote Schuur Hospital, Department of health and rehabilitation sciences, F45 old main building, Observatory Cape Town 7925 South Africa Main supervisor
Role Name Email Phone Fax
Scientific Enquiries Dr Theresa Burgess theresa.burgess@uct.ac.za 0214066171
Street address City Postal code Country Position / Affiliation
Groote Schuur Hospital, Department of health and rehabilitation sciences, F45 old main building, Observatory Cape Town 7925 South Africa Main supervisor