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: pactr.samrc.ac.za
Trial no.: PACTR201210000416118 Date of Approval: 17/09/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Injury prevalence, Muscle function,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/09/2012
Actual trial start date 17/09/2012
Anticipated date of last follow up 07/12/2012
Actual Last follow-up date 07/12/2012
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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
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 Outcome Assessors
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 50 Year(s) 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 05/09/2012 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 Calf endurance 0 weeks 4 weeks 8 weeks 12 weeks
Primary Outcome Muscle flexibility (hamstring) 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 Commercial Sector/Industry
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 Street address
Principal Investigator Charlene Marshall charleneclairemarshall@gmail.com 0731776330 Windermere Road, Humewood
City Postal code Country Position/Affiliation
Port Elizabeth 6001 South Africa Masters student in Physiotherapy
Role Name Email Phone Street address
Public Enquiries Theresa Burgess theresa.burgess@uct.ac.za 0214066171 Groote Schuur Hospital, Department of health and rehabilitation sciences, F45 old main building, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Main supervisor
Role Name Email Phone Street address
Scientific Enquiries Theresa Burgess theresa.burgess@uct.ac.za 0214066171 Groote Schuur Hospital, Department of health and rehabilitation sciences, F45 old main building, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Main supervisor
REPORTING
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Result URL Hyperlinks
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