Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384872
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk
Sponsor:
Luxembourg Institute of Health
Organization:
Luxembourg Institute of Health
Study Overview
Official Title:
Effect of Foam Properties and Cushioning Position of Running Shoes on Injury Risk in Leisure-time Runners A Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RRI_Interv5
Brief Summary:
The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners Therefore the objectives are to investigate if
1 Extra soft cushioning materials can reduce injury risk compared to stiffer materials
2 Cushioning under the forepart of the shoe also influences injury risk independently of the cushioning at the rear part
3 Effects of cushioning material and position depend on the runners body mass
4 Perception of cushioning is related to both shoe cushioning and injury risk
5 Other weight-bearing locomotion activities ie number of steps per day besides running practice represents an independent risk factor for running-related injury
This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule Before the beginning of the study the participants will receive a pair of running shoes The three running shoe models will be exactly the same except for their foam properties at the rear and forepart of the shoe which will differ by 33 and 37 respectively The study shoes will be administered through random allocation The participants will be required to use these shoes for all running sessions and only for running activities
Participants will first fill out a baseline questionnaire During the intervention data on running practice will be downloaded from sports watches and their respective app via Strava Information on the use of the study shoes will be collected via a weekly questionnaire Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days A questionnaire on the perception of cushioning will be filled in by the participants at three time points after 5h of running 25h of running and at the end of follow-up
Primary hypothesis
- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners
Secondary hypothesis
Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners
Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties
Greater perceived cushioning is related to lower injury risk
1 Extra soft cushioning materials can reduce injury risk compared to stiffer materials
2 Cushioning under the forepart of the shoe also influences injury risk independently of the cushioning at the rear part
3 Effects of cushioning material and position depend on the runners body mass
4 Perception of cushioning is related to both shoe cushioning and injury risk
5 Other weight-bearing locomotion activities ie number of steps per day besides running practice represents an independent risk factor for running-related injury
This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule Before the beginning of the study the participants will receive a pair of running shoes The three running shoe models will be exactly the same except for their foam properties at the rear and forepart of the shoe which will differ by 33 and 37 respectively The study shoes will be administered through random allocation The participants will be required to use these shoes for all running sessions and only for running activities
Participants will first fill out a baseline questionnaire During the intervention data on running practice will be downloaded from sports watches and their respective app via Strava Information on the use of the study shoes will be collected via a weekly questionnaire Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days A questionnaire on the perception of cushioning will be filled in by the participants at three time points after 5h of running 25h of running and at the end of follow-up
Primary hypothesis
- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners
Secondary hypothesis
Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners
Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties
Greater perceived cushioning is related to lower injury risk
Detailed Description:
Study design
The design of this study is a randomized trial with an intervention period of six months Running footwear is provided by a renowned sport equipment manufacturer working in close collaboration with the Physical Activity Sport and Health PASH research group of the Luxembourg Institute of Health LIH PASH will be responsible for the management and execution of the study including random allocation of the study shoes recruitment and follow-up of the participants as well as data management and analysis The study design is based on the comparison of three running shoe versions which differ with respect to their foam properties and cushioning position ie rear and forepart of the shoe The cushioning properties at the rear and forepart of the three shoe versions will be within the range of values of models available on the market
Participants
Healthy leisure-time runners will be recruited through advertising in local newspapers and press releases within Luxembourg as well as via social media during the months of January 2025 to June 2025 The benefits for the participants are highlighted during the recruitment phase and are as follows 1 a free pair of running shoes and 2 a brief report on the main findings of the study However participants will be made aware that they will randomly receive one of the three study shoe versions to be worn during the intervention period for all their running activities
Volunteers willing to take part in the study will be invited to follow the process described hereafter
Volunteers have to register on the electronic system that will be specifically designed for the study and specify that they wish to enroll for the present study The inclusionexclusion criteria and study requirements will be reminded at this stage of the registration process
Volunteers will receive the full information of the study and informed consent containing the full name of the participants
Volunteers must declare that they freely consent to participate in the study by checking the appropriate boxes
Volunteers will have to fill in a baseline questionnaire
Volunteers will have to set an appointment with the research team via the electronic system
Sample size
A sample size calculation for Cox regression was used to determine the number of participants needed for the primary hypothesis of the study With an alpha of 005 and a power of 80 an average injury rate of 30 see definition of the main outcome below an expected HR150 between groups 33 of participants randomized to each shoe group and an expected drop-out rate of 10 the total number of participants required is 1068
Intervention
The study shoes are prototypes derived from a model available on the market Kiprun KS 5002 and will be anonymized for the purpose of this trial The sole of the shoes will be customized for the purpose of the study The three running shoe models will be exactly the same except for their foam properties at the rear and forepart of the shoe which will differ by 33 and 37 respectively while remaining within the range of the shoes available on the market linear equivalent stiffness 40 to 60 and 50 to 80 Nmm at the rear and forepart of the shoe respectively We expect a difference in shoe weight lower than 30 g between the three versions for size 42 The difference in cushioning properties between shoe versions will be created by modifying the type of foam and the foaming process A set of shoes will be tested for cushioning properties by the manufacturer to provide accurate data on the technical specifications stiffness and dissipated energy
Model 1 Hard - about 60 and 80 Nmm at the rear and forepart of the shoe respectively
Model 2 Mixed - about 40 and 80 Nmm at the rear and forepart of the shoe respectively
Model 3 Soft - about 40 and 50 Nmm at the rear and forepart of the shoe respectively
The main hypothesis will be tested comparing the Mixed shoe version with the Hard shoe version while the secondary hypothesis will be tested comparing the Soft shoe version with both the Hard and Mixed shoe versions
Stratified randomization
Participants will be randomized at a 111 ratio to one of the three treatment arms A block randomization block size 12 will be performed Randomization will be stratified by sex as the latter influences body mass Based on data from previous studies it is expected that the study population will include about 40 of women Two pre-established randomization lists will be provided by a statistician LIH not involved in any other part of the study before the beginning of recruitment The participant identification number will be composed of 4 digits first digit corresponding to the participants sex 1female 2male followed by 3 digits corresponding to the randomization number
Data collection
Participants will have to fill in a baseline questionnaire that aims to collect information regarding demographics running experience training habits running competitions performed and injury history The recruitment phase of this project will last from January 2025 until June 2025 The follow-up period will start as soon as the participants have received their study shoes and will last for 6 months This means that the data collection phase will finish at the latest on the 31st of December 2025
Once a participant receives hisher pair of study shoes the intervention period begins for that participant During this intervention period the participants are required to use the study shoes for all their running activities to continue their usual or follow their planned training schedule and to fill out the weekly questionnaire on musculoskeletal complaints as well as on the use of the study shoes during the follow-up
Data on running practice will be downloaded from sports watches Garmin Polar and Suunto and their respective app via Strava Information on the use of the study shoes will be collected via a weekly questionnaire
Study participation will be terminated and the participant will be right-censored if heshe does not fill in the weekly injury form for 2 consecutive weeks does not reply or react to the automatic reminders 2 days after the initial invitation and could not be reached by phone by the research team 2 attempts Indeed a critical aspect for the validity of the study is to verify that the injury the main outcome is not the reason for dropping out Therefore we will contact these participants to confirm that they reported all injury before termination of the investigation
Participants will be asked to fill out a weekly questionnaire on any physical complaints experienced during the past 7 days the Oslo Sports Trauma Research Centre OSTRC Overuse Injury Questionnaire On top of the four basic questions information regarding the following is required data of first onset sports discipline anatomical location type of injury new recurrent subsequent event and estimated return date to full participation Individual e-mail reminders will be sent to the participants who do not fill out a weekly questionnaire Personal phone calls will be made if the participants do not react to the e-mail reminders and if the reported information in the injury form is found to be inconsistent
Study outcomes
Primary outcome
- First running-related injury occurring during the follow-up and defined as any running-related physical complaint in the lower limbs or lower back region that causes a restriction on or stoppage of running distance speed duration or training for at least seven days Practically this corresponds to injury forms where the participant answered option 3 or 4 in question 1 or option 1 2 or 3 in question 2 or question 3 of the OSTRC-O questionnaire
Secondary outcomes
First one-day time loss running-related injury Any running-related physical complaint in the lower limbs or lower back region that causes a restriction on or stoppage of running distance speed duration or training for at least one day More specifically this correspond to injury forms with option 3 or 4 in question 1 or option 1 2 or 3 in question 2 or question 3 of the OSTRC-O questionnaire without any minimal duration
First running-related musculoskeletal complaint Any physical complaint including pain ache joint instability stiffness or any other complaint resulting from participating in running activities including but irrespective of the need of medical attention seeking care from medical practitioner or time-loss inability to complete a running training session or participate in one or more days after the onset of injury More specifically injury forms with option 2 in question 1 of the OSTRC questionnaire will also be considered as outcome of interest in this case
First substantial running-related injury Injury forms where the participant answered options 3 or 4 in question 2 or question 3 of the OSTRC-O questionnaire
First overuse running-related injury Injury forms where the participant reported complaints with obvious acute mechanism such as ankle sprain will be excluded considered as competing risk
Statistical analysis
Descriptive data for the personal and training-related characteristics will be presented as count and percentage for dichotomous variables and as mean and standard deviation or as median and range for normally and non-normally distributed continuous variables respectively Average sport-related characteristics will be computed for each participant over their specific period of observation Shock absorption properties of the three shoes versions measured and provided by Decathlon will be compared using an Analysis of Variance
We will calculate the injury incidence as number of injuries per 1000 hours of running exposure for each outcome We will calculate the injury prevalence each week by dividing the number of participants that reported an injury by the number of respondents that week for each outcome We will then calculate the average weekly prevalence for each outcome and separately for the main anatomic locations
Competing-risks regression models will be used to investigate the effect of shoe version body mass and other possible risk factors by estimating the subdistribution hazard according to Fine and Gray Date of inclusion and date of injury or censoring will be basic data used to calculate the time at risk which is expressed in hours spent running and defined as the time-scale Participants will be right-censored if lost to follow-up or at the end of the intervention period Average sport-related characteristics will be computed for each participant over their specific period of observation The assumption of proportional hazards was evaluated using log-minus-log plots and Schoenfelds global test First unadjusted subdistribution hazards will be estimated for shoe versions body mass and other potential risk factors such as training-related characteristics Subsequently the variables with a P value 0200 as well as well-established potential confounders will be included in the adjusted model to determine whether shoe cushioning is associated with injury risk The recommendation for using at least ten injuries per predictor variable included in the regression analysis will be strictly followed Finally a stratified analysis will be performed to investigate if the effect of shoe cushioning on injury risk is modified by body mass Participants will be classified as light or heavy runners using the median value of body mass as cut-off independently in men and women SHRs and their 95 confidence intervals CI will be first determined for each stratum with the reference being the stratum with the lower risk Then SHRs and their 95 CI will be computed within strata to determine both the effect of shoe version within each body mass category and the effect of body mass within each shoe group
Sensitivity analysis First we will exclude the participants who sustained an injury over the first two weeks to investigate the potential impact of the transition to the study shoe on the findings Second depending on the compliance of the participants to the intervention ie use of the study shoes for each running session we will exclude the participants who did not use the study shoes for eg minimum 50 of their running sessions
The design of this study is a randomized trial with an intervention period of six months Running footwear is provided by a renowned sport equipment manufacturer working in close collaboration with the Physical Activity Sport and Health PASH research group of the Luxembourg Institute of Health LIH PASH will be responsible for the management and execution of the study including random allocation of the study shoes recruitment and follow-up of the participants as well as data management and analysis The study design is based on the comparison of three running shoe versions which differ with respect to their foam properties and cushioning position ie rear and forepart of the shoe The cushioning properties at the rear and forepart of the three shoe versions will be within the range of values of models available on the market
Participants
Healthy leisure-time runners will be recruited through advertising in local newspapers and press releases within Luxembourg as well as via social media during the months of January 2025 to June 2025 The benefits for the participants are highlighted during the recruitment phase and are as follows 1 a free pair of running shoes and 2 a brief report on the main findings of the study However participants will be made aware that they will randomly receive one of the three study shoe versions to be worn during the intervention period for all their running activities
Volunteers willing to take part in the study will be invited to follow the process described hereafter
Volunteers have to register on the electronic system that will be specifically designed for the study and specify that they wish to enroll for the present study The inclusionexclusion criteria and study requirements will be reminded at this stage of the registration process
Volunteers will receive the full information of the study and informed consent containing the full name of the participants
Volunteers must declare that they freely consent to participate in the study by checking the appropriate boxes
Volunteers will have to fill in a baseline questionnaire
Volunteers will have to set an appointment with the research team via the electronic system
Sample size
A sample size calculation for Cox regression was used to determine the number of participants needed for the primary hypothesis of the study With an alpha of 005 and a power of 80 an average injury rate of 30 see definition of the main outcome below an expected HR150 between groups 33 of participants randomized to each shoe group and an expected drop-out rate of 10 the total number of participants required is 1068
Intervention
The study shoes are prototypes derived from a model available on the market Kiprun KS 5002 and will be anonymized for the purpose of this trial The sole of the shoes will be customized for the purpose of the study The three running shoe models will be exactly the same except for their foam properties at the rear and forepart of the shoe which will differ by 33 and 37 respectively while remaining within the range of the shoes available on the market linear equivalent stiffness 40 to 60 and 50 to 80 Nmm at the rear and forepart of the shoe respectively We expect a difference in shoe weight lower than 30 g between the three versions for size 42 The difference in cushioning properties between shoe versions will be created by modifying the type of foam and the foaming process A set of shoes will be tested for cushioning properties by the manufacturer to provide accurate data on the technical specifications stiffness and dissipated energy
Model 1 Hard - about 60 and 80 Nmm at the rear and forepart of the shoe respectively
Model 2 Mixed - about 40 and 80 Nmm at the rear and forepart of the shoe respectively
Model 3 Soft - about 40 and 50 Nmm at the rear and forepart of the shoe respectively
The main hypothesis will be tested comparing the Mixed shoe version with the Hard shoe version while the secondary hypothesis will be tested comparing the Soft shoe version with both the Hard and Mixed shoe versions
Stratified randomization
Participants will be randomized at a 111 ratio to one of the three treatment arms A block randomization block size 12 will be performed Randomization will be stratified by sex as the latter influences body mass Based on data from previous studies it is expected that the study population will include about 40 of women Two pre-established randomization lists will be provided by a statistician LIH not involved in any other part of the study before the beginning of recruitment The participant identification number will be composed of 4 digits first digit corresponding to the participants sex 1female 2male followed by 3 digits corresponding to the randomization number
Data collection
Participants will have to fill in a baseline questionnaire that aims to collect information regarding demographics running experience training habits running competitions performed and injury history The recruitment phase of this project will last from January 2025 until June 2025 The follow-up period will start as soon as the participants have received their study shoes and will last for 6 months This means that the data collection phase will finish at the latest on the 31st of December 2025
Once a participant receives hisher pair of study shoes the intervention period begins for that participant During this intervention period the participants are required to use the study shoes for all their running activities to continue their usual or follow their planned training schedule and to fill out the weekly questionnaire on musculoskeletal complaints as well as on the use of the study shoes during the follow-up
Data on running practice will be downloaded from sports watches Garmin Polar and Suunto and their respective app via Strava Information on the use of the study shoes will be collected via a weekly questionnaire
Study participation will be terminated and the participant will be right-censored if heshe does not fill in the weekly injury form for 2 consecutive weeks does not reply or react to the automatic reminders 2 days after the initial invitation and could not be reached by phone by the research team 2 attempts Indeed a critical aspect for the validity of the study is to verify that the injury the main outcome is not the reason for dropping out Therefore we will contact these participants to confirm that they reported all injury before termination of the investigation
Participants will be asked to fill out a weekly questionnaire on any physical complaints experienced during the past 7 days the Oslo Sports Trauma Research Centre OSTRC Overuse Injury Questionnaire On top of the four basic questions information regarding the following is required data of first onset sports discipline anatomical location type of injury new recurrent subsequent event and estimated return date to full participation Individual e-mail reminders will be sent to the participants who do not fill out a weekly questionnaire Personal phone calls will be made if the participants do not react to the e-mail reminders and if the reported information in the injury form is found to be inconsistent
Study outcomes
Primary outcome
- First running-related injury occurring during the follow-up and defined as any running-related physical complaint in the lower limbs or lower back region that causes a restriction on or stoppage of running distance speed duration or training for at least seven days Practically this corresponds to injury forms where the participant answered option 3 or 4 in question 1 or option 1 2 or 3 in question 2 or question 3 of the OSTRC-O questionnaire
Secondary outcomes
First one-day time loss running-related injury Any running-related physical complaint in the lower limbs or lower back region that causes a restriction on or stoppage of running distance speed duration or training for at least one day More specifically this correspond to injury forms with option 3 or 4 in question 1 or option 1 2 or 3 in question 2 or question 3 of the OSTRC-O questionnaire without any minimal duration
First running-related musculoskeletal complaint Any physical complaint including pain ache joint instability stiffness or any other complaint resulting from participating in running activities including but irrespective of the need of medical attention seeking care from medical practitioner or time-loss inability to complete a running training session or participate in one or more days after the onset of injury More specifically injury forms with option 2 in question 1 of the OSTRC questionnaire will also be considered as outcome of interest in this case
First substantial running-related injury Injury forms where the participant answered options 3 or 4 in question 2 or question 3 of the OSTRC-O questionnaire
First overuse running-related injury Injury forms where the participant reported complaints with obvious acute mechanism such as ankle sprain will be excluded considered as competing risk
Statistical analysis
Descriptive data for the personal and training-related characteristics will be presented as count and percentage for dichotomous variables and as mean and standard deviation or as median and range for normally and non-normally distributed continuous variables respectively Average sport-related characteristics will be computed for each participant over their specific period of observation Shock absorption properties of the three shoes versions measured and provided by Decathlon will be compared using an Analysis of Variance
We will calculate the injury incidence as number of injuries per 1000 hours of running exposure for each outcome We will calculate the injury prevalence each week by dividing the number of participants that reported an injury by the number of respondents that week for each outcome We will then calculate the average weekly prevalence for each outcome and separately for the main anatomic locations
Competing-risks regression models will be used to investigate the effect of shoe version body mass and other possible risk factors by estimating the subdistribution hazard according to Fine and Gray Date of inclusion and date of injury or censoring will be basic data used to calculate the time at risk which is expressed in hours spent running and defined as the time-scale Participants will be right-censored if lost to follow-up or at the end of the intervention period Average sport-related characteristics will be computed for each participant over their specific period of observation The assumption of proportional hazards was evaluated using log-minus-log plots and Schoenfelds global test First unadjusted subdistribution hazards will be estimated for shoe versions body mass and other potential risk factors such as training-related characteristics Subsequently the variables with a P value 0200 as well as well-established potential confounders will be included in the adjusted model to determine whether shoe cushioning is associated with injury risk The recommendation for using at least ten injuries per predictor variable included in the regression analysis will be strictly followed Finally a stratified analysis will be performed to investigate if the effect of shoe cushioning on injury risk is modified by body mass Participants will be classified as light or heavy runners using the median value of body mass as cut-off independently in men and women SHRs and their 95 confidence intervals CI will be first determined for each stratum with the reference being the stratum with the lower risk Then SHRs and their 95 CI will be computed within strata to determine both the effect of shoe version within each body mass category and the effect of body mass within each shoe group
Sensitivity analysis First we will exclude the participants who sustained an injury over the first two weeks to investigate the potential impact of the transition to the study shoe on the findings Second depending on the compliance of the participants to the intervention ie use of the study shoes for each running session we will exclude the participants who did not use the study shoes for eg minimum 50 of their running sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None