Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881148
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2023-05-19
Brief Title:
Carbon Sprinting Spiked-Shoes Trial
Sponsor:
Hôpital Léon Bérard
Organization:
Hôpital Léon Bérard
Study Overview
Official Title:
Carbon Super Spikes Performances on Sprint Acceleration Just Use it A Multiple N-of-1 Trial A Multiple N-of-1 Trial in Healthy Athletes
Status:
COMPLETED
Status Verified Date:
2023-10
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:
CS3T
Brief Summary:
Objectives
To determine intra and inter-subject sprinting performance modifications with trademarked Carbon-made spiked-Shoes CS compared to usual carbon-free ones Standard spiked-Shoes-SS
Methods
Design Multiple N-of-1 trial Alternating Treatments Design with block randomisation and double blind procedure For each participants sixteen repetitions of 30m-sprint are applied either with CS or SS in random order for each repetition during a 3h session a day Blind procedures are reached by applying a dark sleeve cover on each shoes and by separating raters from investigators
Patients Regional to National healthy sprinting athletes 750 IAAFWA points affiliated to the French Athletics Federation among the South Regional Athletic League Comité du Var-FFA are recruited as volunteers with their own CS from the same brand for homogeneity and generalisation concerns and SS
Main criteria Time on a 30-meters sprint with Force-Velocity Profiling FVP procedure using Stalker Sport radar
Secondary outcome measures F0 V0 Vmax Pmax DRP and other standard FVP parameters also measured with MySprint software morphometric and cinematic data mean price difference between the two models
Statistical analyses A block randomisation model will be applied to check for the randoms size variance analysis with a mixt linear model will be applied for group and confounding factors analysis Student-T test and NAP will be applied for intra-individuals analysis
To determine intra and inter-subject sprinting performance modifications with trademarked Carbon-made spiked-Shoes CS compared to usual carbon-free ones Standard spiked-Shoes-SS
Methods
Design Multiple N-of-1 trial Alternating Treatments Design with block randomisation and double blind procedure For each participants sixteen repetitions of 30m-sprint are applied either with CS or SS in random order for each repetition during a 3h session a day Blind procedures are reached by applying a dark sleeve cover on each shoes and by separating raters from investigators
Patients Regional to National healthy sprinting athletes 750 IAAFWA points affiliated to the French Athletics Federation among the South Regional Athletic League Comité du Var-FFA are recruited as volunteers with their own CS from the same brand for homogeneity and generalisation concerns and SS
Main criteria Time on a 30-meters sprint with Force-Velocity Profiling FVP procedure using Stalker Sport radar
Secondary outcome measures F0 V0 Vmax Pmax DRP and other standard FVP parameters also measured with MySprint software morphometric and cinematic data mean price difference between the two models
Statistical analyses A block randomisation model will be applied to check for the randoms size variance analysis with a mixt linear model will be applied for group and confounding factors analysis Student-T test and NAP will be applied for intra-individuals analysis
Detailed Description:
Setting The medical commission of the Var Athletics Committee VAC composed by medicine doctors physiotherapists universitary sport-scientists and FFA coaches was in charge of the project at Toulon conurbation and Draguignan France
Design N-of-1 Trials is the usual term for randomized double-blind SCEDs This one has been designed as an Alternating Treatment Design ATD one of the four SCEDs types 25
Due to the strict on-off intervention effect no potential interference was expected between phases and a best treatment final phase seems not necessary in the absence of carry-over or interaction effects After discussion with coaches and athletes the main constraint was to respect a single day standard short-sprint training session ie commonly 5 to 15 repetitions up to 500m total volume Respecting these conditions and the preference of athletes ATD method seemed the more appropriate allowing the most cycle comparisons in the same time span
Procedure For each participants sixteen repetitions 2 sets of 8 of maximal 30m-sprint are applied on the same track either with carbon super-spikes CS or standard spikes SS in random order for each repetition during a 3h total session a day Repetitions are preceded by a full warm-up and followed by a cool-down phase Rest time between sets and repetitions is standardised 20 and 8-10 minutes
Block starting cant be choosen in order to limit bias reaction time adjustment and to allow radar records at the pelvis height 1-m high as recommended so that a split-stance starting position was adopted without any starter as soon as ready
A path is created between a polling booth zone and the start- and finish lines In this blinding zone athletes are sitted on a wheelchair blindfolded and putted on with their shoes which are already covered by dark socks allowing spikes free athletes visual blinding Footwear management by the investigators avoid athletes to have tactile information athletessomesthesic blinding Shoes can not be seen by raters assessors visual blinding or other athletes in that zone They are then driven to the start-line with the wheelchair in order to limit gait sensation due to important differences in foams air-pods between CS and SS athletes proprioceptive blinding This last point was added after athletes contribution to the method
At the start-line they are asked for their belief between CS or SS so that a doubt rate can be assessed to check for the blind paradigm Then the blindfold is removed and the subject stand-up in the starting position
After the finish-line a 20m deceleration zone is ended by a wheelchair where athletes are blindfolded again shoes tooken off and bringed back to the polling booth zone as athletes enter the rest zone
The wind is controlled with the official WAFFA method and anemometer The shoes weight is assessed and standardised when needed with the addition of 20g ballasts glued at the heel so that weight difference is decreased 50g
Data are collected and examined by two assessors blinded from the randomisation list
Subjects Healthy 15 years-old athletes presenting with a 750 IAAFWorld Athletics points level in sprinting 60-400m and affiliated to the VAC are screened with the SIFFA software Système dInformation-FFA Fourty-six athletes are eligible and are contacted by email as their coaches for information letter Due to homogeneity and generalisation concerns they have to have their own or lended Nike Zoom Maxfly or Victory style Twenty-five respond positively and N21 are availables for one of the half-day-proposed sessions and are included
Design N-of-1 Trials is the usual term for randomized double-blind SCEDs This one has been designed as an Alternating Treatment Design ATD one of the four SCEDs types 25
Due to the strict on-off intervention effect no potential interference was expected between phases and a best treatment final phase seems not necessary in the absence of carry-over or interaction effects After discussion with coaches and athletes the main constraint was to respect a single day standard short-sprint training session ie commonly 5 to 15 repetitions up to 500m total volume Respecting these conditions and the preference of athletes ATD method seemed the more appropriate allowing the most cycle comparisons in the same time span
Procedure For each participants sixteen repetitions 2 sets of 8 of maximal 30m-sprint are applied on the same track either with carbon super-spikes CS or standard spikes SS in random order for each repetition during a 3h total session a day Repetitions are preceded by a full warm-up and followed by a cool-down phase Rest time between sets and repetitions is standardised 20 and 8-10 minutes
Block starting cant be choosen in order to limit bias reaction time adjustment and to allow radar records at the pelvis height 1-m high as recommended so that a split-stance starting position was adopted without any starter as soon as ready
A path is created between a polling booth zone and the start- and finish lines In this blinding zone athletes are sitted on a wheelchair blindfolded and putted on with their shoes which are already covered by dark socks allowing spikes free athletes visual blinding Footwear management by the investigators avoid athletes to have tactile information athletessomesthesic blinding Shoes can not be seen by raters assessors visual blinding or other athletes in that zone They are then driven to the start-line with the wheelchair in order to limit gait sensation due to important differences in foams air-pods between CS and SS athletes proprioceptive blinding This last point was added after athletes contribution to the method
At the start-line they are asked for their belief between CS or SS so that a doubt rate can be assessed to check for the blind paradigm Then the blindfold is removed and the subject stand-up in the starting position
After the finish-line a 20m deceleration zone is ended by a wheelchair where athletes are blindfolded again shoes tooken off and bringed back to the polling booth zone as athletes enter the rest zone
The wind is controlled with the official WAFFA method and anemometer The shoes weight is assessed and standardised when needed with the addition of 20g ballasts glued at the heel so that weight difference is decreased 50g
Data are collected and examined by two assessors blinded from the randomisation list
Subjects Healthy 15 years-old athletes presenting with a 750 IAAFWorld Athletics points level in sprinting 60-400m and affiliated to the VAC are screened with the SIFFA software Système dInformation-FFA Fourty-six athletes are eligible and are contacted by email as their coaches for information letter Due to homogeneity and generalisation concerns they have to have their own or lended Nike Zoom Maxfly or Victory style Twenty-five respond positively and N21 are availables for one of the half-day-proposed sessions and are included
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