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临床试验/NCT05881148
NCT05881148已完成不适用

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

Hôpital Léon Bérard2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
30m-sprint Time

研究概览

简要总结

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 IAAF/WA 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.

详细描述

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 (i.e 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 can't 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 ").

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Each participant is self-blinded, but also blinded to other participants ' alternative order

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sprinting athletes affiliated to the French Athletic Federation among the Var Athletics Comity
  • Sprint Performance > 750pts IAAF/WA (50 to 400m)

排除标准

  • Ongoing Injury

结局指标

主要结局

30m-sprint Time

时间窗: in a 3 hour session a day

16 x30m-sprint per subject

次要结局

未报告次要终点

研究者

发起方
Hôpital Léon Bérard
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin BERNUZ, MD

Dr Bernuz Benjamin; PMR; MD-MSc

Hôpital Léon Bérard

研究点 (2)

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