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临床试验/NCT07285252
NCT07285252Enrolling By Invitation不适用

ENDURE- Evaluating Non-Invasive Haptics During Extreme Exercise

SuperPatch Limited LLC2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年1月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
75
试验地点
2
主要终点
Change in VO2 Max

研究概览

简要总结

This study aims to compare determinants of endurance performance between participants wearing an active patch with haptic vibrotactile trigger technology (VTT) versus a placebo patch without VTT among recreational to competitive runners over a 4-week training period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and over, that participate in recreational to competitive distance running (>2 structured runs per week), that were able to complete maximal treadmill exercise safely and were able to attend three laboratory visits were invited to participate.

排除标准

  • Adults with a contraindications to high-intensity treadmill exercise, cardiovascular, metabolic, or musculoskeletal conditions limiting participation, reported use of performance-enhancing drugs, pregnancy, known allergy to adhesives, or current use of neuromodulatory or haptic devices

研究组 & 干预措施

TREATMENT

Active Comparator

Victory Patch

干预措施: Victory Patch with Haptic Vibrotactile Trigger Technology (Device)

CONTROL

Placebo Comparator

Sham Comparator

干预措施: Sham patch (Device)

结局指标

主要结局

Change in VO2 Max

时间窗: 2-weeks and 4-weeks after baseline assessment

Change in VO₂max (mL/kg-¹/min-¹, calculated as a 30-second rolling average)

次要结局

  • Change in Lactate-threshold running speed(2-weeks and 4-weeks after baseline assessment)

研究者

发起方
SuperPatch Limited LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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