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临床试验/NCT05984186
NCT05984186已完成不适用

Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline

Vapotherm, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Blood Lactate Change

研究概览

简要总结

The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test. The study will include four study segments, corresponding to four different therapy settings.

详细描述

HVT has been found to be a useful clinical tool for treatment of Type 1 and Type 2 respiratory failure (including hypercapnic respiratory failure), acute decompensated heart failure, and COVID respiratory complications. The overall objective of this prospective, pilot study is to evaluate whether HVT might enhance the decline of blood lactate concentrations following a high intensity exercise bout, in healthy volunteers. The hypothesis is that HVT, regardless of the oxygen concentration (i.e., FiO2), will reduce the work of breathing and increase the lactate clearance rate during exercise and recovery intervals. This pilot study could ignite further research providing HVT applications to high performing athletics and patients in an acute care setting requiring physical rehabilitation.

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults18-30 years old, in a general state of good health, of either sex
  • No known contraindication to performing a maximal exercise test, i.e., Wingate-type Anaerobic exercise test
  • Participants must consider themselves able to perform "regular moderate" or "regular strenuous" exercise.
  • ° "Regular moderate" exercise includes less than 30 minutes every day or 30 minutes every other day, of some form of deliberate exercise, that does not include walking.
  • ° "Regular strenuous" exercise is 30+ minutes per day, of some form of deliberate exercise, that does not include walking.

排除标准

  • Not considered a 'high-performance athlete'
  • Known active cardiovascular, metabolic, liver, or renal disease
  • Orthopedic limitations to exercise
  • Pregnancy
  • Use of beta-blockers or beta-agonist asthma medications
  • Exercise induced asthma
  • Any other health-related issue that would involve the participant's fitness capability
  • Inability to complete all of the study procedures

结局指标

主要结局

Blood Lactate Change

时间窗: At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60).

The change in blood lactate starting from the exercise test throughout the recovery period

次要结局

  • Respiratory Rate Change(Prior to the Wingate test (TR) and after at 1min (T1), 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.)
  • Heart Rate Change(Prior to the Wingate test (TR) and after 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.)
  • SpO2 Change(Prior to the Wingate test (TR) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.)
  • Systolic Blood Pressure Change(Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.)
  • Diastolic Blood Pressure Change(Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.)
  • Perceived Level of Exertion Change(Immediately after the Wingate test (T0) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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