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临床试验/NCT05145192
NCT05145192已完成不适用

Validity and Reliability of the K5 Wearable Metabolic System During High-Intensity Treadmill Testing in Healthy, Young Adults

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Oxygen consumption (VO2), mL/min

研究概览

简要总结

To determine the validity of the K5 metabolic system breath-by-breath analysis setting during a high intensity treadmill running protocol compared to the criterion ParvoMedics TrueOne® 2400 automated metabolic gas analysis system.

To determine the test-retest reliability of the K5 metabolic system breath-by-breath analyzer during a high intensity treadmill protocol (Bruce Protocol).

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
20 Years 至 29 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •20-29 years of age

排除标准

  • •Pregnancy
  • •Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation
  • •Contraindications to Symptom-limited Maximal Exercise Testing
  • •Metabolic disease
  • •Pacemakers/Implantable devices
  • •Supplemental Oxygen use
  • •Diagnosis of severe arterial hypertension
  • •Uncontrolled asthma

研究组 & 干预措施

COSMED K5 CPET

Experimental

Participants in this arm will complete the CPET using the COSMED K5 wearable metabolic system at first visit and the ParvoMedics TrueOne® 2400 automated metabolic gas analysis system at second visit.

干预措施: COSMED K5 CPET (Cardiopulmonary Exercise Test) (Device)

COSMED K5 CPET

Experimental

Participants in this arm will complete the CPET using the COSMED K5 wearable metabolic system at first visit and the ParvoMedics TrueOne® 2400 automated metabolic gas analysis system at second visit.

干预措施: ParvoMedics CPET (Device)

ParvoMedics CPET

Active Comparator

Participants in this arm will complete the CPET using the ParvoMedics TrueOne® 2400 automated metabolic gas analysis system at first visit and the COSMED K5 wearable metabolic system at second visit.

干预措施: COSMED K5 CPET (Cardiopulmonary Exercise Test) (Device)

ParvoMedics CPET

Active Comparator

Participants in this arm will complete the CPET using the ParvoMedics TrueOne® 2400 automated metabolic gas analysis system at first visit and the COSMED K5 wearable metabolic system at second visit.

干预措施: ParvoMedics CPET (Device)

结局指标

主要结局

Oxygen consumption (VO2), mL/min

时间窗: At third assessment, during week three.

Using metabolic cart, VO2 will be recorded.

Carbon dioxide production (VCO2), mL/min

时间窗: At third assessment, during week three.

Using metabolic cart, VCO2 will be recorded.

Carbon dioxide production (VCO2), mL/min

时间窗: At first assessment, during week one.

Using metabolic cart, VCO2 will be recorded.

Oxygen consumption (VO2), mL/min

时间窗: At first assessment, during week one.

Using metabolic cart, VO2 will be recorded.

Oxygen consumption (VO2), mL/min

时间窗: At second assessment, during week two.

Using metabolic cart, VO2 will be recorded.

Carbon dioxide production (VCO2), mL/min

时间窗: At second assessment, during week two.

Using metabolic cart, VCO2 will be recorded.

次要结局

  • Breathing Reserve, %(At third assessment, during week three.)
  • Respiratory Exchange Ratio (RER)(At third assessment, during week three.)
  • Fractional expired carbon dioxide (FECO2)(At third assessment, during week three .)
  • Minute Ventilation, L/min(At third assessment, during week three.)
  • Fractional expired oxygen (FEO2)(At third assessment, during week three.)
  • Tidal Volume, L(At third assessment, during week three.)
  • Respiratory Frequency, /min(At third assessment, during week three.)
  • Respiratory Exchange Ratio (RER)(At first assessment, during week one.)
  • Respiratory Exchange Ratio (RER)(At second assessment, during week two.)
  • Minute Ventilation, L/min(At first assessment, during week one.)
  • Minute Ventilation, L/min(At second assessment, during week two.)
  • Breathing Reserve, %(At first assessment, during week one.)
  • Breathing Reserve, %(At second assessment, during week two.)
  • Tidal Volume, L(At first assessment, during week one.)
  • Tidal Volume, L(At second assessment, during week two.)
  • Respiratory Frequency, /min(At first assessment, during week one.)
  • Respiratory Frequency, /min(At second assessment, during week two.)
  • Fractional expired oxygen (FEO2)(At first assessment, during week one.)
  • Fractional expired oxygen (FEO2)(At second assessment, during week two.)
  • Fractional expired carbon dioxide (FECO2)(At first assessment, during week one.)
  • Fractional expired carbon dioxide (FECO2)(At second assessment during week two.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Driver

Research Center Director - The STAR at Frisco

Baylor Research Institute

研究点 (1)

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