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临床试验/NCT01608529
NCT01608529已完成1 期

Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise

University of Cadiz1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
27
试验地点
1
主要终点
Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists

研究概览

简要总结

It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with the aim of increase nasal airflow resistance, therefore the objective was to examine the effects of FeelBreathe with lung ventilation and gas exchange during exercise.

详细描述

Background: Different devices are currently used to train inspiratory muscles, thus showing an increase in the physical performance. It is a control trial to investigate the effects of a new restriction and filtering device ventilatory nasal flow (FeelBreathe).

Methods: A total of 27 trained male caucasian subjects (age: 32.5 ± 7.23 years) were recruited from different sports clubs. Measurement of maximum static inspiratory pressure were taken before exercise testing and an incremental test in cycle ergometer to volitional fatigue for the determination of gas exchange data. Each subject performed three identical submaximal exercises at 50% of ventilatory thresholds under different breathing conditions: 1) oronasal breathing 2) nasal breathing and 3) nasal breathing with Feel Breathe, Restriction and Filtering Device Ventilatory Nasal Flow.

Discussion: Researchers try to find if the new device called FeelBreathe causes changes in the lung ventilation and gas exchange during exercise. If the results show altered breathing pattern and cardiometabolic variables, FeelBreathe could be used to training respiratory muscles.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Age: 25-35 years.
  • •trained male caucasian cyclists
  • •Non-smokers
  • •Each subject completed an approved informed consent form and detailed health questionnaire before testing.

排除标准

  • •Presence of diseases during the test period. In particular, they had no current symptoms of nasal disease, snoring, asthma or allergic rhinitis.
  • •Unwillingness to complete the study requirements.

研究组 & 干预措施

Cyclist group

Experimental

干预措施: Feel Breathe, restriction device ventilatory nasal (Device)

结局指标

主要结局

Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists

时间窗: Subjects were assessed during 8 weeks

VE (l/min), Vtin (ml/kg), BF (bf/min), VCO2 (ml/min), VE/VO2 (ml), VE/VCO2 (ml), RER (VCO2/VO2), PETO2 (mmHg), PETCO2 (mmHg), tin (s/insp), tex (s/expir), Vtin (ml/min), Vtex (ml/min), SPO2 (%) and VO2 (ml/kg/min) were assessed throughout the exercise on a cycle ergometer (ERGO-Line GmbH + CoKG, mod. Jaeger ER-900. Germany) using three different conditions of breathing: oronasal, nasal and nasal breathing with FeelBreathe, with 10-sec sampling intervals using a open circuit spirometry (CPX Cardinal Health, 234 GmbH, Leibnizstrasse 7, D-97204 Hoechberg, Germany).

次要结局

  • Maximum oxygen uptake(Subjects were assessed during 8 weeks)
  • Maximum static inspiratory pressure (PImax)(Subjects were assessed during 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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