Efficacy of a Physiotherapy Intervention by Training the Inspiratory Muscles With the Powerbreathe® Device to Improve Inspiratory Strength and Muscle Recovery in Semi-professional Soccer Players. A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change from baseline inspiratory force after treatment and at month
研究概览
简要总结
Soccer requires the activation of aerobic and anaerobic metabolism. The increase of the ventilatory demand stimulates the increase of the neural impulse to the respiratory muscles, increasing the mechanical power of the inspiratory muscles.
The main objective of the study is to assess the effectiveness in the improvement of the strength of the inspiratory muscles and the muscular recovery with the Powerbreathe® device in semi-professional soccer players.
Randomized double-blind clinical study with follow-up period. 36 semi-professional soccer players from the province of Soria will be randomly distributed to the study groups: experimental (inspiratory muscle training with 50% resistance) and control (10% resistance training). The dependent variables will be: aerobic and anaerobic sports performance (Cooper's 12-Minute Run Test and Repeated Sprint Ability), blood lactate concentration (Lactate Scout®), and lung function using the ergo-respiratory parameters (maximum inspiratory pressure, expiratory pressure maximum, forced vital capacity and forced expiratory volume in 1 second). The sample distribution will be calculated using the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
It is intended to observe improvement in inspiratory strength levels, decrease in blood lactate concentration and an increase in aerobic and anaerobic sports performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Football players
- •With an age range of 18 to 35 years
- •Which currently compete in the category of Spanish third division nationally.
排除标准
- •Subjects who have some type of injury that prevents them from practicing sports at the time of study
- •With medical diagnosis of respiratory pathology
- •That are not able to overcome the respiratory resistance of the device
- •Have not signed the informed consent document.
结局指标
主要结局
Change from baseline inspiratory force after treatment and at month
时间窗: Screening visit, within the first seven days after treatment and after one month follow-up visit
An assessment will be made by spirometry of the maximum inspiratory pressure. A portable spirometer will be used (Mir Smart One model, MIR INC, New Berlin, WI, USA). The evaluation will be carried out according to the protocol indicated by the American Thoracic Society. The athlete will be placed in standing position holding the mouthpiece with his hand and with the wise sealed around it. After a full expiration you will proceed to a quick and deep inspiration. The unit of measure of this measuring instrument is cmH2O. A higher score indicates a greater inspiratory force.
次要结局
- Change from baseline anaerobic performance after treatment and at month(Screening visit, within the first seven days after treatment and after one month follow-up visit)
- Change from baseline muscle recovery after treatment and at month(Screening visit, within the first seven days after treatment and after one month follow-up visit)
- Change from baseline aerobic performance after treatment and at month(Screening visit, within the first seven days after treatment and after one month follow-up visit)