Clinical trial NCT04286074: Training of the Inspiratory Musculature in the Improvement of Inspiratory Strength and Muscle Recovery in Soccer Players
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breathing
Keywords: Breathing exercises
Soccer
Maximal respiratory pressures
Muscle Strength
Muscle fatigue
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2020-02-26
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Football players
* Male
* With an age range of 18 to 35 years
* Which currently compete in the category of Spanish third division nationally.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline inspiratory force after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
measure: Change from baseline muscle recovery after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline aerobic performance after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline anaerobic performance after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
state: Comunity Of Madrid
Study officials:
References: