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Training of the Inspiratory Musculature in the Improvement of Inspiratory Strength and Muscle Recovery in Soccer Players

Primary Purpose

Breathing

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
50% resistance
10% resistance
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breathing focused on measuring Breathing exercises, Soccer, Maximal respiratory pressures, Muscle Strength, Muscle fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad Europea de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Each session will last 10 minutes, taking place 5 days a week, over a period of 6 weeks. The intervention will take place at the beginning of each training session. Prior to training, the muscle training technique will be performed against a resistance of 50% of the maximum inspiratory pressure of each athlete

Each session will last 10 minutes, taking place 5 days a week, over a period of 6 weeks. The intervention will take place at the beginning of each training session. Prior to training, the muscle training technique will be performed against a resistance of 10% of the maximum inspiratory pressure of each athlete

Outcomes

Primary Outcome Measures

Change from baseline inspiratory force after treatment and at month
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.

Secondary Outcome Measures

Change from baseline muscle recovery after treatment and at month
It will be done by measuring blood lactate concentration. The measurement protocol used was described by Coyle et al. A puncture will be made in the earlobe for blood measurement, using puncture lancets, while the results will be analyzed with a lactate analyzer, model Lactate Scout 4 (model Scout Lactate, EKF Diagnostics, Germany). The unit of measure is mmol / l. A lower concentration of lactate in the blood indicates a greater capacity for muscle recovery.
Change from baseline aerobic performance after treatment and at month
It will be done by applying the Cooper's 12-Minute Run test. With this test, the number of laps that the athlete is able to run in a period of 12 minutes, to an area of 300 meters, will be measured. The unit of measure is the number of turns that the player is able to perform, indicating a greater distance, a greater aerobic performance.
Change from baseline anaerobic performance after treatment and at month
It will be done by applying the Repeated Sprint Ability (RSA) test. With this test, the time it takes for the athlete to make 6 sprints of 40 meters (20 + 20) with 20 seconds of rest between each one will be measured. The unit of measure is temporary (seconds). Performing sprints in less time indicates greater anaerobic performance.

Full Information

First Posted
February 25, 2020
Last Updated
September 1, 2021
Sponsor
Investigación en Hemofilia y Fisioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT04286074
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 Lockdown
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Investigación en Hemofilia y Fisioterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing
Keywords
Breathing exercises, Soccer, Maximal respiratory pressures, Muscle Strength, Muscle fatigue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Each session will last 10 minutes, taking place 5 days a week, over a period of 6 weeks. The intervention will take place at the beginning of each training session. Prior to training, the muscle training technique will be performed against a resistance of 50% of the maximum inspiratory pressure of each athlete
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Each session will last 10 minutes, taking place 5 days a week, over a period of 6 weeks. The intervention will take place at the beginning of each training session. Prior to training, the muscle training technique will be performed against a resistance of 10% of the maximum inspiratory pressure of each athlete
Intervention Type
Other
Intervention Name(s)
50% resistance
Other Intervention Name(s)
Experimental group
Intervention Description
Prior to training, the muscle training technique will be performed. The objective of applying the intervention using the Powerbreathe® device is to produce an increase in inspiratory force. The technique will be performed with the athlete standing, holding the device with his hand and his lips sealed on the mouthpiece. After a full expiration, you will make a quick and deep inspiration. The principal investigator of the study will ensure that the technique is performed correctly. There will be 2 series of 30 maximum inspirations. These interventions will be faced with a resistance of 50% of the maximum inspiratory pressure of each athlete
Intervention Type
Other
Intervention Name(s)
10% resistance
Other Intervention Name(s)
Control group
Intervention Description
Prior to training, the muscle training technique will be performed. The objective of applying the intervention using the Powerbreathe® device is to produce an increase in inspiratory force. The technique will be performed with the athlete standing, holding the device with his hand and his lips sealed on the mouthpiece. After a full expiration, you will make a quick and deep inspiration. The principal investigator of the study will ensure that the technique is performed correctly. There will be 2 series of 30 maximum inspirations. These interventions will be faced with a resistance of 10% of the maximum inspiratory pressure of each athlete
Primary Outcome Measure Information:
Title
Change from baseline inspiratory force after treatment and at month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Outcome Measure Information:
Title
Change from baseline muscle recovery after treatment and at month
Description
It will be done by measuring blood lactate concentration. The measurement protocol used was described by Coyle et al. A puncture will be made in the earlobe for blood measurement, using puncture lancets, while the results will be analyzed with a lactate analyzer, model Lactate Scout 4 (model Scout Lactate, EKF Diagnostics, Germany). The unit of measure is mmol / l. A lower concentration of lactate in the blood indicates a greater capacity for muscle recovery.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline aerobic performance after treatment and at month
Description
It will be done by applying the Cooper's 12-Minute Run test. With this test, the number of laps that the athlete is able to run in a period of 12 minutes, to an area of 300 meters, will be measured. The unit of measure is the number of turns that the player is able to perform, indicating a greater distance, a greater aerobic performance.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline anaerobic performance after treatment and at month
Description
It will be done by applying the Repeated Sprint Ability (RSA) test. With this test, the time it takes for the athlete to make 6 sprints of 40 meters (20 + 20) with 20 seconds of rest between each one will be measured. The unit of measure is temporary (seconds). Performing sprints in less time indicates greater anaerobic performance.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Universidad Europea de Madrid
City
Madrid
State/Province
Comunity Of Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

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Training of the Inspiratory Musculature in the Improvement of Inspiratory Strength and Muscle Recovery in Soccer Players

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