NCT04286074

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

February 25, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

Breathing exercisesSoccerMaximal respiratory pressuresMuscle StrengthMuscle fatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (3)

  • 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

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: 50% resistance

Control group

ACTIVE COMPARATOR

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

Other: 10% resistance

Interventions

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

Also known as: Experimental group
Experimental group

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

Also known as: Control group
Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

multidrug resistance protein 50, DrosophilaControl Groups

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 26, 2020

Study Start

March 1, 2020

Primary Completion

May 1, 2020

Study Completion

June 10, 2020

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations