BreathingNCT04286074
Training of the Inspiratory Musculature in the Improvement of Inspiratory Strength and Muscle Recovery in Soccer Players
A study testing 50% resistance and 10% resistance in people with Breathing, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breathing
- What is being tested?
- 50% resistance and 10% resistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Football players
- Male
- With an age range of 18 to 35 years
- Which currently compete in the category of Spanish third division nationally.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Breathing
- Being tested
- 50% resistance, 10% resistance
- Keywords
- Breathing exercises, Soccer, Maximal respiratory pressures, Muscle Strength, Muscle fatigue
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% resistanceOther
Also called 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 50% of the maximum inspiratory pressure of each athlete
10% resistanceOther
Also called Control 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: 10% resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2020
- Primary completion1 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286074
- Sponsor's protocol ID
- IMT
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04286074
- Acronym / sponsor ID
- IMT
- Conditions
- Breathing
- Keywords
- Breathing exercises, Soccer, Maximal respiratory pressures, Muscle Strength, Muscle fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: 50% resistanceEach 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 |
| Control group | Active comparator | Other: 10% resistanceEach 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Football players
- Male
- With an age range of 18 to 35 years
- Which currently compete in the category of Spanish third division nationally.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50% resistanceAlso: Experimental groupPrior 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 | Other | Experimental group |
| 10% resistanceAlso: Control groupPrior 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 | Other | Control group |
Primary outcome
Change from baseline inspiratory force after treatment and at month
Time frame: 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.
3 secondary outcomes
Change from baseline muscle recovery after treatment and at month
Time frame: 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
Time frame: 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
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% resistance and 10% resistance in people with Breathing, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline inspiratory force after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.