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Breathing Exercises: Inspiratory Muscle TrainingNCT03383900

Inspiratory Muscle Training (EMI) on Inspiratory Muscle Strength, Pulmonary Capacity and Performance in Soccer Players

A study testing Inspiratory muscle training in people with Breathing Exercises: Inspiratory Muscle Training, run by Grupo de Investigacion en Fisioterapia Cardiovascular y Respiratoria at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The training of the respiratory muscles seems to be fundamental in people who require a high physical demand. There is abundant scientific evidence that relates the respiratory variables and the limitation to exercise. The published studies are athletics and cycling, however it is scarce in football. Objective. Read more about this study

Who is it for?
Ages 18 to 22 years, men onlyHealthy volunteers can take part
What is being tested?
Inspiratory muscle training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
2 sitesSpain
Study dates
30 Jan 2018to 30 Jul 2018
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 22 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Soccer players

Who cannot join

  • Soccer players with disabilities

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Catholic University San Antonio of Murcia

    Murcia, 30107

  • Mayayo Sports Center

    Murcia, 30835

Other trials in Spain

About this study

The training of the respiratory muscles seems to be fundamental in people who require a high physical demand. There is abundant scientific evidence that relates the respiratory variables and the limitation to exercise. The published studies are athletics and cycling, however it is scarce in football. Objective. To assess the effects of inspiratory muscle training on lung function and sports performance in soccer players.

Read the detailed description

Objective. To assess the effects of inspiratory muscle training (IMT) on lung function, inspiratory muscle strength and athletic performance in soccer players.

Method. Participants will be randomized into two groups: experimental and sham . The two groups will perform a protocol of 8 weeks of training (6 days / week) with the PowerBreathe device. The EG will use progressive resistance loads up to 80% of the MIP, while the SG will use the device with a minimum load (20% PImax) during the 8 weeks. All participants will have the following tests before and after the intervention and 3 months after the end of the program: spirometry (FVC, FEV1), PImax, biophotogrammetry, and fit 30/15 test. For the statistical analysis, a 2-factor variance analysis will be performed for repeated measures and Pearson's correlations. The statistical significance will be set with a value of p <0.05. The effect size will be calculated using the partial eta-square.

Being tested
Inspiratory muscle training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory muscle trainingDevice

    Also called G-IMT

    The inspiratory muscle training program will be of the "strength and endurance" type, using the POWERbreathe® device and composed of: daily sessions (3 sets of 15 repetitions -inspiration), 6 days a week for 8 weeks. Participants will begin training breathing with a resistance of 20% of their PImax during the first week. After the first week, the resistance will increase between 5% and 10% in each session until reaching 80% of the PImax, which will be maintained during the first month. Upon completion, the PImax value will be re-evaluated and the player will train 80% of this new value during the second month. At the end of the second month, the PImax is evaluated and the player will train the third month with a resistance of 80% of this new value.

Study groups in NCT03383900
Study groupRoleWhat they receive
G-IMTExperimentalThe experimental group will first carry out a diaphragmatic reeducation program, followed a posteriori by an inspiratory muscle training program use progressive resistance loads up to 80% of the PImax during the 8 weeks
Receives: Device: Inspiratory muscle training
Gn-IMTPlacebo comparatorThe Gn-IMT will use by an inspiratory muscle training program use resistance loads up to 20% PImax during the 8 weeks.
Receives: Device: Inspiratory muscle training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RESPIRATORY CAPACITY

    The variable PImax. will be measured through spirometry whose value will be expressed in cm / H2O

    Measured: 1 week

Secondary outcomes (4)

  1. Biofotogrametry

    Biofotogrametry is a tool used to measure the thoracic expansion, the respiratory pattern and its cadence; by recording a video of the breathing pattern that observes the pre- and post-breathing of the subjects.

    The unit of measurement in which the results are expressed for the variable thoracic extension will be in cm, and for the respiratory pattern and its percentage cadence (%).

    Measured: 1 week

  2. Sports performance

    The performance variable will be evaluated using the "fit" 30/15 test, a tool used in athletes to determine the maximum intermittent aerobic speed (VO2max); the results of this test allow later to plan the specific training protocol of the sports team.

    Measured: 1 week

  3. Lactate in blood

    The amount of blood lactate will be measured after inspiratory muscle training with a lactate meter, its results will be expressed in the unit of measure mg / dL.

    Measured: 1 week

  4. Static equilibrium

    Static equilibrium was obtained through an analysis of stabilometric variables on an equilibrium platform. The players had to stand on the platform with bipodal support (45º) for 90 seconds with eyes open and 90 seconds with eyes closed. During the measurement with their eyes open, the players had to keep their gaze on a fixed point that coincided with the height of their eyes and was about 2.5 meters from the platform. A FreeStep platform (Rome, Italy) was used

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2017
  2. Study start30 Jan 2018
  3. Primary completion30 Jun 2018
  4. Study completion30 Jul 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into two groups: experimental (G-IMT) and sham (Gn-IMT). The two groups will perform a protocol of 8 weeks of training (6 days / week) with the PowerBreath
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383900
Sponsor's protocol ID
PMAFI-12/16
Status last verified
Nov 2021
First submitted
22 Nov 2017
Last updated
26 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ozmen T, Gunes GY, Ucar I, Dogan H, Gafuroglu TU. Effect of respiratory muscle training on pulmonary function and aerobic endurance in soccer players. J Sports Med Phys Fitness. 2017 May;57(5):507-513. doi: 10.23736/S0022-4707.16.06283-6. Epub 2016 Feb 12.

    PubMed 28399624

  • Guy JH, Edwards AM, Deakin GB. Inspiratory muscle training improves exercise tolerance in recreational soccer players without concomitant gain in soccer-specific fitness. J Strength Cond Res. 2014 Feb;28(2):483-91. doi: 10.1519/JSC.0b013e31829d24b0.

    PubMed 23722111

  • Nicks CR, Morgan DW, Fuller DK, Caputo JL. The influence of respiratory muscle training upon intermittent exercise performance. Int J Sports Med. 2009 Jan;30(1):16-21. doi: 10.1055/s-2008-1038794. Epub 2008 Oct 30.

    PubMed 18975258

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory muscle training in people with Breathing Exercises: Inspiratory Muscle Training, run by Grupo de Investigacion en Fisioterapia Cardiovascular y Respiratoria at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

RESPIRATORY CAPACITY (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03383900, which also lists 3 linked publications.

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 26 Nov 2021.

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