- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383900
Inspiratory Muscle Training (EMI) on Inspiratory Muscle Strength, Pulmonary Capacity and Performance in Soccer Players
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Murcia, Spain, 30107
- Catholic University San Antonio of Murcia
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Murcia, Spain, 30835
- Mayayo Sports Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Soccer players
Exclusion Criteria:
- Soccer players with disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G-IMT
The 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
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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.
Other Names:
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Placebo Comparator: Gn-IMT
The Gn-IMT will use by an inspiratory muscle training program use resistance loads up to 20% PImax during the 8 weeks.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RESPIRATORY CAPACITY
Time Frame: 1 week
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The variable PImax.
will be measured through spirometry whose value will be expressed in cm / H2O
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biofotogrametry
Time Frame: 1 week
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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 (%). |
1 week
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Sports performance
Time Frame: 1 week
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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.
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1 week
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Lactate in blood
Time Frame: 1 week
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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.
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1 week
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Static equilibrium
Time Frame: 1 week
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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
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1 week
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martha C León Garzón, Therapy, Catholic University San Antonio of Murcia
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMAFI-12/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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