NCT03383900

Brief 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. To assess the effects of inspiratory muscle training on lung function and sports performance in soccer players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

November 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

November 22, 2017

Last Update Submit

November 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • RESPIRATORY CAPACITY

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

    1 week

Secondary Outcomes (4)

  • Biofotogrametry

    1 week

  • Sports performance

    1 week

  • Lactate in blood

    1 week

  • Static equilibrium

    1 week

Study Arms (2)

G-IMT

EXPERIMENTAL

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

Device: Inspiratory muscle training

Gn-IMT

PLACEBO COMPARATOR

The Gn-IMT will use by an inspiratory muscle training program use resistance loads up to 20% PImax during the 8 weeks.

Device: Inspiratory muscle training

Interventions

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.

Also known as: G-IMT
G-IMTGn-IMT

Eligibility Criteria

Age18 Years - 22 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale soccer players
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Soccer players

You may not qualify if:

  • Soccer players with disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic University San Antonio of Murcia

Murcia, 30107, Spain

Location

Mayayo Sports Center

Murcia, 30835, Spain

Location

Related Publications (3)

  • 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.

    PMID: 28399624BACKGROUND
  • 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.

    PMID: 23722111BACKGROUND
  • 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.

    PMID: 18975258BACKGROUND

Study Officials

  • Martha C León Garzón, Therapy

    Catholic university San Antonio of Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor en Fisioterapia

Study Record Dates

First Submitted

November 22, 2017

First Posted

December 27, 2017

Study Start

January 30, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations