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Efficacy of Inspiratory Muscle Training on Elite Swimmers (PEAK)

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ClinicalTrials.gov Identifier: NCT03062735
Recruitment Status : Unknown
Verified November 2016 by Universidade do Porto.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Brief Summary:
This study is a randomized controlled trial on the efficacy of inspiratory muscle training on swimming performance, airway dysfunction and perceived breathlessness in elite swimmers.

Condition or disease Intervention/treatment Phase
Reactive Airways Dysfunction Syndrome (Disorder) Muscle Weakness Dyspnea Other: Inspiratory Muscle Training Other: Sham Inspiratory Muscle Training Not Applicable

Detailed Description:
Only a few studies have assessed the impact of Inspiratory Muscle Training (IMT) on swim performance with unclear and inconsistent results. This study aims to evaluate the effect of a 12-week IMT program in swimming performance, airway dysfunction and perceived breathlessness among elite swimmers. Participants will be recruited from the elite competitive Futebol Clube do Porto swimming team. After consent, individuals will be randomly allocated into the IMT or Sham-IMT group. A pressure threshold device will be used to perform the inspiratory training. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice a day, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP). Sham-IMT group will follow a similar protocol, except for the inspiratory effort that will be made against 15% of MIP. Measures of lung function, swimming performance, airway dysfunction, inspiratory muscle strength and perceived breathlessness will be assessed at the beginning and then in 4 weeks intervals until the end of study period. All outcome measures will be assessed by an investigator who will be not involved in the intervention process. Data will be expressed as mean ± standard deviation (SD) and respective 95% confidence interval. The significance level will be 5% (p˂0.05).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Protocol for a Randomized Controlled Trial Evaluating the Efficacy of Inspiratory Muscle Training on Swimming Performance, Airway Dysfunction and Perceived Breathlessness in Elite Swimmers
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inspiratory Muscle Training
Inspiratory Muscle Training intervention (Sham-IMT) groups during a 3 months training season. A pressure threshold device (POWERbreathe - HaB International Ltd., UK) will be used to IMT. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice daily, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP).
Other: Inspiratory Muscle Training
The Inspiratory Muscle Training (IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure.

Sham Comparator: Sham Inspiratory Muscle Training
Sham-IMT group will follow a similar protocol, except the inspiratory effort that will be made against 15% MIP. The duration of each IMT session will be 30 inspirations. After the initial setting of training loads, the IMT group will be instructed to periodically increase load so that only 30 maneuvers could be completed. The Sham-IMT group will not receive these instructions. All the IMT sessions, in both groups will take place before swimming training and will be supervised throughout the intervention period to ensure that technique and load will be appropriate.
Other: Sham Inspiratory Muscle Training
The Sham Inspiratory Muscle Training (Sham-IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 15% of maximal inspiratory pressure.




Primary Outcome Measures :
  1. Swimming time trials performance [ Time Frame: twelve weeks ]
    Changes in time-trial swim performance



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy elite swimmers engaged in competitive training for a minimum period of three years;
  • Individuals with no disability;
  • Individuals aged between 14 and 40 years.

Exclusion Criteria:

  • Individuals presenting co-morbidities or physical impairment that affects regular training;
  • Smokers;
  • Athletes already in a regular respiratory muscle training program
  • Individuals with a predicted forced expiratory volume in the first second (FEV1) below 60%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062735


Contacts
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Contact: Marisa Cunha, MSc 00351914955278 anamarisa_c@hotmail.com

Locations
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Portugal
Faculty of Medicine of Porto University Recruiting
Porto, Portugal, 4200-319
Contact: André Moreira, MD, PhD    00351932730090    andremoreira@med.up.pt   
Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: André Moreira, MD, PhD Faculty of Medicine of the University of Porto

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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03062735     History of Changes
Other Study ID Numbers: PEAKNORTE-01-0145-FEDER-000010
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases