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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
- 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|
- 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.
- Individuals presenting co-morbidities or physical impairment that affects regular training;
- Athletes already in a regular respiratory muscle training program
- Individuals with a predicted forced expiratory volume in the first second (FEV1) below 60%.
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
|Contact: Marisa Cunha, MScemail@example.com|
|Faculty of Medicine of Porto University||Recruiting|
|Porto, Portugal, 4200-319|
|Contact: André Moreira, MD, PhD 00351932730090 firstname.lastname@example.org|
|Principal Investigator:||André Moreira, MD, PhD||Faculty of Medicine of the University of Porto|
|Responsible Party:||Universidade do Porto|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
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