Efficacy of Inspiratory Muscle Training on Elite Swimmers
PEAK
Protocol for a Randomized Controlled Trial Evaluating the Efficacy of Inspiratory Muscle Training on Swimming Performance, Airway Dysfunction and Perceived Breathlessness in Elite Swimmers
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
February 6, 2017
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 23, 2017
November 1, 2016
2 months
February 20, 2017
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Swimming time trials performance
Changes in time-trial swim performance
twelve weeks
Study Arms (2)
Inspiratory Muscle Training
EXPERIMENTALInspiratory 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).
Sham Inspiratory Muscle Training
SHAM COMPARATORSham-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine of Porto University
Porto, Porto District, 4200-319, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
André Moreira, MD, PhD
Faculty of Medicine of the University of Porto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 23, 2017
Study Start
February 6, 2017
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
February 23, 2017
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share