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Efficacy of Inspiratory Muscle Training on Elite Swimmers (PEAK)

Primary Purpose

Reactive Airways Dysfunction Syndrome (Disorder), Muscle Weakness, Dyspnea

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sham Inspiratory Muscle Training
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Reactive Airways Dysfunction Syndrome (Disorder)

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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%.

Sites / Locations

  • Faculty of Medicine of Porto UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory Muscle Training

Sham Inspiratory Muscle Training

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Swimming time trials performance
Changes in time-trial swim performance

Secondary Outcome Measures

Full Information

First Posted
February 20, 2017
Last Updated
February 20, 2017
Sponsor
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT03062735
Brief Title
Efficacy of Inspiratory Muscle Training on Elite Swimmers
Acronym
PEAK
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reactive Airways Dysfunction Syndrome (Disorder), Muscle Weakness, Dyspnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Inspiratory Muscle Training
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Inspiratory Muscle Training
Intervention Description
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 Measure Information:
Title
Swimming time trials performance
Description
Changes in time-trial swim performance
Time Frame
twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa Cunha, MSc
Phone
00351914955278
Email
anamarisa_c@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Moreira, MD, PhD
Organizational Affiliation
Faculty of Medicine of the University of Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine of Porto University
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Moreira, MD, PhD
Phone
00351932730090
Email
andremoreira@med.up.pt

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Inspiratory Muscle Training on Elite Swimmers

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