NCT03062735

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

February 20, 2017

Last Update Submit

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

EXPERIMENTAL

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

Sham Inspiratory Muscle Training

SHAM COMPARATOR

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

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.

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.

Sham Inspiratory Muscle Training

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Muscle WeaknessDyspnea

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Officials

  • André Moreira, MD, PhD

    Faculty of Medicine of the University of Porto

    PRINCIPAL INVESTIGATOR

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

Locations