NCT02650882

Brief Summary

This study investigated the effects of an inspiratory muscle training (IMT) program on the respiratory muscle strength and resistance and the aerobic physical performance (PP) of handball athletes. Nineteen male athletes took part in the study, allocated at random into the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted to an IMT protocol 5 times a week for 12 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Status
completed

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

April 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

November 10, 2015

Last Update Submit

January 7, 2016

Conditions

Keywords

Respiratory musclesathletic performancehandball

Outcome Measures

Primary Outcomes (3)

  • Effect of inspiratory muscle training on the respiratory muscle strength performed using a manometer and measured with cmH20

    The evaluation of respiratory muscle strength (RMS) was performed using a manometer and measured with cmH20

    Finalized study (24 weeks)

  • Effect of inspiratory muscle training on the muscular respiratory resistance evaluated by maximum voluntary ventilation (MVV) carried out with a spirometer

    The muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) carried out with a spirometer

    Finalized study (24 weeks)

  • Effect of inspiratory muscle training on the aerobic physical performance (PP) using cardiopulmonary test (CPT), and measured by VO2max

    The evaluation of aerobic performance was carried out using cardiopulmonary test (CPT), and measured by VO2max

    Finalized study (24 weeks)

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo group (PG) Nine athletes who maintained their regular sporting activities and were submitted to the IMT program for 12 weeks with a fixed load at 15% MIP, placebo protocol.

Procedure: Device POWERbreathe

Experimental

EXPERIMENTAL

Experimental group (EG) Ten athletes who maintained their regular sporting activities and were submitted to the IMT program for 12 weeks with a progressive load at 60%, 70% and 80 % of MIP.

Procedure: Device POWERbreathe

Interventions

Experimentalplacebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male gender
  • competition level athlete for at least one year
  • regularly takes part in the training sessions

You may not qualify if:

  • smoke
  • shows signs of respiratory and/or cardiovascular diseases
  • use supplements and/or medication that influences physical performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2015

First Posted

January 8, 2016

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01