NCT02604147

Brief Summary

Investigate the effects of Inspiratory Muscle Training on the physical performance and cardiorespiratory variables of wheelchair basketball players.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 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

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

September 25, 2015

Last Update Submit

May 12, 2016

Conditions

Respiratory MusclesBreathing ExercisesAthletic PerformanceAthletesAerobic Capacity

Outcome Measures

Primary Outcomes (1)

  • Aerobic Capacity

    The evaluation of aerobic capacity will be conducted by the 12-minutes aerobic performance test in a multisport court. In this field test the participants will have to covering the greatest distance as possible in the twelve minutes in a suitably demarcated circuit. Heart rate, blood pressure, peripheral oxygen saturation and subjective perception of effort with the Borg scale will be measured in this test.

    3 months

Secondary Outcomes (4)

  • Pulmonary Function

    3 months

  • Respiratory Muscle Strength

    3 months

  • Thoracic mobility

    3 months

  • Heart rate variability

    3 months

Study Arms (2)

Simulated inspiratory muscle training

SHAM COMPARATOR

Inspiratory muscle training with load of 15% of maximal inspiratory pressure.

Device: Inspiratory pressure-threshold muscle training device.

Inspiratory muscle training group

EXPERIMENTAL

Inspiratory muscle training with initial load of 50% of maximal inspiratory pressure.

Device: nspiratory pressure-threshold muscle training device.

Interventions

Inspiratory pressure-threshold muscle training device.DEVICE

The participants who will be allocated in this simulated intervention group will have to do a simulated inspiratory muscle training protocol through the inspiratory muscle exerciser POWERbreathe, model Sports Plus Heavy Resistance (POWERbreathe; HAB International Ltd., Warwickshire, United Kingdom) for 12 weeks five times at week and twice daily, with a load of 15% of maximal inspiratory pressure without progression. In each session will be requested to the volunteers make 30 slow breaths, which will be constantly supervised by the researchers.

Also known as: POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).
Simulated inspiratory muscle training
nspiratory pressure-threshold muscle training device.DEVICE

The participants who will be allocated in this intervention group will have to make a inspiratory muscle training protocol with progressive loads through the inspiratory muscle exerciser POWERbreathe, model Sports Plus Heavy Resistance (POWERbreathe; HAB International Ltd., Warwickshire, United Kingdom) for 12 weeks five times at week and twice daily, with an initial load of 50% of maximal inspiratory pressure, progressing to 60% after the fourth week, and 70% after the octave week. In each session will be requested to volunteers who performed 30 maximal and prolonged inspiration, maintaining the diaphragmatic breathing, which will be constantly supervised by the researchers.

Also known as: POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).
Inspiratory muscle training group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • training wheelchair basketball for more than one year.

You may not qualify if:

  • cardiovascular or respiratory disease.
  • motor or cognitive impairments that influencing the results of evaluations.
  • smoking.

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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC.

Study Record Dates

First Submitted

September 25, 2015

First Posted

November 13, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

May 13, 2016

Record last verified: 2016-05