Inspiratory Muscle Training in Wheelchair Basketball Players

May 12, 2016 updated by: Raphael do Nascimento Pereira, Universidade Metodista de Piracicaba

Inspiratory Muscle Training in Wheelchair Basketball Players: Effects on Physical Performance and Cardiopulmonary Variables

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The respiratory system has been touted as a limiting factor of physical performance during high intense physical exercises. This limitation is related, among other things, with the fatigue of respiratory muscles. The fatigue of these muscles during physical exercise generates many physiological reflex activation culminating in reduced blood flow to the limb muscles, resulting in decrease in muscle performance. Researchers showed that the inspiratory muscle training (IMT) is able to generate improved of athlete's physical performance. However, when it comes to wheelchair athletes there are still divergent views on the effects of IMT on the physical performance. Thus, this study aims to evaluate the effects of IMT on the physical performance and cardiorespiratory variables of wheelchair basketball players. For this purpose, the investigators will select 40 wheelchair basketball players of both genders. The participants will be allocated blindly and randomly into two groups that differ by the proposed interventions. In IMT Group, the participants will be submitted to a IMT program with inicial load of 50% of maximal inspiratory pressure (MIP); the SHAM Group will be submitted to a simulated IMT with load of 15% of MIP. All participants will pass through the same evaluation procedures before and after the interventions, so that the investagators can evaluate the benefits generated by the IMT on the physical performance and cardiorespiratory variables of wheelchair basketball players.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • training wheelchair basketball for more than one year.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Simulated inspiratory muscle training
Inspiratory muscle training with load of 15% of maximal inspiratory pressure.
Device: Inspiratory pressure-threshold muscle training 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.
Other Names:
  • POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).
Experimental: Inspiratory muscle training group
Inspiratory muscle training with initial load of 50% of maximal inspiratory pressure.
Device: nspiratory pressure-threshold muscle training 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.
Other Names:
  • POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aerobic Capacity
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary Function
Time Frame: 3 months
The pulmonary function will be measured by a spirometer (Easy one, ndd Medizintechnik AG, Zurich, Switzerland) according to American Thoracic Society (ATS) guidelines for technique, acceptability and reproducibility.
3 months
Respiratory Muscle Strength
Time Frame: 3 months
The respiratory muscle strength values will be obtained by measuring maximal inspiratory and expiratory pressures (MIP and MEP) with an analog manometer (Ger-ar®, São Paulo, Brazil) scaled in cmH2O with an operational limit of ± 300 cmH2O.
3 months
Thoracic mobility
Time Frame: 3 months
The thoracic mobility will be measured by the thoracic cirtometry.
3 months
Heart rate variability
Time Frame: 3 months
The heart rate variability will be measured with a Polar RS800CX® heart rate monitor (Polar Electro Co.Ltda. Kempele, Oulu, Finland).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Metodista de Piracicaba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNIMEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Athletic Performance

Clinical Trials on Inspiratory pressure-threshold muscle training device.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings