- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02604147
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
Completed
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
Interventional
Enrollment (Actual)
24
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Simulated inspiratory muscle training
Inspiratory muscle training with load of 15% of maximal inspiratory pressure.
|
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:
|
|
Experimental: Inspiratory muscle training group
Inspiratory muscle training with initial load of 50% of maximal inspiratory pressure.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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.
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
January 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 25, 2015
First Submitted That Met QC Criteria
November 12, 2015
First Posted (Estimate)
November 13, 2015
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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