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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02604147
Other study ID # UNIMEP
Secondary ID
Status Completed
Phase N/A
First received September 25, 2015
Last updated May 12, 2016
Start date January 2014
Est. completion date August 2014

Study information

Verified date May 2016
Source Universidade Metodista de Piracicaba
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Metodista de Piracicaba

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Pulmonary Function 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 Yes
Secondary Respiratory Muscle Strength 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 Yes
Secondary Thoracic mobility The thoracic mobility will be measured by the thoracic cirtometry. 3 months Yes
Secondary Heart rate variability The heart rate variability will be measured with a Polar RS800CX® heart rate monitor (Polar Electro Co.Ltda. Kempele, Oulu, Finland). 3 months Yes
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