Respiratory MusclesNCT02604147
Inspiratory Muscle Training in Wheelchair Basketball Players
A study testing Inspiratory pressure-threshold muscle training device. and nspiratory pressure-threshold muscle training device. in people with Respiratory Muscles and Breathing Exercises, run by Universidade Metodista de Piracicaba.
Trial summary
Investigate the effects of Inspiratory Muscle Training on the physical performance and cardiorespiratory variables of wheelchair basketball players. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscles, Breathing Exercises, Athletic Performance
- What is being tested?
- Inspiratory pressure-threshold muscle training device. and nspiratory pressure-threshold muscle training device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- training wheelchair basketball for more than one year.
Who cannot join
- cardiovascular or respiratory disease.
- motor or cognitive impairments that influencing the results of evaluations.
- smoking.
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Muscles, Breathing Exercises, Athletic Performance, Athletes, Aerobic Capacity
- Being tested
- Inspiratory pressure-threshold muscle training device., nspiratory pressure-threshold muscle training device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory pressure-threshold muscle training device.Device
Also called POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).
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.Device
Also called POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).
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.
| Study group | Role | What they receive |
|---|---|---|
| Simulated inspiratory muscle training | Sham comparator | Inspiratory muscle training with load of 15% of maximal inspiratory pressure. Receives: Device: Inspiratory pressure-threshold muscle training device. |
| Inspiratory muscle training group | Experimental | Inspiratory muscle training with initial load of 50% of maximal inspiratory pressure. Receives: Device: nspiratory pressure-threshold muscle training device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
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.
Measured: 3 months
Thoracic mobility
The thoracic mobility will be measured by the thoracic cirtometry.
Measured: 3 months
Heart rate variability
The heart rate variability will be measured with a Polar RS800CX® heart rate monitor (Polar Electro Co.Ltda. Kempele, Oulu, Finland).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MusclesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael do Nascimento Pereira, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604147
- Sponsor's protocol ID
- UNIMEP
- Status last verified
- May 2016
- First submitted
- 25 Sep 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Wheelchair Basketball Players: Effects on Physical Performance and Cardiopulmonary Variables
- ClinicalTrials.gov ID
- NCT02604147
- Acronym / sponsor ID
- UNIMEP
- Conditions
- Respiratory Muscles, Breathing Exercises, Athletic Performance, Athletes, Aerobic Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the effects of Inspiratory Muscle Training on the physical performance and cardiorespiratory variables of wheelchair basketball players.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulated inspiratory muscle training | Sham comparator | Device: Inspiratory pressure-threshold muscle training device.Inspiratory muscle training with load of 15% of maximal inspiratory pressure. |
| Inspiratory muscle training group | Experimental | Device: nspiratory pressure-threshold muscle training device.Inspiratory muscle training with initial load of 50% of maximal inspiratory pressure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- training wheelchair basketball for more than one year.
Key exclusion criteria (3 listed)
- cardiovascular or respiratory disease.
- motor or cognitive impairments that influencing the results of evaluations.
- smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory pressure-threshold muscle training device.Also: POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).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. | Device | Simulated inspiratory muscle training |
| nspiratory pressure-threshold muscle training device.Also: POWERbreathe - model Sports Plus Heavy Resistance (HAB International Ltd., Warwickshire, United Kingdom).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. | Device | Inspiratory muscle training group |
Primary outcome
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.
4 secondary outcomes
Pulmonary Function
Time frame: 3 months
Respiratory Muscle Strength
Time frame: 3 months
Thoracic mobility
Time frame: 3 months
Heart rate variability
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Related trials for Respiratory Muscles
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory pressure-threshold muscle training device. and nspiratory pressure-threshold muscle training device. in people with Respiratory Muscles and Breathing Exercises, run by Universidade Metodista de Piracicaba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.