Athletic PerformanceNCT02650882
Effect of Inspiratory Muscle Training on the Performance of Handball Athletes
A study testing Device POWERbreathe in people with Athletic Performance, run by Universidade Metodista de Piracicaba.
Trial summary
This study investigated the effects of an inspiratory muscle training (IMT) program on the respiratory muscle strength and resistance and the aerobic physical performance (PP) of handball athletes. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Device POWERbreathe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Mar 2015
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male gender
- competition level athlete for at least one year
- regularly takes part in the training sessions
Who cannot join
- smoke
- shows signs of respiratory and/or cardiovascular diseases
- use supplements and/or medication that influences physical performance
About this study
This study investigated the effects of an inspiratory muscle training (IMT) program on the respiratory muscle strength and resistance and the aerobic physical performance (PP) of handball athletes. Nineteen male athletes took part in the study, allocated at random into the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted to an IMT protocol 5 times a week for 12 weeks.
Read the detailed description
The study was designed to evaluate the effects of a 12-week IMT program on the respiratory muscle strength and aerobic physical performance of handball players. Nineteen male athletes took part in the study, divided into the experimental group (EG), which took part in the evaluations, maintained their regular sporting activities and carried out the IMT (n=10), and the placebo group (PG), which took part in the evaluations, maintained their regular sporting activities and carried out an IMT with a load considered to be placebo (n=09), Experimental procedures were carried out by trained researchers and a qualified team. The evaluations and IMT were carried out during the competitive season, the training frequency being based on the competition program, following the traditional annual model.
The athletes were submitted to an initial evaluation composed of measuring the respiratory muscle strength (RMS) using a manovacuometer, and an evaluation of the aerobic physical performance carried out using the cardiopulmonary exercise test (CPET).
The athletes were reevaluated after 12 weeks for subsequent analysis and comparison with the initial values.
All the subjects were previously informed about the experimental procedures, and signed a free and clarified term of consent. The project was approved by the Ethics in Research Committee of the Institution with the number 62/13.
- Conditions
- Athletic Performance
- Being tested
- Device POWERbreathe
- Keywords
- Respiratory muscles, athletic performance, handball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device POWERbreatheProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo group (PG) Nine athletes who maintained their regular sporting activities and were submitted to the IMT program for 12 weeks with a fixed load at 15% MIP, placebo protocol. Receives: Procedure: Device POWERbreathe |
| Experimental | Experimental | Experimental group (EG) Ten athletes who maintained their regular sporting activities and were submitted to the IMT program for 12 weeks with a progressive load at 60%, 70% and 80 % of MIP. Receives: Procedure: Device POWERbreathe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of inspiratory muscle training on the respiratory muscle strength performed using a manometer and measured with cmH20
The evaluation of respiratory muscle strength (RMS) was performed using a manometer and measured with cmH20
Measured: Finalized study (24 weeks)
Effect of inspiratory muscle training on the muscular respiratory resistance evaluated by maximum voluntary ventilation (MVV) carried out with a spirometer
The muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) carried out with a spirometer
Measured: Finalized study (24 weeks)
Effect of inspiratory muscle training on the aerobic physical performance (PP) using cardiopulmonary test (CPT), and measured by VO2max
The evaluation of aerobic performance was carried out using cardiopulmonary test (CPT), and measured by VO2max
Measured: Finalized study (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlini Simoni Hartz, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650882
- Sponsor's protocol ID
- 62/13
- Status last verified
- Jan 2016
- First submitted
- 10 Nov 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on the Performance of Handball Athletes
- ClinicalTrials.gov ID
- NCT02650882
- Acronym / sponsor ID
- 62/13
- Conditions
- Athletic Performance
- Keywords
- Respiratory muscles, athletic performance, handball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Jan 2016 (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.
This study investigated the effects of an inspiratory muscle training (IMT) program on the respiratory muscle strength and resistance and the aerobic physical performance (PP) of handball athletes. Nineteen male athletes took part in the study, allocated at random into the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted to an IMT protocol 5 times a week for 12 weeks.
Detailed description
The study was designed to evaluate the effects of a 12-week IMT program on the respiratory muscle strength and aerobic physical performance of handball players. Nineteen male athletes took part in the study, divided into the experimental group (EG), which took part in the evaluations, maintained their regular sporting activities and carried out the IMT (n=10), and the placebo group (PG), which took part in the evaluations, maintained their regular sporting activities and carried out an IMT with a load considered to be placebo (n=09), Experimental procedures were carried out by trained researchers and a qualified team. The evaluations and IMT were carried out during the competitive season, the training frequency being based on the competition program, following the traditional annual model.
The athletes were submitted to an initial evaluation composed of measuring the respiratory muscle strength (RMS) using a manovacuometer, and an evaluation of the aerobic physical performance carried out using the cardiopulmonary exercise test (CPET).
The athletes were reevaluated after 12 weeks for subsequent analysis and comparison with the initial values.
All the subjects were previously informed about the experimental procedures, and signed a free and clarified term of consent. The project was approved by the Ethics in Research Committee of the Institution with the number 62/13.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Procedure: Device POWERbreathePlacebo group (PG) Nine athletes who maintained their regular sporting activities and were submitted to the IMT program for 12 weeks with a fixed load at 15% MIP, placebo protocol. |
| Experimental | Experimental | Procedure: Device POWERbreatheExperimental group (EG) Ten athletes who maintained their regular sporting activities and were submitted to the IMT program for 12 weeks with a progressive load at 60%, 70% and 80 % of MIP. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male gender
- competition level athlete for at least one year
- regularly takes part in the training sessions
Key exclusion criteria (3 listed)
- smoke
- shows signs of respiratory and/or cardiovascular diseases
- use supplements and/or medication that influences physical performance
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 |
|---|---|---|
| Device POWERbreathe | Procedure or surgery | Experimental, placebo |
Primary outcome
Effect of inspiratory muscle training on the respiratory muscle strength performed using a manometer and measured with cmH20
Time frame: Finalized study (24 weeks)
The evaluation of respiratory muscle strength (RMS) was performed using a manometer and measured with cmH20
Effect of inspiratory muscle training on the muscular respiratory resistance evaluated by maximum voluntary ventilation (MVV) carried out with a spirometer
Time frame: Finalized study (24 weeks)
The muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) carried out with a spirometer
Effect of inspiratory muscle training on the aerobic physical performance (PP) using cardiopulmonary test (CPT), and measured by VO2max
Time frame: Finalized study (24 weeks)
The evaluation of aerobic performance was carried out using cardiopulmonary test (CPT), and measured by VO2max
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 8 Jan 2016.
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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 Device POWERbreathe in people with Athletic Performance, 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 3 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 8 Jan 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?
Effect of inspiratory muscle training on the respiratory muscle strength performed using a manometer and measured with cmH20 (time frame: Finalized study (24 weeks)). The study lists 3 primary outcomes in all. 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 8 Jan 2016.