Reactive Airways Dysfunction Syndrome (Disorder)PEAKNCT03062735
Efficacy of Inspiratory Muscle Training on Elite Swimmers
A study testing Inspiratory Muscle Training in people with Reactive Airways Dysfunction Syndrome (Disorder) and Muscle Weakness, run by Universidade do Porto at 1 site in Portugal.
Trial summary
This study is a randomized controlled trial on the efficacy of inspiratory muscle training on swimming performance, airway dysfunction and perceived breathlessness in elite swimmers. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reactive Airways Dysfunction Syndrome (Disorder), Muscle Weakness, Dyspnea
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Feb 2017to May 2017
- 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 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy elite swimmers engaged in competitive training for a minimum period of three years;
- Individuals with no disability;
- Individuals aged between 14 and 40 years.
Who cannot join
- Individuals presenting co-morbidities or physical impairment that affects regular training;
- Smokers;
- Athletes already in a regular respiratory muscle training program
- Individuals with a predicted forced expiratory volume in the first second (FEV1) below 60%.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Medicine of Porto University
Porto, Porto District, 4200-319
André Moreira, MD, PhD, 00351932730090, andremoreira@med.up.pt
About this study
Official title: Protocol for a Randomized Controlled Trial Evaluating the Efficacy of Inspiratory Muscle Training on Swimming Performance, Airway Dysfunction and Perceived Breathlessness in Elite Swimmers
This study is a randomized controlled trial on the efficacy of inspiratory muscle training on swimming performance, airway dysfunction and perceived breathlessness in elite swimmers.
Read the detailed description
Only a few studies have assessed the impact of Inspiratory Muscle Training (IMT) on swim performance with unclear and inconsistent results. This study aims to evaluate the effect of a 12-week IMT program in swimming performance, airway dysfunction and perceived breathlessness among elite swimmers. Participants will be recruited from the elite competitive Futebol Clube do Porto swimming team. After consent, individuals will be randomly allocated into the IMT or Sham-IMT group. A pressure threshold device will be used to perform the inspiratory training. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice a day, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP). Sham-IMT group will follow a similar protocol, except for the inspiratory effort that will be made against 15% of MIP. Measures of lung function, swimming performance, airway dysfunction, inspiratory muscle strength and perceived breathlessness will be assessed at the beginning and then in 4 weeks intervals until the end of study period. All outcome measures will be assessed by an investigator who will be not involved in the intervention process. Data will be expressed as mean ± standard deviation (SD) and respective 95% confidence interval. The significance level will be 5% (p˂0.05).
- Being tested
- Inspiratory Muscle Training, Sham Inspiratory Muscle Training
- Medical subject headings
- Muscle Weakness, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
The Inspiratory Muscle Training (IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure.
Sham Inspiratory Muscle TrainingOther
The Sham Inspiratory Muscle Training (Sham-IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 15% of maximal inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Inspiratory Muscle Training intervention (Sham-IMT) groups during a 3 months training season. A pressure threshold device (POWERbreathe - HaB International Ltd., UK) will be used to IMT. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice daily, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP). Receives: Other: Inspiratory Muscle Training |
| Sham Inspiratory Muscle Training | Sham comparator | Sham-IMT group will follow a similar protocol, except the inspiratory effort that will be made against 15% MIP. The duration of each IMT session will be 30 inspirations. After the initial setting of training loads, the IMT group will be instructed to periodically increase load so that only 30 maneuvers could be completed. The Sham-IMT group will not receive these instructions. All the IMT sessions, in both groups will take place before swimming training and will be supervised throughout the intervention period to ensure that technique and load will be appropriate. Receives: Other: Sham Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swimming time trials performance
Changes in time-trial swim performance
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start6 Feb 2017
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reactive Airways Dysfunction Syndrome (Disorder)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Moreira, MD, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062735
- Sponsor's protocol ID
- PEAKNORTE-01-0145-FEDER-000010
- Acronym
- PEAK
- Status last verified
- Nov 2016
- First submitted
- 20 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized Controlled Trial Evaluating the Efficacy of Inspiratory Muscle Training on Swimming Performance, Airway Dysfunction and Perceived Breathlessness in Elite Swimmers
- ClinicalTrials.gov ID
- NCT03062735
- Acronym / sponsor ID
- PEAK / PEAKNORTE-01-0145-FEDER-000010
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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 is a randomized controlled trial on the efficacy of inspiratory muscle training on swimming performance, airway dysfunction and perceived breathlessness in elite swimmers.
Detailed description
Only a few studies have assessed the impact of Inspiratory Muscle Training (IMT) on swim performance with unclear and inconsistent results. This study aims to evaluate the effect of a 12-week IMT program in swimming performance, airway dysfunction and perceived breathlessness among elite swimmers. Participants will be recruited from the elite competitive Futebol Clube do Porto swimming team. After consent, individuals will be randomly allocated into the IMT or Sham-IMT group. A pressure threshold device will be used to perform the inspiratory training. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice a day, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP). Sham-IMT group will follow a similar protocol, except for the inspiratory effort that will be made against 15% of MIP. Measures of lung function, swimming performance, airway dysfunction, inspiratory muscle strength and perceived breathlessness will be assessed at the beginning and then in 4 weeks intervals until the end of study period. All outcome measures will be assessed by an investigator who will be not involved in the intervention process. Data will be expressed as mean ± standard deviation (SD) and respective 95% confidence interval. The significance level will be 5% (p˂0.05).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Other: Inspiratory Muscle TrainingInspiratory Muscle Training intervention (Sham-IMT) groups during a 3 months training season. A pressure threshold device (POWERbreathe - HaB International Ltd., UK) will be used to IMT. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice daily, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP). |
| Sham Inspiratory Muscle Training | Sham comparator | Other: Sham Inspiratory Muscle TrainingSham-IMT group will follow a similar protocol, except the inspiratory effort that will be made against 15% MIP. The duration of each IMT session will be 30 inspirations. After the initial setting of training loads, the IMT group will be instructed to periodically increase load so that only 30 maneuvers could be completed. The Sham-IMT group will not receive these instructions. All the IMT sessions, in both groups will take place before swimming training and will be supervised throughout the intervention period to ensure that technique and load will be appropriate. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy elite swimmers engaged in competitive training for a minimum period of three years;
- Individuals with no disability;
- Individuals aged between 14 and 40 years.
Key exclusion criteria (4 listed)
- Individuals presenting co-morbidities or physical impairment that affects regular training;
- Smokers;
- Athletes already in a regular respiratory muscle training program
- Individuals with a predicted forced expiratory volume in the first second (FEV1) below 60%.
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 Muscle TrainingThe Inspiratory Muscle Training (IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure. | Other | Inspiratory Muscle Training |
| Sham Inspiratory Muscle TrainingThe Sham Inspiratory Muscle Training (Sham-IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 15% of maximal inspiratory pressure. | Other | Sham Inspiratory Muscle Training |
Primary outcome
Swimming time trials performance
Time frame: twelve weeks
Changes in time-trial swim performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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.
André Moreira, MD, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Reactive Airways Dysfunction Syndrome (Disorder) and Muscle Weakness, run by Universidade do Porto at 1 site in Portugal.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marisa Cunha, MSc (00351914955278, anamarisa_c@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swimming time trials performance (time frame: twelve weeks). 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 23 Feb 2017.