Sports Physical TherapyNCT05542069
Measurement of the Diaphragm Loading During the Training With a IMT Device
An observational study of Sports Physical Therapy, run by Clínica Basilea at 1 site in Argentina.
Trial summary
It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Threshold IMT (Inspiratory muscle trainer) by Philips
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteArgentina
- Study dates
- 6 Feb 2024to 30 Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adult volunteers
Who may be able to join
- older than 18 years
- healthy subjects
Who cannot join
- without anticoagulation
- without esophageal lesions
- without airway lesions
- without spirometry alterations
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Clinica Basilea
Buenos Aires, 1078
Fernando Planells, MD, 541144748928, fmplanells@intramed.net
About this study
Official title: Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device
It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.
Read the detailed description
This study has a quasi-experimental design. The investigators will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form.
After checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).
- Conditions
- Sports Physical Therapy
- Being tested
- Threshold IMT (Inspiratory muscle trainer) by Philips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold IMT (Inspiratory muscle trainer) by PhilipsDevice
Apply a resistive load with the IMT device according the maximal inspiratory pressure of each subject.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm intervention during a certain percentage of resistive load with a IMT device
The diaphragm intervention is determined by the relation of the gastric pressure and the transdiaphragmatic pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start6 Feb 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Basilea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Villalba, Clínica Basilea
- Investigators
- Dario Villalba, PT, Study director, Clinica Basilea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542069
- Sponsor's protocol ID
- Basilea00000000000000001
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2022
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device
- ClinicalTrials.gov ID
- NCT05542069
- Acronym / sponsor ID
- Basilea00000000000000001
- Conditions
- Sports Physical Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Clínica BasileaUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 15 Sep 2022 (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.
It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.
Detailed description
This study has a quasi-experimental design. The investigators will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form.
After checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adult volunteers
Key inclusion criteria (2 listed)
- older than 18 years
- healthy subjects
Key exclusion criteria (4 listed)
- without anticoagulation
- without esophageal lesions
- without airway lesions
- without spirometry alterations
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 |
|---|---|---|
| Threshold IMT (Inspiratory muscle trainer) by PhilipsApply a resistive load with the IMT device according the maximal inspiratory pressure of each subject. | Device | – |
Primary outcome
Diaphragm intervention during a certain percentage of resistive load with a IMT device
Time frame: 1 year
The diaphragm intervention is determined by the relation of the gastric pressure and the transdiaphragmatic pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Sports Physical Therapy
Recruiting
Effects of Scapular Training on Adolescent Boxers
Sports Physical Therapy
Recruiting
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Recruiting
French Contrast Versus Oregon Circuit Training in Competitive Football Players
No Disease or Condition is Being Studied
Recruiting
Diaphragmatic Facilitation and Upper Extremity Performance in Volleyball Players
Volleyball Players
Recruiting
Comparative Effects of Dolphin Kick Streamline Training Versus Flutter Kick Training in Competitive Swimmers
Sports Physical Therapy
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.
Dario Villalba, PT study director
Clinica Basilea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Physical Therapy, run by Clínica Basilea at 1 site in Argentina.
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 2 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 19 Sep 2024. 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 Argentina. 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. 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 Amelia Matesa, PT (541159567515, ameliamatesa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm intervention during a certain percentage of resistive load with a IMT device (time frame: 1 year). 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 19 Sep 2024.