Measurement of the Diaphragm Loading During the Training With a IMT Device

NCT ID: NCT05542069

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-06

Study Completion Date

2025-03-30

Brief Summary

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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

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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

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Sports Physical Therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Threshold IMT (Inspiratory muscle trainer) by Philips

Apply a resistive load with the IMT device according the maximal inspiratory pressure of each subject.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* older than 18 years
* healthy subjects

Exclusion Criteria

* without anticoagulation
* without esophageal lesions
* without airway lesions
* without spirometry alterations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clínica Basilea

OTHER

Sponsor Role lead

Responsible Party

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Dario Villalba

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dario Villalba, PT

Role: STUDY_DIRECTOR

Clinica Basilea

Locations

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Clinica Basilea

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Amelia Matesa, PT

Role: CONTACT

541159567515

Facility Contacts

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Fernando Planells, MD

Role: primary

541144748928

Other Identifiers

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Basilea00000000000000001

Identifier Type: -

Identifier Source: org_study_id

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