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NCT Number: NCT05542069

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

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Key information

Conditions

Sports Physical Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Basilea

Buenos Aires, 1078, Argentina

Location status: Recruiting

Location contact

Fernando Planells, MD

CONTACT

[email protected]

541144748928

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • older than 18 years
  • healthy subjects

Exclusion criteria

  • without anticoagulation
  • without esophageal lesions
  • without airway lesions
  • without spirometry alterations

Treatment and study plan

Threshold IMT (Inspiratory muscle trainer) by Philips

Device

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia Matesa, PT

CONTACT

[email protected]

541159567515

Sponsors and collaborators

Lead sponsor

Clínica Basilea

Other

Registry information

Official study title

Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 15, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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