Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05542069

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

Led by Clínica Basilea · Updated on 2024-09-19

10

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the muscles involved during training with an Inspiratory Muscle Trainer (IMT) device in healthy adults. The study aims to measure diaphragm loading while using the IMT device at various resistive loads, as there is uncertainty about which muscles contribute most during this type of training. This observational study involves healthy volunteers and uses advanced pressure monitoring to gather detailed muscle activity data. Participants will use the Threshold IMT device by Philips, which applies resistive loads based on each person's maximal inspiratory pressure. The training involves random loads increasing by tens of percentages from 10% up to 100%, with each load maintained for five breaths. During this, esophageal and gastric pressures, as well as transdiaphragmatic pressure, are recorded to analyze diaphragm involvement. Throughout the study, each participant will be monitored using esophageal and gastric manometry while performing breathing efforts with the device. Data collected includes esophageal pressure, gastric pressure, and transdiaphragmatic pressure to calculate diaphragm collaboration at each load. The primary outcome focuses on diaphragm intervention during different resistive loads over one year, with safety and muscle function closely observed during the process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 18 years
  • Healthy subjects
Not Eligible

You will not qualify if you...

  • Using anticoagulation medication
  • Having esophageal lesions
  • Having airway lesions
  • Having abnormal lung function test results (spirometry)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single session

Participants use the inspiratory muscle trainer device with different randomized resistive loads while measurements of esophageal, gastric, and transdiaphragmatic pressures are recorded to assess diaphragm loading.

1 visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants are observed to assess diaphragm intervention outcomes over one year following the device use.

Follow-up assessments as scheduled

Trial Site Locations

Total: 1 location

1

Clinica Basilea

Buenos Aires, Argentina, 1078

Actively Recruiting

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Research Team

A

Amelia Matesa, PT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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