Skip to main content
OpenTrials
Completed

NCT Number: NCT04832165

Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function

Fatigue of the respiratory muscles is one of the limitations of exercise at high intensity, although the mechanisms that explain it are not yet clear. This fatigue would cause a decrease in physical performance and could limit the functional capacity of the subject. In this sense, it has been shown that specific training of respiratory muscles, especially inspiratory muscles, improves their strength and resistance both in healthy people and in people with pathologies; managing to improve the quality of life and both physical and sports performance. This study, which follows the quantitative method and proposes an analytical, experimental, longitudinal and prospective design (with the aim of conducting a randomized clinical trial), proposes an intervention based on performing a specific training of inspiratory muscles for 8 weeks, taking 30 maximum inspirations at 60% of the PIM (maximum inspiratory pressure), 2 times a day for 5 days a week; with the aim of assessing the effects on inspiratory function, cardiorespiratory fitness when performing a stress test (Harvard step test) and diaphragm thickness measured by ultrasound. 40 healthy subjects between 18 and 25 years old will be recruited and divided into two groups: an experimental group (n = 20) and a control group (n = 20).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy university students

Exclusion criteria

  • Suffering or having suffered aortic aneurysm; pneumothorax; rib wall or pulmonary fistulas; recent trauma or surgery to the upper airway or thoracoabdominal; recent myocardial infarction or angina; retinal detachment, glaucoma, or recent eye surgery; increased intracranial pressure (tonsillar wedge, meningocele, hydrocephalus); abdominal hernias and acute middle ear problems.

Treatment and study plan

Inspiratory Muscle Strength Training

Other

Inspiratory muscle training during 8 weeks, 30 inspirations at 60% of the PIM (maximum inspiratory pressure), 2 times a day for 5 days per week.

Primary outcomes

  1. Diaphragm muscle thickness

    Time frame: Change from baseline diaphragm muscle thickness at 8 weeks

    Diaphragm muscle thickness will be measured in mm by an ultrasound device

Secondary outcomes

  1. Inspiratory muscle strength

    Time frame: Change from baseline inspiratory muscle strength at 8 weeks

    Inspiratory muscle strength will be measured in % by a POWER-breathe device

  2. Physical Efficiency Index

    Time frame: Change from baseline physical efficiency index at 8 weeks

    Physical efficiency Index will be obtained by the Harvard Test

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function in Healthy Young Adults

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Jun 21, 2022

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.

Published trials that share one or more normalized conditions with this study.