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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Inspiratory muscle strength training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Universidad Francisco de Vitoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle inspiratory strength training; An 8-week muscle inspiratory muscle strength training	Other: Inspiratory muscle strength training; 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.
No Intervention: No training program; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm muscle thickness	Diaphragm muscle thickness will be measured in mm by an ultrasound device	Change from baseline diaphragm muscle thickness at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory muscle strength	Inspiratory muscle strength will be measured in % by a POWER-breathe device	Change from baseline inspiratory muscle strength at 8 weeks
Physical Efficiency Index	Physical efficiency Index will be obtained by the Harvard Test	Change from baseline physical efficiency index at 8 weeks

Collaborators and Investigators

• Sponsor: Universidad Francisco de Vitoria
• Investigators: Principal Investigator: Berlanga, Universidad Francisco de Vitoria

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 14/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No