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

NCT04832165 | Completed

• 1 other identifier: 14/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Inspiratory muscle strength

  Change from baseline inspiratory muscle strength at 8 weeks

• Physical Efficiency Index

  Change from baseline physical efficiency index at 8 weeks

Study Arms (2)

Muscle inspiratory strength training

EXPERIMENTAL

An 8-week muscle inspiratory muscle strength training

Other: Inspiratory muscle strength training

No training program

NO INTERVENTION

No intervention

Interventions

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.

Muscle inspiratory strength training

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy university students

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Study Officials

• Berlanga

  Universidad Francisco de Vitoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 5, 2021
• Study Start: April 4, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 15, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)