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

Sponsor
Universidad Francisco de Vitoria (Other)
Overall Status
Completed
CT.gov ID
NCT04832165
Collaborator
(none)
40
1
2
3.4
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Inspiratory muscle strength training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function in Healthy Young Adults
Actual Study Start Date :
Apr 4, 2021
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Diaphragm muscle thickness [Change from baseline diaphragm muscle thickness at 8 weeks]

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

Secondary Outcome Measures

  1. Inspiratory muscle strength [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 [Change from baseline physical efficiency index at 8 weeks]

    Physical efficiency Index will be obtained by the Harvard Test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Francisco de Vitoria Pozuelo de Alarcón Madrid Spain 28223

Sponsors and Collaborators

  • Universidad Francisco de Vitoria

Investigators

  • Principal Investigator: Berlanga, Universidad Francisco de Vitoria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad Francisco de Vitoria
ClinicalTrials.gov Identifier:
NCT04832165
Other Study ID Numbers:
  • 14/2021
First Posted:
Apr 5, 2021
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022