Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory muscle strength training
Sponsored by
About this trial
This is an interventional other trial for Healthy
Eligibility Criteria
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.
Sites / Locations
- Universidad Francisco de Vitoria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Muscle inspiratory strength training
No training program
Arm Description
An 8-week muscle inspiratory muscle strength training
No intervention
Outcomes
Primary Outcome Measures
Diaphragm muscle thickness
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Secondary Outcome Measures
Inspiratory muscle strength
Inspiratory muscle strength will be measured in % by a POWER-breathe device
Physical Efficiency Index
Physical efficiency Index will be obtained by the Harvard Test
Full Information
NCT ID
NCT04832165
First Posted
March 29, 2021
Last Updated
June 16, 2022
Sponsor
Universidad Francisco de Vitoria
1. Study Identification
Unique Protocol Identification Number
NCT04832165
Brief Title
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function
Official Title
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function in Healthy Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Muscle inspiratory strength training
Arm Type
Experimental
Arm Description
An 8-week muscle inspiratory muscle strength training
Arm Title
No training program
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle strength training
Intervention Description
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 Outcome Measure Information:
Title
Diaphragm muscle thickness
Description
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Time Frame
Change from baseline diaphragm muscle thickness at 8 weeks
Secondary Outcome Measure Information:
Title
Inspiratory muscle strength
Description
Inspiratory muscle strength will be measured in % by a POWER-breathe device
Time Frame
Change from baseline inspiratory muscle strength at 8 weeks
Title
Physical Efficiency Index
Description
Physical efficiency Index will be obtained by the Harvard Test
Time Frame
Change from baseline physical efficiency index at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berlanga
Organizational Affiliation
Universidad Francisco de Vitoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function
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