Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation

Healthy Clinical Trial

Official title:

Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271876
• Other study ID #: 0011
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: March 19, 2024

Study information

• Verified date: February 2024
• Source: Sierra Varona SL
• Contact: SIerra V SL
• Phone: 609956893
• Email: albertosanchezsierra77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and muscular strength in lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure and muscle tissue oxygen levels. According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence muscular strength, exercise capacity and muscle tissue oxygenation. In this study, subjects will be divided into three groups: experimental group , activation group and control group. Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and vertical jump performance, will be conducted.

Description:

This is a randomized control trial. Experimental group (EG) will perform an inspiratory muscle fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their Maximum Inspiratory Pressure (MIP) through a threshold valve device. Participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts. Activation group (AG) will perform a protocol of 2 sets of 30 repetitions at 40% of their MIP, one-on-one, and in a single session, using a threshold valve device. Control group will do a seat and wait. Interventions will be supervised by a physiotherapist. Primary outcomes will be: Muscle oxygen saturation (SmO2) will be assessed using a near infrared spectroscopy device, immediately before intervention and immediately after intervention. Vertical jump performance will be assessed by Counter Movement Jump (CMJ) test. CMJ test involved starting from a standing position with hands placed on hips, followed by a rapid upward jump achieved by flexing and extending knees. This plyometric action followed sequence of "eccentric - isometric - concentric" movements. CMJ measurements were taken using a force platform. This will be done immediately before intervention and immediately after intervention Respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring cross sectional area of diaphragm at 8-9th rib level and speed of contraction with a deep and fast inspiratory manoeuver. This will be done immediately before intervention and immediately after intervention

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: March 19, 2024
• Est. primary completion date: March 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Aged between 18-45 years.
• Non-smoker.
• Engaged in sports activity at least 3 times a week for a minimum of one year.

Exclusion Criteria:

• Having a medical condition that impedes engaging in physical activity.
• Individuals with compromised cognitive capacities.
• Subjects with any chronic disease (cardiorespiratory, neurological, metabolic, oncological, etc.).
• Subjects with tympanic perforation or middle-inner ear pathology.
• Subjects who have undergone lower limb surgery within the past 12 months.
• Subjects experiencing an active episode of lower limb pain.

Related Conditions & MeSH terms

• Fatigue
• Healthy

Intervention

Other:
• Inspiratory muscle training
The subjects will perform deep inspirations against a threshold device with varying resistances

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sierra Varona SL	Universidad Europea de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength	It will be assessed using a MicroRPM® (MicroMedical, UK).The MicroRPM® is likely a respiratory pressure meter or manometer designed for measuring respiratory muscle strength. It typically includes a mouthpiece connected to a pressure sensor, and the device measures the force or pressure generated during respiratory maneuvers.; The person will be instructed to take a maximal deep breath in, and then exhale to residual volume. After that, they will be asked to inhale forcefully against the resistance provided by the MicroRPM®. This measures the strength of the inspiratory muscles.; The measures will be expressed in cmH2O.	Pre intervention and immediately post intervention
Primary	Diaphragmatic thickness and thickening fraction	Diaphragmatic thickness and thickening fraction The linear array probe with a frequency of 3.0-10 megahertz (MHz) is placed perpendicularly to chest wall close to the mid-axillary line which is between the 8th and 10th intercostal space. The thickness of diaphragm is measured at the end of expiration and maximum inspiration for three times and the average values were recorded.; The measures will be expressed in centimeters.	Pre intervention and immediately post intervention
Primary	Diaphragm movement curve	The convex array probe with a frequency of 1.5-4.6 MHz is placed below the midclavicular line of the right costal margin in longitudinal scanning plane. The liver was used as an inspection window, and the probe was pointed toward the cephalic side. The ultrasound bundle is perpendicular to the posterior third of the right diaphragm. M-mode ultrasound is used to record the diaphragmatic movement curve during quiet breathing (QB) and deep breathing (DB).; The measures will be expressed in seconds.	Pre intervention and immediately post intervention
Primary	Vertical jump performance	The Counter Movement Jump (CMJ) test involved starting from a standing position with hands placed on the hips, followed by a rapid upward jump achieved by flexing and extending the knees. This plyometric action followed the sequence of "eccentric - isometric - concentric" movements. The CMJ measurements were taken using the force platform	Pre intervention and immediately post intervention