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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06271876
Enrollment
18
Registered
2024-02-22
Start date
2024-03-03
Completion date
2024-03-19
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Detailed 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

Interventions

OTHERInspiratory muscle training

The subjects will perform deep inspirations against a threshold device with varying resistances

Sponsors

Universidad Europea de Madrid
CollaboratorOTHER
Sierra Varona SL
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strengthPre intervention and immediately post interventionIt 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.
Diaphragmatic thickness and thickening fractionPre intervention and immediately post interventionDiaphragmatic 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.
Diaphragm movement curvePre intervention and immediately post interventionThe 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.
Vertical jump performancePre intervention and immediately post interventionThe 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

Contacts

Primary ContactSIerra V SL
albertosanchezsierra77@gmail.com609956893
Backup Contacteva V sanz
praxisfisio@hotmail.com608801238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026