Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability

NCT06278714 | Not Yet Recruiting DMC

• 1 other identifier: 0012
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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 maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability. According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function. In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group. Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Heart rate variability

  The analysis of Heart Rate Variability will be conducted using a heart rate monitor. Cardiac electrical signals will be monitored with a band placed on the chest for 5 minutes with the subject in supine position on a stretcher, in a quiet environment, soft light, and a comfortable temperature. Subjects are instructed not to speak or make voluntary movements during this analysis.

  Pre intervention and immediately post intervention

Study Arms (3)

Intervention group

EXPERIMENTAL

The EG (experimental group) will perform the diaphragmatic 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 MIP (Maximum Inspiratory Pressure) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts.

Other: Inspiratory muscle training

Control group

NO INTERVENTION

they will not receive any intervention. Just sit and wait the same amount of time that the intervention and the activation group needs to finish their protocol (around 10 minutes)

Activation group

ACTIVE COMPARATOR

The activation group will perform the protocol of 2 sets of 30 repetitions at 40% of their MIP, one-on-one, and in a single session, breathing against submaximal inspiratory loads using a threshold valve device. The participants will follow a free pattern of breathing until complete the protocol.

Other: Inspiratory muscle training

Interventions

Inspiratory muscle training OTHER

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

Also known as: Inspiratory muscle fatigue

Activation group; Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sierra Varona SL: lead
• Universidad Europea de Madrid: collaborator

Related Publications (1)

• Ladrinan-Maestro A, Sanchez-Infante J, Martin-Vera D, Sanchez-Sierra A. Influence of an inspiratory muscle fatigue protocol on healthy youths on respiratory muscle strength and heart rate variability. A randomized controlled trial. Front Physiol. 2024 Aug 23;15:1457019. doi: 10.3389/fphys.2024.1457019. eCollection 2024.

  PMID: 39247158 DERIVED

Study Officials

• Arturo Ladriñán Maestro

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SIerra V SL

CONTACT

609956893; albertosanchezsierra77@gmail.com

eva V sanz

CONTACT

608801238; praxisfisio@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 26, 2024
• Study Start: March 4, 2024
• Primary Completion: March 11, 2024
• Study Completion: March 20, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share