- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06278714
Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized control trial. The experimental group (EG) 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 Maximum Inspiratory Pressure (MIP) 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.
The activation group (AG) will perform the 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.
The control group will do a seat and wait.
The interventions will be supervised by a physiotherapist. The primary outcomes will be
Respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring the cross sectional area of the 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
Heart rate variability (HRV) will be assessed using a heart rate sensor Polar H10.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SIerra V SL
- Phone Number: 609956893
- Email: albertosanchezsierra77@gmail.com
Study Contact Backup
- Name: eva V sanz
- Phone Number: 608801238
- Email: praxisfisio@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
The subjects will perform deep inspirations against a threshold device with varying resistances
Other Names:
|
No Intervention: Control group
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)
|
|
Active Comparator: Activation group
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.
|
The subjects will perform deep inspirations against a threshold device with varying resistances
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle strength
Time Frame: Pre intervention and immediately post intervention
|
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
Time Frame: Pre intervention and immediately post intervention
|
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
Time Frame: Pre intervention and immediately post intervention
|
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
Time Frame: Pre intervention and immediately post intervention
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arturo Ladriñán Maestro, Universidad Europea de Madrid
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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