Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Stren… (NCT06278714) | Clinical Trial Compass
UnknownNot Applicable
Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability
18 participantsStarted 2024-03-04
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Respiratory muscle strength
Timeframe: Pre intervention and immediately post intervention
2
Diaphragmatic thickness and thickening fraction
Timeframe: Pre intervention and immediately post intervention
3
Diaphragm movement curve
Timeframe: Pre intervention and immediately post intervention
4
Heart rate variability
Timeframe: Pre intervention and immediately post intervention