Healthy Clinical Trial - Influence of an Inspiratory Muscle Fatigue

Status Not yet recruiting

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 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 older adults 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.

Clinical Trial 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 15% 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06269042
Study type	Interventional
Source	Sierra Varona SL
Contact	SIerra V SL
Phone	609956893
Email	albertosanchezsierra77@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2, 2024
Completion date	March 15, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms