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临床试验/NCT06271876
NCT06271876尚未招募不适用

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

Sierra Varona SL0 个研究点目标入组 18 人开始时间: 2024年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
主要终点
Diaphragm movement curve

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Inspiratory muscle fatigue 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.

干预措施: Inspiratory muscle training (Other)

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)

Inspiratory muscle 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.

干预措施: Inspiratory muscle training (Other)

结局指标

主要结局

Diaphragm movement curve

时间窗: 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.

Respiratory muscle strength

时间窗: 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.

Diaphragmatic thickness and thickening fraction

时间窗: 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.

Vertical jump performance

时间窗: Pre intervention and immediately post intervention

The 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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