Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2024-03-10

Brief Summary

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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 diaphragmatic fatigue and muscular strength in upper and lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, functionality and muscle tissue oxygen levels.

According to our hypothesis, the execution of a protocol inducing diaphragmatic fatigue in older adults could influence muscular strength, cardiorespiratory function, exercise capacity, and muscle tissue oxygenation.

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, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted.

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Detailed Description

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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

* Muscle oxygen saturation (SmO2) will be assessed using a near infrared spectroscopy device, immediately before intervention and immediately after intervention
* Functional mobility will be assessed using the Timed Up and Go Test (TUG) immediately before intervention and immediately after intervention
* 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
* Functional capacity will be assessed using the Five sit to Stand Test (5STS) Immediately before intervention and immediately after intervention.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type OTHER

The subjects will perform deep inspirations against a threshold device with varying resistances to observe the effect on the diaphragm and the musculature of the lower limbs.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

activation group

The activation group will perform the protocol of 2 sets of 30 repetitions at 15% 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.

Group Type ACTIVE_COMPARATOR

inspiratory muscle training

Intervention Type OTHER

The subjects will perform deep inspirations against a threshold device with varying resistances to observe the effect on the diaphragm and the musculature of the lower limbs.

Interventions

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inspiratory muscle training

The subjects will perform deep inspirations against a threshold device with varying resistances to observe the effect on the diaphragm and the musculature of the lower limbs.

Intervention Type OTHER

Other Intervention Names

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inspiratory muscle fatigue

Eligibility Criteria

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Inclusion Criteria

* • Being over 60 years old.

* Physical independence in terms of gait and transfers

Exclusion Criteria

* Having any pathology that prevents the performance of physical activity.

* Subjects with impaired cognitive abilities.
* Subjects with tympanic perforation or middle-inner ear pathology.
* Subjects with pulmonary hypertension, decompensated heart or respiratory failure.
* Subjects who have undergone lower limb surgery within the past 12 months.

Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes