Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266013
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-24
Brief Title:
Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength Muscle Oxygen Saturation and Functional Capacity
Sponsor:
Sierra Varona SL
Organization:
Sierra Varona SL
Study Overview
Official Title:
Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength Muscle Oxygen Saturation and Functional Capacity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None