HealthyNCT06266013
Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity
A study testing inspiratory muscle training in people with Healthy, run by Sierra Varona SL.
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. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2024to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Being over 60 years old.
- Physical independence in terms of gait and transfers
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
Also called inspiratory muscle fatigue
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention 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. Receives: Other: inspiratory muscle training |
| 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) |
| activation group | Active comparator | 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. Receives: Other: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygen saturation (SmO2)
is a physiological assessment that measures the saturation level of oxygen in muscles during exercise. it utilizes near-infrared spectroscopy (NIRS) technology, often in the form of a device that includes sensors placed on the skin above the target muscles. During the exercise, the NIRS device continuously measures the levels of oxygenated and deoxygenated hemoglobin in the muscles. The measures will be expressed in %.
Measured: Pre intervention and post intervention
Functional mobility
It will be assessed using the Timed Up and Go Test (TUG). The Time Up and Go (TUG) test is a widely used clinical assessment to evaluate mobility, functional mobility, and fall risk in individuals, particularly the elderly:
Procedure:
The individual starts by sitting in a standard armchair or chair with a backrest.
Upon the command "Go," the person stands up from the chair. The individual walks a distance of 3 meters (about 10 feet) as quickly and safely as possible.
Once they reach a marker or a designated spot, they turn around. The person walks back to the chair and sits down.
The measures will be expressed in seconds.
Measured: Pre intervention and post intervention
Respiratory muscle strength
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.
Procedure:
Preparation: The individual undergoing the test will be instructed on the procedure. They may sit or stand comfortably during the assessment.
Mouthpiece Placement: The individual will be asked to place the mouthpiece securely in their mouth, ensuring a tight seal to prevent air leakage.
Respiratory Maneuvers:
Maximum Inspiratory Pressure (MIP): 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.
Measured: Pre intervention and post intervention
Diaphragmatic thickness and thickening fraction
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.
Measured: Pre intervention and post intervention
Functional capacity
It will be assessed using the Five sit to Stand Test (5STS). It is a functional capacity assessment that measures an individual's ability to transition from a seated to a standing position.he individual starts in a seated position on a chair with a standardized height (typically armless and around knee height).
The feet are flat on the floor, shoulder-width apart.On the command to start, the person stands up from the chair completely and then returns to the seated position. This process is repeated four more times, making a total of five sit-to-stand transitions.
The measures will be expressed in seconds.
Measured: Pre intervention and post intervention
Diaphragm movement curve
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.
Measured: Pre intervention and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start14 Feb 2024 (estimated)
- Primary completion19 Feb 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Varona SL
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Sponsor
- Investigators
- arturo ladriñan, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266013
- Sponsor's protocol ID
- 009
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ladrinan-Maestro A, Sanchez-Infante J, Martin-Vera D, Sanchez-Sierra A. Influence of an inspiratory muscle fatigue protocol on older adults on respiratory muscle strength, muscle oxygen saturation, and functional capacity: a randomized controlled trial. BMC Geriatr. 2024 Dec 19;24(1):1015. doi: 10.1186/s12877-024-05610-0.
PubMed 39702081
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity
- ClinicalTrials.gov ID
- NCT06266013
- Acronym / sponsor ID
- 009
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sierra Varona SLUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- 14 Feb 2024 (estimated)
- Primary completion
- 19 Feb 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: inspiratory muscle trainingThe 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. |
| 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) |
| activation group | Active comparator | Other: inspiratory muscle trainingThe 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. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Being over 60 years old.
Key exclusion criteria (5 listed)
- Having any pathology that prevents the performance of physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingAlso: inspiratory muscle fatigueThe 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. | Other | activation group, intervention group |
Primary outcome
Muscle oxygen saturation (SmO2)
Time frame: Pre intervention and post intervention
is a physiological assessment that measures the saturation level of oxygen in muscles during exercise. it utilizes near-infrared spectroscopy (NIRS) technology, often in the form of a device that includes sensors placed on the skin above the target muscles. During the exercise, the NIRS device continuously measures the levels of oxygenated and deoxygenated hemoglobin in the muscles. The measures will be expressed in %.
Functional mobility
Time frame: Pre intervention and post intervention
It will be assessed using the Timed Up and Go Test (TUG). The Time Up and Go (TUG) test is a widely used clinical assessment to evaluate mobility, functional mobility, and fall risk in individuals, particularly the elderly: Procedure: The individual starts by sitting in a standard armchair or chair with a backrest. Upon the command "Go," the person stands up from the chair. The individual walks a distance of 3 meters (about 10 feet) as quickly and safely as possible. Once they reach a marker or a designated spot, they turn around. The person walks back to the chair and sits down. The measures will be expressed in seconds.
Respiratory muscle strength
Time frame: Pre intervention and 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. Procedure: Preparation: The individual undergoing the test will be instructed on the procedure. They may sit or stand comfortably during the assessment. Mouthpiece Placement: The individual will be asked to place the mouthpiece securely in their mouth, ensuring a tight seal to prevent air leakage. Respiratory Maneuvers: Maximum Inspiratory Pressure (MIP): 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
Time frame: Pre intervention and 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.
Functional capacity
Time frame: Pre intervention and post intervention
It will be assessed using the Five sit to Stand Test (5STS). It is a functional capacity assessment that measures an individual's ability to transition from a seated to a standing position.he individual starts in a seated position on a chair with a standardized height (typically armless and around knee height). The feet are flat on the floor, shoulder-width apart.On the command to start, the person stands up from the chair completely and then returns to the seated position. This process is repeated four more times, making a total of five sit-to-stand transitions. The measures will be expressed in seconds.
Diaphragm movement curve
Time frame: Pre intervention and 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39702081Ladrinan-Maestro A, Sanchez-Infante J, Martin-Vera D, Sanchez-Sierra A. Influence of an inspiratory muscle fatigue protocol on older adults on respiratory muscle strength, muscle oxygen saturation, and functional capacity: a randomized controlled trial. BMC Geriatr. 2024 Dec 19;24(1):1015. doi: 10.1186/s12877-024-05610-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
arturo ladriñan principal investigator
Universidad Europea de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Healthy, run by Sierra Varona SL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SIerra V SL (609956893, albertosanchezsierra77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle oxygen saturation (SmO2) (time frame: Pre intervention and post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.