SedentaryNCT06895304
Effects of Inspiratory Muscle Fatigue and Warm-up on Respiratory Variables, Handgrip Strength, and Walking Capacity in Sedentary Older Adults
A study testing inspiratory muscle training in people with Sedentary and 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 65 to 99 yearsHealthy volunteers can take part
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being over 60 years old.
- Physical independence in terms of gait and transfers
- Engaging in less than 150 minutes of physical activity per week.
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 chronic respiratory, cardiac, renal, or metabolic pathology..
- Subjects who have undergone lower limb surgery within the past 12 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Inspiratory Muscle Fatigue and Warm-up on Respiratory Variables, Handgrip Strength, and Walking Capacity in Sedentary Older Adults: A Randomized Clinical Trial.
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 or warm-up and muscular strength in upper and lower limbs, in sedentary older adults, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, diaphragmatic ultrasonography, functionality and handgrip strength.
According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue or activation in sedentary older adults could influence muscular strength, respiratory function and exercise capacity.
Read more
In this study, subjects will be divided into three groups: the fatigue group , the activation group and the control group.
Measurements of variables, such as maximal inspiratory pressure, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted.
Read the detailed description
This is a randomized control trial. The fatigue group (EG) will perform the 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. 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
Walking capacity will be assessed using the 6 minutes walking test (6MWT) 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 Handgrip strength will be assessed using a handgrip dynamometer. This will be done immediately before intervention and immediately after intervention.
- Being tested
- inspiratory muscle training
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingDevice
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 upper limbs.
inspiratory muscle trainingDevice
Also called Inspiratory muscle activation
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 upper limbs.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle fatigue group | Experimental | The EG (fatigue 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: Device: 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) |
| Inspiratory muscle 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: Device: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
It will be assessed using a MicroRPM® (MicroMedical, UK).
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: Immediately before intervention and immediately after 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: Immediately before intervention and immediately after 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 milliseconds.
Measured: Immediately before intervention and immediately after intervention
Secondary outcomes (2)
6 minutes walking test
The 6-Minute Walk Test (6MWT) is a functional cardiorespiratory assessment that measures the maximum distance a subject can walk in six minutes. The patient will be instructed to walk at the fastest possible pace along a 30-meter corridor. The therapist will accompany the patient throughout the test, and the use of assistive devices and/or external oxygen supplementation will be permitted if necessary.
The measures will be expressed in meters.
Measured: Immediately before intervention and immediately after intervention
Handgrip strength
The recommendations of the American Society of Hand Therapists will be followed: the subject will be positioned with the shoulder in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist positioned between 0° and 30° of extension.
Three maximum grip strength measurements will be performed on the dominant hand, with one-minute rest intervals between trials, selecting the highest value.
Handgrip strength dynamometry will be conducted using a JAMAR dynamometer (Lafayette Instrument, Lafayette, IN, USA).
The measures will be expressed in kilograms
Measured: Immediately before intervention and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion3 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedentaryStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Varona SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895304
- Sponsor's protocol ID
- 018
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Fatigue and Warm-up on Respiratory Variables, Handgrip Strength, and Walking Capacity in Sedentary Older Adults: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06895304
- Acronym / sponsor ID
- 018
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sierra Varona SLUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 26 Mar 2025 (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 inspiratory muscle fatigue or warm-up and muscular strength in upper and lower limbs, in sedentary older adults, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, diaphragmatic ultrasonography, functionality and handgrip strength.
According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue or activation in sedentary older adults could influence muscular strength, respiratory function and exercise capacity.
In this study, subjects will be divided into three groups: the fatigue group , the activation group and the control group.
Measurements of variables, such as maximal inspiratory pressure, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted.
Detailed description
This is a randomized control trial. The fatigue group (EG) will perform the 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. 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
Walking capacity will be assessed using the 6 minutes walking test (6MWT) 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 Handgrip strength will be assessed using a handgrip dynamometer. This will be done 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 |
|---|---|---|
| Inspiratory muscle fatigue group | Experimental | Device: inspiratory muscle trainingThe EG (fatigue 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) |
| Inspiratory muscle activation group | Active comparator | Device: 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
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being over 60 years old.
- Physical independence in terms of gait and transfers
- Engaging in less than 150 minutes of physical activity per week.
Key exclusion criteria (5 listed)
- 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 chronic respiratory, cardiac, renal, or metabolic pathology..
- Subjects who have undergone lower limb surgery within the past 12 months.
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 upper limbs. | Device | Inspiratory muscle fatigue group |
| inspiratory muscle trainingAlso: Inspiratory muscle activationThe subjects will perform deep inspirations against a threshold device with varying resistances to observe the effect on the diaphragm and the musculature of the upper limbs. | Device | Inspiratory muscle activation group |
Primary outcome
Respiratory muscle strength
Time frame: Immediately before intervention and immediately after intervention
It will be assessed using a MicroRPM® (MicroMedical, UK). 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: Immediately before intervention and immediately after 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.
Diaphragm movement curve
Time frame: Immediately before intervention and immediately after 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 milliseconds.
2 secondary outcomes
6 minutes walking test
Time frame: Immediately before intervention and immediately after intervention
Handgrip strength
Time frame: Immediately before intervention and immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Sedentary and 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 3 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: opening soon, as of the sponsor's last update on 26 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arturo Ladriñan (925 26 88 00, arturo.ladrinan@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: Immediately before intervention and immediately after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2025.