Frailty SyndromeIMT-1NCT07258615
Longitudinal Ultrasound Assessment of Diaphragmatic and Respiratory Muscle Function Following Respiratory Muscle Training in Frail Older Adults
A study testing Inspiratory Muscle Training in people with Frailty Syndrome and Respiratory Muscle Weakness, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
This study aims to evaluate the effects of an 8-week inspiratory muscle training program on diaphragmatic and respiratory muscle function in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, impaired respiratory performance, and a higher risk of disability. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Frailty Syndrome, Respiratory Muscle Weakness, Age-Related Frailty
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2026to 31 Jul 2026
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults aged 80 years or older.
- Clinical diagnosis of frailty, defined by a Short Physical Performance Battery (SPPB) score < 9.
- Ability to stand and walk with or without assistive devices.
- Ability to understand and follow instructions for inspiratory muscle training.
- Stable medical condition for at least 3 months prior to enrollment.
- Capacity to provide informed consent or availability of a legal representative.
Who cannot join
- Acute or unstable cardiovascular, respiratory, or metabolic conditions.
- Severe cognitive impairment that prevents understanding the procedures.
- Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).
- Severe or uncontrolled hypertension (≥180/110 mmHg).
- Recent thoracic or abdominal surgery (<3 months).
- Severe musculoskeletal disorders limiting participation in training.
- History of recurrent syncope, severe dizziness, or intolerance to respiratory maneuvers.
- Any condition judged by the research team to compromise safety or participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Ultrasound Assessment of Diaphragmatic and Respiratory Muscle Function Following Respiratory Muscle Training in Frail Older Adults: A Randomized, Double-Blind, Sham-Controlled Trial
This study aims to evaluate the effects of an 8-week inspiratory muscle training program on diaphragmatic and respiratory muscle function in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, strength, and overall health in very old adults, but evidence in this age group remains limited.
Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety.
Read more
The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), an established measure of global inspiratory muscle strength. Secondary outcomes include ultrasound-based assessments of diaphragmatic structure and function, such as diaphragm thickness, contractile fraction, diaphragmatic excursion, inspiratory time, and inspiratory velocity during deep breathing and sniff maneuvers. These measurements will help clarify the physiological adaptations produced by inspiratory muscle training in this population.
Assessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, supporting its potential implementation in rehabilitation and geriatric care.
- Being tested
- Inspiratory Muscle Training, Sham Inspiratory Muscle Training
- Keywords
- Inspiratory Muscle Training, Diaphragm Ultrasound, Older Adults
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
Participants perform 30 breaths once daily, 5 days per week for 8 weeks using a threshold inspiratory muscle training device. The load begins at 50% of maximal inspiratory pressure (MIP) and increases by 5 cmH₂O weekly up to 80% of MIP. Sessions are supervised and oxygen saturation and heart rate are monitored.
Sham Inspiratory Muscle TrainingDevice
Participants use the same device and schedule as the experimental group (30 breaths once daily, 5 days per week for 8 weeks) but with a constant load of 15% of maximal inspiratory pressure (MIP), with no weekly progression. This mimics the procedure while providing minimal physiological stimulus. Supervision and monitoring are identical to the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Participants perform an 8-week inspiratory muscle training program using a threshold device (PowerBreathe). Training consists of 30 inspirations, once daily, 5 days per week. The initial load is set at 50% of each participant's maximal inspiratory pressure (MIP) and is increased weekly by 5 cmH₂O up to 80% of MIP. All sessions are supervised by healthcare professionals, with continuous monitoring of oxygen saturation and heart rate. Receives: Device: Inspiratory Muscle Training |
| Inspiratory Muscle Training (Sham) | Sham comparator | Participants follow the same 8-week training schedule using the threshold device (PowerBreathe), but with a constant load of 15% of maximal inspiratory pressure (MIP) and no weekly progression. Training consists of 30 inspirations, once daily, 5 days per week. The procedure mimics the experimental intervention but provides minimal physiological stimulus. All sessions are supervised, with monitoring of oxygen saturation and heart rate. Receives: Device: Sham Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure (MIP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal inspiratory effort from residual volume through the mouthpiece with their nose occluded. At least three maneuvers will be recorded, ensuring less than 10% variability between attempts. The highest reproducible value (cmH₂O) will be used for analysis. This measure reflects global inspiratory muscle strength and is widely validated in older and frail populations.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Secondary outcomes (9)
Diaphragm Thickness at End-Expiration (DTE)
Diaphragm thickness at end-expiration will be measured using 2D ultrasound at the zone of apposition. Three measurements will be obtained and averaged. This variable reflects diaphragm muscle thickness at rest.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragm Thickness at End-Inspiration (DTi)
Diaphragm thickness at end-inspiration will be measured using 2D ultrasound during a maximal inspiratory effort. Three measurements will be averaged. This variable reflects diaphragm contraction thickness.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragm Thickening Fraction (DTF)
The diaphragm thickening fraction will be calculated as:
Diaphragm Thickening Fraction (DTF) = [(Diaphragm Thickness at End-Inspiration (DTi) - Diaphragm Thickness at End-Expiration (DTE)) / DTE] × 100.
This percentage reflects diaphragm contractile capacity.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragmatic Excursion During Deep Breathing (DMDB)
Diaphragmatic excursion during deep breathing will be assessed with M-mode ultrasound during a maximal inspiratory maneuver. The average of three reproducible measurements will be used to quantify the cranio-caudal diaphragm displacement.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Time During Deep Breathing (DTDB)
Inspiratory time during deep breathing will be measured from the M-mode tracing as the time from the onset of diaphragm movement to its maximal excursion. This reflects the temporal characteristics of deep inspiration.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Velocity During Deep Breathing (DVDB)
Inspiratory velocity will be calculated by dividing diaphragmatic excursion (DMDB) by inspiratory time (DTDB), providing an estimate of average inspiratory velocity.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragmatic Excursion During Sniff Maneuver (DMVS)
Diaphragmatic excursion during a voluntary sniff will be measured with M-mode ultrasound during a rapid, forced nasal inspiration. The average of three reproducible efforts will be used to quantify rapid diaphragm displacement.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Time During Sniff Maneuver (DTVS)
Inspiratory time during the sniff maneuver will be measured from the start of diaphragm movement to its peak excursion on the M-mode tracing.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Velocity During Sniff Maneuver (DVVS)
Inspiratory velocity during sniff will be calculated by dividing sniff excursion by the corresponding inspiratory time, reflecting rapid contractile performance.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start12 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Sánchez-Infante, PhD, PT, Principal investigator, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258615
- Sponsor's protocol ID
- UFV-IMT1
- Acronym
- IMT-1
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, it is unclear whether individual participant data (IPD) will be shared. Data sharing will depend on institutional policies, ethical approvals, participant privacy considerations, and the feasibility of preparing de-identified datasets. A final decision will be made once data collection and analysis are completed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Ultrasound Assessment of Diaphragmatic and Respiratory Muscle Function Following Respiratory Muscle Training in Frail Older Adults: A Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07258615
- Acronym / sponsor ID
- IMT-1 / UFV-IMT1
- Keywords
- Inspiratory Muscle Training, Diaphragm Ultrasound, Older Adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 Dec 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.
This study aims to evaluate the effects of an 8-week inspiratory muscle training program on diaphragmatic and respiratory muscle function in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, strength, and overall health in very old adults, but evidence in this age group remains limited.
Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety.
The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), an established measure of global inspiratory muscle strength. Secondary outcomes include ultrasound-based assessments of diaphragmatic structure and function, such as diaphragm thickness, contractile fraction, diaphragmatic excursion, inspiratory time, and inspiratory velocity during deep breathing and sniff maneuvers. These measurements will help clarify the physiological adaptations produced by inspiratory muscle training in this population.
Assessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, supporting its potential implementation in rehabilitation and geriatric care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Device: Inspiratory Muscle TrainingParticipants perform an 8-week inspiratory muscle training program using a threshold device (PowerBreathe). Training consists of 30 inspirations, once daily, 5 days per week. The initial load is set at 50% of each participant's maximal inspiratory pressure (MIP) and is increased weekly by 5 cmH₂O up to 80% of MIP. All sessions are supervised by healthcare professionals, with continuous monitoring of oxygen saturation and heart rate. |
| Inspiratory Muscle Training (Sham) | Sham comparator | Device: Sham Inspiratory Muscle TrainingParticipants follow the same 8-week training schedule using the threshold device (PowerBreathe), but with a constant load of 15% of maximal inspiratory pressure (MIP) and no weekly progression. Training consists of 30 inspirations, once daily, 5 days per week. The procedure mimics the experimental intervention but provides minimal physiological stimulus. All sessions are supervised, with monitoring of oxygen saturation and heart rate. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Adults aged 80 years or older.
- Clinical diagnosis of frailty, defined by a Short Physical Performance Battery (SPPB) score < 9.
- Ability to stand and walk with or without assistive devices.
- Ability to understand and follow instructions for inspiratory muscle training.
- Stable medical condition for at least 3 months prior to enrollment.
Key exclusion criteria (8 listed)
- Acute or unstable cardiovascular, respiratory, or metabolic conditions.
- Severe cognitive impairment that prevents understanding the procedures.
- Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).
- Severe or uncontrolled hypertension (≥180/110 mmHg).
- Recent thoracic or abdominal surgery (<3 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 TrainingParticipants perform 30 breaths once daily, 5 days per week for 8 weeks using a threshold inspiratory muscle training device. The load begins at 50% of maximal inspiratory pressure (MIP) and increases by 5 cmH₂O weekly up to 80% of MIP. Sessions are supervised and oxygen saturation and heart rate are monitored. | Device | Inspiratory Muscle Training |
| Sham Inspiratory Muscle TrainingParticipants use the same device and schedule as the experimental group (30 breaths once daily, 5 days per week for 8 weeks) but with a constant load of 15% of maximal inspiratory pressure (MIP), with no weekly progression. This mimics the procedure while providing minimal physiological stimulus. Supervision and monitoring are identical to the experimental arm. | Device | Inspiratory Muscle Training (Sham) |
Primary outcome
Maximal Inspiratory Pressure (MIP)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Maximal Inspiratory Pressure (MIP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal inspiratory effort from residual volume through the mouthpiece with their nose occluded. At least three maneuvers will be recorded, ensuring less than 10% variability between attempts. The highest reproducible value (cmH₂O) will be used for analysis. This measure reflects global inspiratory muscle strength and is widely validated in older and frail populations.
9 secondary outcomes
Diaphragm Thickness at End-Expiration (DTE)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragm Thickness at End-Inspiration (DTi)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragm Thickening Fraction (DTF)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragmatic Excursion During Deep Breathing (DMDB)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Time During Deep Breathing (DTDB)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Velocity During Deep Breathing (DVDB)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Diaphragmatic Excursion During Sniff Maneuver (DMVS)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Time During Sniff Maneuver (DTVS)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Inspiratory Velocity During Sniff Maneuver (DVVS)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months 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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. At this time, it is unclear whether individual participant data (IPD) will be shared. Data sharing will depend on institutional policies, ethical approvals, participant privacy considerations, and the feasibility of preparing de-identified datasets. A final decision will be made once data collection and analysis are completed.
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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.
Jorge Sánchez-Infante, PhD, PT principal investigator
Universidad Francisco de Vitoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Frailty Syndrome and Respiratory Muscle Weakness, run by Universidad Francisco de Vitoria at 1 site in Spain.
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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (MIP) (time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention). 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 27 Feb 2026.