Frailty SyndromeNCT07556445
Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults (IMT-3)
A study testing Inspiratory Muscle Training in people with Frailty Syndrome and Geriatric Health, run by Universidad Francisco de Vitoria.
Trial summary
This study aims to evaluate the effects of an 8-week inspiratory muscle training program on lung function and respiratory muscle strength in frail older adults aged 80 years and above. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty Syndrome, Geriatric Health, Respiratory Muscle Weakness
- 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
- No sites listed yet
- Study dates
- 20 May 2026to 1 Dec 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
- Healthy volunteers accepted
- 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
Who cannot join
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles 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 lung function and respiratory muscle strength in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle 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), maximal expiratory pressure (MEP) and lung function. These outcomes will allow the evaluation of the clinical relevance of improvements in respiratory muscle strength 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, particularly its impact on respiratory muscle strength and lung function, supporting its potential implementation in rehabilitation and geriatric care.
- Being tested
- Inspiratory Muscle Training, Sham Inspiratory Muscle Training
- Keywords
- Inspiratory Muscle Training, Older Adults, Lung Function, Respiratory Muscle Strength
- 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
Inspiratory Muscle Training 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 cmH#O weekly up to 80% of MIP. Sessions are supervised and oxygen saturation and heart rate are monitored.
Sham Inspiratory Muscle TrainingDevice
Sham Inspiratory Muscle Training 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 | Inspiratory Muscle Training 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 cmH#O up to 80% of MIP. All sessions are supervised by healthcare professionals, with continuous monitoring of oxygen saturation and heart rateExperi Receives: Device: Inspiratory Muscle Training |
| Inspiratory Muscle Training (Sham) | Sham comparator | Inspiratory Muscle Training (Sham) 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
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure (MEP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal expiratory 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
Forced Vital Capacity
Forced Vital Capacity (FVC) is the maximum volume of air, expressed in milliliters, that the subject is able to inhale during a forced inspiration, which will be measured using spirometry.
Measured: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Forced Expiratory Volume in the First Second (FEV1)
Forced Expiratory Volume in the First Second (FEV1) is the maximum volume of air exhaled in the first second, measured in milliliters, which provides information on lung elasticity and will be measured using spirometry.
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 posted29 Apr 2026
- Study start20 May 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556445
- Sponsor's protocol ID
- UFV-IMT3
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 30 Apr 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults: A Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07556445
- Acronym / sponsor ID
- UFV-IMT3
- Keywords
- Inspiratory Muscle Training, Older Adults, Lung Function, Respiratory Muscle Strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Apr 2026 (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 lung function and respiratory muscle strength in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle 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), maximal expiratory pressure (MEP) and lung function. These outcomes will allow the evaluation of the clinical relevance of improvements in respiratory muscle strength 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, particularly its impact on respiratory muscle strength and lung function, 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 TrainingInspiratory Muscle Training 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 cmH#O up to 80% of MIP. All sessions are supervised by healthcare professionals, with continuous monitoring of oxygen saturation and heart rateExperi |
| Inspiratory Muscle Training (Sham) | Sham comparator | Device: Sham Inspiratory Muscle TrainingInspiratory Muscle Training (Sham) 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 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 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.
Key exclusion criteria (7 listed)
- 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.
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 TrainingInspiratory Muscle Training 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 cmH#O weekly up to 80% of MIP. Sessions are supervised and oxygen saturation and heart rate are monitored. | Device | Inspiratory Muscle Training |
| Sham Inspiratory Muscle TrainingSham Inspiratory Muscle Training 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. | 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.
Maximal Expiratory Pressure (MEP)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Maximal Expiratory Pressure (MEP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal expiratory 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.
Forced Vital Capacity
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Forced Vital Capacity (FVC) is the maximum volume of air, expressed in milliliters, that the subject is able to inhale during a forced inspiration, which will be measured using spirometry.
Forced Expiratory Volume in the First Second (FEV1)
Time frame: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Forced Expiratory Volume in the First Second (FEV1) is the maximum volume of air exhaled in the first second, measured in milliliters, which provides information on lung elasticity and will be measured using spirometry.
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 30 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Frailty Syndrome and Geriatric Health, run by Universidad Francisco de Vitoria.
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 7 inclusion and 7 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 30 Apr 2026. 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. 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?
Contact Michelle Matos Duarte, PhD (+34 913 24 80 64, michelle.matos@ufv.es), or a site near the patient. 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). The study lists 4 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 30 Apr 2026.