StrokeNCT07770776
Short Term Effects of Early Respiratory Muscle Training on Respiratory Muscle Strength in Inpatient Acute Stroke
A study testing High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT) in people with Stroke and Acute Stroke, run by Prof. R. D. Kandou General Hospital at 1 site in Indonesia.
Trial summary
This study aims to determine the early effectiveness of combined high-intensity interval inspiratory and expiratory muscle training in hospitalized patients with acute stroke. Participants will be assigned to receive either combined high-intensity interval inspiratory and expiratory muscle training or conventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Stroke, Respiratory Muscle Strength
- What is being tested?
- High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2026to 5 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 years or older.
- First-ever acute ischemic stroke, with stroke onset 2 to 14 days before enrollment, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).
- National Institutes of Health Stroke Scale (NIHSS) score ≥5, with the presence of hemiparesis.
- Baseline maximal inspiratory pressure (MIP) <80 cmH₂O.
- Baseline maximal expiratory pressure (MEP) <68 cmH₂O.
- Able to understand instructions and participate in the respiratory muscle training program.
- Willing to comply with the study protocol and provide written informed consent.
Who cannot join
- Resting blood pressure >160/100 mmHg.
- Resting peripheral oxygen saturation (SpO₂) <92%.
- Resting heart rate <40 beats/min or >110 beats/min.
- Fever, defined as body temperature ≥37.5°C.
- Previous participation in or experience with a respiratory muscle training program.
- Presence of chronic pulmonary disease.
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- Presence of a tracheostomy tube.
- Presence of unstable cardiac disease.
- Presence of another neurological disorder associated with respiratory dysfunction.
- Presence of an orthopedic or musculoskeletal condition that significantly interferes with respiratory function or the ability to perform respiratory muscle training.
- History of major thoracic or abdominal surgery within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Effects of Early Combined High-Intensity Interval Inspiratory and Expiratory Muscle Training on Respiratory Muscle Strength in Inpatients With Acute Stroke
This study aims to determine the early effectiveness of combined high-intensity interval inspiratory and expiratory muscle training in hospitalized patients with acute stroke. Participants will be assigned to receive either combined high-intensity interval inspiratory and expiratory muscle training or conventional diaphragmatic breathing exercises.
The main questions this study aims to answer are whether the combined high-intensity interval inspiratory and expiratory muscle training can improve:
Read more
- inspiratory muscle strength, measured using maximal inspiratory pressure;
- expiratory muscle strength, measured using maximal expiratory pressure;
- chest expansion, measured using thoracic expansion; and
- the ability to sustain speech on a single breath, measured using the single-breath count test.
Researchers will compare changes before and after the intervention between the two groups to determine whether combined high-intensity interval inspiratory and expiratory muscle training provides greater early improvement than conventional diaphragmatic breathing exercises in hospitalized patients with acute stroke.
- Conditions
- Stroke, Acute Stroke, Respiratory Muscle Strength, Respiratory Muscle Training, Inspiratory Muscle Strength, Inspiratory Muscle Training
- Being tested
- High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT), Control Group
- Keywords
- Stroke, Breathing Exercises, Respiratory Muscles, Muscle Strength, Stroke Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT)Behavioural
High-intensity interval inspiratory and expiratory muscle training is performed using the BigBreathe Double Action IMT/PEP device, which provides resistance during inspiration and expiration. Participants perform the exercise in a semi-Fowler position using a mouthpiece with an airtight lip seal. Training is performed once daily for 5 consecutive days, with five 2-minute sets per session and approximately 1 minute of rest between sets. Inspiratory resistance is set at 50% of MIP and expiratory resistance at 30% of MEP.
Control GroupBehavioural
Diaphragmatic Breathing Exercise for 15 minutes in a semi-Fowler position.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | High-Intensity Interval Inspiratory and Expiratory Muscle Training Receives: Behavioral: High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT) |
| Control Group | Active comparator | Conventional Diaphragmatic Breathing Exercise Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
Maximal inspiratory pressure (MIP) is used to assess inspiratory muscle strength. Participants perform a maximal inspiratory effort against an occluded airway starting from residual volume. MIP is recorded in centimeters of water (cmH₂O). A greater magnitude of MIP indicates greater inspiratory muscle strength.
Measured: Baseline and Day 3
Maximal Expiratory Pressure
Maximal expiratory pressure (MEP) is used to assess expiratory muscle strength. Participants perform a maximal expiratory effort against an occluded airway. MEP is recorded in centimeters of water (cmH₂O). Higher MEP values indicate greater expiratory muscle strength.
Measured: Baseline and Day 3
Secondary outcomes (2)
Thoracic Expansion
Thoracic expansion is assessed as the difference in chest circumference between maximal inhalation and maximal exhalation. Chest circumference is measured using a measuring tape at a standardized thoracic level and is reported in centimeters (cm). A greater difference indicates greater chest wall expansion.
Measured: Baseline and Day 3
Single-Breath Counting Test (SBCT) Score
The Single-Breath Counting Test (SBCT) is a bedside assessment of respiratory function. After a maximal inspiration, participants count aloud sequentially for as long as possible during a single exhalation. The highest number reached during one breath is recorded as the SBCT score. A higher score indicates a greater ability to sustain phonation during a single breath.
Measured: Baseline and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Apr 2026
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. R. D. Kandou General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sam Ratulangi University
- Responsible party
- Principal investigator, Oktavianus Marciano, Prof. R. D. Kandou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770776
- Sponsor's protocol ID
- 089/EA/KEPK-KANDOU/II/2026
- Status last verified
- Mar 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Early Combined High-Intensity Interval Inspiratory and Expiratory Muscle Training on Respiratory Muscle Strength in Inpatients With Acute Stroke
- ClinicalTrials.gov ID
- NCT07770776
- Acronym / sponsor ID
- 089/EA/KEPK-KANDOU/II/2026
- Conditions
- Stroke, Acute Stroke, Respiratory Muscle Strength, Respiratory Muscle Training, Inspiratory Muscle Strength, Inspiratory Muscle Training
- Keywords
- Stroke, Breathing Exercises, Respiratory Muscles, Muscle Strength, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prof. R. D. Kandou General HospitalUniversity, hospital or other
- Collaborators
- Sam Ratulangi University
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Sep 2026 (estimated)
- First posted
- 18 Aug 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 determine the early effectiveness of combined high-intensity interval inspiratory and expiratory muscle training in hospitalized patients with acute stroke. Participants will be assigned to receive either combined high-intensity interval inspiratory and expiratory muscle training or conventional diaphragmatic breathing exercises.
The main questions this study aims to answer are whether the combined high-intensity interval inspiratory and expiratory muscle training can improve:
- inspiratory muscle strength, measured using maximal inspiratory pressure;
- expiratory muscle strength, measured using maximal expiratory pressure;
- chest expansion, measured using thoracic expansion; and
- the ability to sustain speech on a single breath, measured using the single-breath count test.
Researchers will compare changes before and after the intervention between the two groups to determine whether combined high-intensity interval inspiratory and expiratory muscle training provides greater early improvement than conventional diaphragmatic breathing exercises in hospitalized patients with acute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT)High-Intensity Interval Inspiratory and Expiratory Muscle Training |
| Control Group | Active comparator | Behavioral: Control GroupConventional Diaphragmatic Breathing Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged 18 years or older.
- First-ever acute ischemic stroke, with stroke onset 2 to 14 days before enrollment, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).
- National Institutes of Health Stroke Scale (NIHSS) score ≥5, with the presence of hemiparesis.
- Baseline maximal inspiratory pressure (MIP) <80 cmH₂O.
- Baseline maximal expiratory pressure (MEP) <68 cmH₂O.
Key exclusion criteria (11 listed)
- Resting blood pressure >160/100 mmHg.
- Resting peripheral oxygen saturation (SpO₂) <92%.
- Resting heart rate <40 beats/min or >110 beats/min.
- Fever, defined as body temperature ≥37.5°C.
- Previous participation in or experience with a respiratory muscle training program.
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 |
|---|---|---|
| High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT)High-intensity interval inspiratory and expiratory muscle training is performed using the BigBreathe Double Action IMT/PEP device, which provides resistance during inspiration and expiration. Participants perform the exercise in a semi-Fowler position using a mouthpiece with an airtight lip seal. Training is performed once daily for 5 consecutive days, with five 2-minute sets per session and approximately 1 minute of rest between sets. Inspiratory resistance is set at 50% of MIP and expiratory resistance at 30% of MEP. | Behavioural | Intervention Group |
| Control GroupDiaphragmatic Breathing Exercise for 15 minutes in a semi-Fowler position. | Behavioural | Control Group |
Primary outcome
Maximal Inspiratory Pressure
Time frame: Baseline and Day 3
Maximal inspiratory pressure (MIP) is used to assess inspiratory muscle strength. Participants perform a maximal inspiratory effort against an occluded airway starting from residual volume. MIP is recorded in centimeters of water (cmH₂O). A greater magnitude of MIP indicates greater inspiratory muscle strength.
Maximal Expiratory Pressure
Time frame: Baseline and Day 3
Maximal expiratory pressure (MEP) is used to assess expiratory muscle strength. Participants perform a maximal expiratory effort against an occluded airway. MEP is recorded in centimeters of water (cmH₂O). Higher MEP values indicate greater expiratory muscle strength.
2 secondary outcomes
Thoracic Expansion
Time frame: Baseline and Day 3
Single-Breath Counting Test (SBCT) Score
Time frame: Baseline and Day 3
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 18 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT) in people with Stroke and Acute Stroke, run by Prof. R. D. Kandou General Hospital at 1 site in Indonesia.
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 11 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 18 Aug 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 Indonesia. 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. 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 (time frame: Baseline and Day 3). The study lists 2 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 18 Aug 2026.