Short Term Effects of Early Respiratory Muscle Training on Respiratory Muscle Strength in Inpatient Acute Stroke
August 13, 2026 updated by: Oktavianus Marciano, Prof. R. D. Kandou General Hospital
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:
- 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 Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Sulawesi
-
Manado, North Sulawesi, Indonesia
- Prof. R. D. Kandou General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
High-Intensity Interval Inspiratory and Expiratory Muscle Training
|
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.
|
|
Active Comparator: Control Group
Conventional Diaphragmatic Breathing Exercise
|
Diaphragmatic Breathing Exercise for 15 minutes in a semi-Fowler position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Day 3
|
|
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.
|
Baseline and Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoracic Expansion
Time Frame: Baseline and Day 3
|
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.
|
Baseline and Day 3
|
|
Single-Breath Counting Test (SBCT) Score
Time Frame: Baseline and Day 3
|
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.
|
Baseline and Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2026
Primary Completion (Estimated)
September 5, 2026
Study Completion (Estimated)
September 5, 2026
Study Registration Dates
First Submitted
August 13, 2026
First Submitted That Met QC Criteria
August 13, 2026
First Posted (Actual)
August 18, 2026
Study Record Updates
Last Update Posted (Actual)
August 18, 2026
Last Update Submitted That Met QC Criteria
August 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 089/EA/KEPK-KANDOU/II/2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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