Acute Stroke, Expiratory Muscle Training, Inspiratory Muscle Strength, Inspiratory Muscle Training, Respiratory Muscle Strength, Respiratory Muscle Training, Stroke
Conditions
Keywords
Stroke, Breathing Exercises, Respiratory Muscles, Muscle Strength, Stroke Rehabilitation
Brief 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 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.
Interventions
BEHAVIORALHigh-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.
BEHAVIORALControl Group
Diaphragmatic Breathing Exercise for 15 minutes in a semi-Fowler position.
Sponsors
Prof. R. D. Kandou General Hospital
Sam Ratulangi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Inspiratory Pressure | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thoracic Expansion | 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. |
| Single-Breath Counting Test (SBCT) Score | 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. |
Countries
Indonesia
Outcome results
None listed