Short-Term Effects of Early Combined High-Intensity Interval Inspiratory and Expiratory Muscle Training on Respiratory Muscle Strength in Inpatients With Acute Stroke
| Registry | NCT07770776 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 24 (Actual) |
| Sponsor | Prof. R. D. Kandou General Hospital (Other); collaborators: Sam Ratulangi University |
| Conditions | Stroke, Acute Stroke, Respiratory Muscle Strength, Respiratory Muscle Training, Inspiratory Muscle Strength, Inspiratory Muscle Training, Expiratory Muscle Training |
| Interventions | High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT), Control Group (Behavioral) |
| Dates | start 2026-04-01, primary completion 2026-09-05 (estimated), completion 2026-09-05 (estimated), first posted 2026-08-18, last updated 2026-08-18 |
| Locations | 1 site in Indonesia |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials for Acute Stroke All trials of High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT) All trials of Control Group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 Group | Conventional Diaphragmatic Breathing Exercise |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Prof. R. D. Kandou General Hospital | Manado, North Sulawesi | Indonesia |