Short Term Effects of Early Respiratory Muscle Training on Respiratory Muscle Strength in Inpatient Acute Stroke
13 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Sulawesi
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Manado, North Sulawesi, Indonesien
- Prof. R. D. Kandou General Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention Group
High-Intensity Interval Inspiratory and Expiratory Muscle Training
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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.
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Aktiv komparator: Control Group
Conventional Diaphragmatic Breathing Exercise
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Diaphragmatic Breathing Exercise for 15 minutes in a semi-Fowler position.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximal Inspiratory Pressure
Tidsram: 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.
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Baseline and Day 3
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Maximal Expiratory Pressure
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Thoracic Expansion
Tidsram: 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.
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Baseline and Day 3
|
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Single-Breath Counting Test (SBCT) Score
Tidsram: 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.
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Baseline and Day 3
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Samarbetspartners och utredare
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Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2026
Primärt slutförande (Beräknad)
5 september 2026
Avslutad studie (Beräknad)
5 september 2026
Studieregistreringsdatum
Först inskickad
13 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
13 augusti 2026
Första postat (Faktisk)
18 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2026
Senast verifierad
1 mars 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 089/EA/KEPK-KANDOU/II/2026
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