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NCT Number: NCT07770776

Short Term Effects of Early Respiratory Muscle Training on Respiratory Muscle Strength in Inpatient 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Expiratory Muscle Training Inspiratory Muscle Strength Inspiratory Muscle Training Nervous System Diseases Respiratory Muscle Strength Respiratory Muscle Training Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. R. D. Kandou General Hospital

Manado, North Sulawesi, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT)

Behavioral

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 Group

Behavioral

Diaphragmatic Breathing Exercise for 15 minutes in a semi-Fowler position.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Prof. R. D. Kandou General Hospital

Other

Collaborators

  • Sam Ratulangi University

Registry information

Official study title

Short-Term Effects of Early Combined High-Intensity Interval Inspiratory and Expiratory Muscle Training on Respiratory Muscle Strength in Inpatients With Acute Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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