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Active, not recruitingNCT07770776Updated Aug 18, 2026

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

An interventional study of High-Intensity Interval Inspiratory and Expiratory Muscle Training (H-IIIEMT) and Control Group in Stroke, Acute Stroke and Respiratory Muscle Strength, sponsored by Prof. R. D. Kandou General Hospital. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Prof. R. D. Kandou General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Acute Stroke
  • Respiratory Muscle Strength
  • Respiratory Muscle Training
  • Inspiratory Muscle Strength
  • Inspiratory Muscle Training
  • Expiratory Muscle Training

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Keywords

  • Stroke
  • Breathing Exercises
  • Respiratory Muscles
  • Muscle Strength
  • Stroke Rehabilitation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Intervention Group

    High-Intensity Interval Inspiratory and Expiratory Muscle Training

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

  • Active comparator
    Control Group

    Conventional Diaphragmatic Breathing Exercise

    Behavioral: Control Group

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.

05

What researchers measure

Primary outcomes

  1. Maximal Inspiratory Pressure

    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.

    Time frame: Baseline and Day 3

  2. Maximal Expiratory Pressure

    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.

    Time frame: Baseline and Day 3

Secondary outcomes

  1. Thoracic Expansion

    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.

    Time frame: Baseline and Day 3

  2. Single-Breath Counting Test (SBCT) Score

    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.

    Time frame: Baseline and Day 3

06

Study locations

1 site
  • Prof. R. D. Kandou General Hospital
    Manado, North Sulawesi, Indonesia
07

Registry details

Key details

Study ID
NCT07770776
Lead sponsor
Prof. R. D. Kandou General Hospital
Collaborators
Sam Ratulangi University
Responsible party
Oktavianus Marciano (MD, Prof. R. D. Kandou General Hospital) — Principal investigator
First posted
Aug 18, 2026
Start date
Apr 1, 2026
Primary completion
Sep 5, 2026 (estimated)
Completion
Sep 5, 2026 (estimated)
Last update
Aug 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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