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

NCT07770776 | Active Not Recruiting DMC

• 1 other identifier: 089/EA/KEPK-KANDOU/II/2026
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stroke; Breathing Exercises; Respiratory Muscles; Muscle Strength; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Day 3

• 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.

  Baseline and Day 3

Secondary Outcomes (2)

• Thoracic Expansion

  Baseline and Day 3

• Single-Breath Counting Test (SBCT) Score

  Baseline and Day 3

Study Arms (2)

Intervention Group

EXPERIMENTAL

High-Intensity Interval Inspiratory and Expiratory Muscle Training

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

Control Group

ACTIVE COMPARATOR

Conventional Diaphragmatic Breathing Exercise

Behavioral: Control Group

Interventions

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.

Intervention Group

Control Group BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. R. D. Kandou General Hospital: lead
• Sam Ratulangi University: collaborator

Study Sites (1)

Prof. R. D. Kandou General Hospital

Manado, North Sulawesi, Indonesia

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: April 1, 2026
• Primary Completion: September 5, 2026
• Study Completion: September 5, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-03

Locations

ID (1)