Air Stacking-Assisted Diaphragmatic Breathing in Stroke

NCT07577076 | Completed

• 1 other identifier: 2025-05-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether a diaphragmatic breathing exercise using the air stacking technique can improve respiratory function and trunk control in patients with stroke. The experimental group will perform an air stacking-based diaphragmatic breathing exercise using an Ambu-bag, combined with neurodevelopmental treatment, three times per week for 20 minutes over a 4-week period. The control group will receive therapist-guided diaphragmatic breathing exercises with the same frequency and duration, together with the same neurodevelopmental treatment. All participants will be assessed before and after the intervention for pulmonary function, chest wall expansion, and trunk control ability, as well as the Korean version of the Trunk Impairment Scale (K-TIS), the Five Times Sit-to-Stand Test (FTSTS), and the Borg Rating of Perceived Exertion (Borg RPE). Changes between the two groups will be compared to determine the therapeutic effectiveness of the air stacking technique.

Conditions

Stroke; Hemiplegia

Keywords

Stroke; Hemiplegia; Respiratory rehabilitation; Diaphragmatic breathing; Air stacking; Ambu-bag; Pulmonary function; Trunk Impairment Scale

Outcome Measures

Primary Outcomes (4)

• Change in Forced Vital Capacity (FVC)

  Forced vital capacity (FVC) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in FVC from baseline to 4 weeks in each group.

  Baseline and 4 weeks after the start of intervention

• Change in Forced Expiratory Volume in 1 Second (FEV1)

  Forced expiratory volume in 1 second (FEV1) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in FEV1 from baseline to 4 weeks in each group.

  Baseline and 4 weeks after the start of intervention

• Change in FEV1/FVC ratio

  The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in FEV1/FVC from baseline to 4 weeks in each group.

  Baseline and 4 weeks after the start of intervention

• Change in Peak Expiratory Flow (PEF)

  Peak expiratory flow (PEF) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in PEF from baseline to 4 weeks in each group.

  Baseline and 4 weeks after the start of intervention

Secondary Outcomes (3)

• Change in Trunk Function (Korean Version of the Trunk Impairment Scale, K-TIS)

  Baseline and 4 weeks after the start of intervention

• Change in Functional Lower Extremity Performance (Five Times Sit-to-Stand Test, FTSTS)

  Baseline and 4 weeks after the start of intervention

• Change in Perceived Exertion (Borg Rating of Perceived Exertion Scale)

  Baseline and 4 weeks after the start of intervention

Study Arms (2)

Air stacking-assisted diaphragmatic breathing

EXPERIMENTAL

articipants in this arm will receive diaphragmatic breathing exercises using the air stacking technique with an Ambu-bag three times per week for 20 minutes over 4 weeks, in addition to routine neurodevelopmental treatment.

Behavioral: Air stacking-assisted diaphragmatic breathing

diaphragmatic breathing

ACTIVE COMPARATOR

Participants in this arm will receive diaphragmatic breathing exercises three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental group.

Behavioral: diaphragmatic breathing

Interventions

diaphragmatic breathing BEHAVIORAL

diaphragmatic breathing exercise performed three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental group.

diaphragmatic breathing

Air stacking-assisted diaphragmatic breathing BEHAVIORAL

Diaphragmatic breathing exercise using the air stacking technique with an Ambu-bag, performed three times per week for 20 minutes over 4 weeks, in addition to routine neurodevelopmental treatment.

Air stacking-assisted diaphragmatic breathing

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients diagnosed with stroke (intracerebral hemorrhage or cerebral infarction) at a general hospital in Daegu, currently receiving physical therapy
• Onset of stroke at least 3 months prior to enrollment
• Spasticity grade of 2 or less on the Modified Ashworth Scale
• No congenital deformity or fracture of the thorax or other orthopedic conditions affecting the chest wall
• No history of pulmonary disease before or after the stroke
• Able to perform respiratory exercises as instructed
• Mini-Mental State Examination-Korean version (MMSE-K) score of 24 or higher, indicating sufficient cognitive ability to understand the study procedures
• Presence of decreased pulmonary function (reduced pulmonary function test parameters) at baseline

You may not qualify if:

• Acute stroke status or onset of stroke less than 3 months prior to enrollment
• Severe cardiovascular or respiratory disease that makes participation in respiratory exercise unsafe or impossible
• Cognitive impairment or communication disorder that prevents understanding or performing the study procedures
• Any other medical or safety condition judged by the investigator to make participation in the study inappropriate

Sponsors & Collaborators

• jang ji-hun: lead

Study Sites (1)

Daegu Fatima Hospital

Daegu, Daegu, 41199, South Korea

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by a physical therapist who is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist, Principal Investigator

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 11, 2026
• Study Start: September 25, 2025
• Primary Completion: February 21, 2026
• Study Completion: February 21, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

KR (1)