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Air Stacking-Assisted Diaphragmatic Breathing in Stroke

5. mai 2026 oppdatert av: jang ji-hun

Effects of Diaphragmatic Breathing Exercise Using the Air Stacking Technique on Respiratory and Trunk Function in Patients With Stroke: A Randomized Controlled Trial

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This clinical trial is a randomized controlled study designed to evaluate the effects of a diaphragmatic breathing exercise using the air stacking technique on respiratory and trunk function in patients with stroke. Patients with stroke are prone to respiratory muscle weakness, reduced chest wall expansion, and impaired trunk control, which can limit functional recovery and increase the risk of pulmonary complications. The air stacking technique increases lung volume and chest expansion through consecutive inspirations without exhalation and is known to facilitate more effective breathing and coughing, but its therapeutic effects in patients with stroke have not yet been fully established.

In this study, 20 patients with stroke will be randomly assigned to an experimental group (n = 10) or a control group (n = 10), using blocked randomization to ensure balance between groups. To enhance the objectivity of outcome assessment, all evaluations will be performed by an assessor who is blinded to group allocation. The experimental group will perform an air stacking-based diaphragmatic breathing exercise using an Ambu-bag, three times per week for 20 minutes over a 4-week period, in addition to neurodevelopmental treatment. The control group will receive therapist-guided diaphragmatic breathing exercises with the same frequency and duration, combined with the same neurodevelopmental treatment program. Both groups will receive the interventions for 4 weeks in the same rehabilitation setting.

All participants will undergo assessments before the start of the intervention and after completion of the 4-week program. Outcome measures will include pulmonary function tests (for example, FVC and FEV1), chest wall expansion, and trunk control ability. In addition, trunk function and functional mobility will be evaluated using the Korean version of the Trunk Impairment Scale (K-TIS) and the Five Times Sit-to-Stand Test (FTSTS), and perceived exertion during exercise will be assessed using the Borg Rating of Perceived Exertion (Borg RPE). Pre- to post-intervention changes will be calculated for each participant, and differences in these changes between the experimental and control groups will be analyzed.

The aim of this study is to determine whether a diaphragmatic breathing exercise using the air stacking technique provides additional benefits over conventional diaphragmatic breathing in improving pulmonary function, chest wall expansion, trunk control, and functional performance in patients with stroke. The findings are expected to demonstrate the therapeutic potential and clinical feasibility of an Ambu-bag-assisted air stacking technique and to contribute to the development of more effective respiratory and trunk rehabilitation strategies for individuals with stroke.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sør -Korea
    • Daegu
      • Daegu, Daegu, Sør -Korea, 41199
        • Daegu Fatima Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Air stacking-assisted diaphragmatic breathing
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.
Atferdsmessig: Air stacking-assisted diaphragmatic breathing
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.
Aktiv komparator: diaphragmatic breathing
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.
Atferdsmessig: diaphragmatic breathing
diaphragmatic breathing exercise performed three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Forced Vital Capacity (FVC)
Tidsramme: Baseline and 4 weeks after the start of intervention
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)
Tidsramme: Baseline and 4 weeks after the start of intervention
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
Tidsramme: Baseline and 4 weeks after the start of intervention
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)
Tidsramme: Baseline and 4 weeks after the start of intervention
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Trunk Function (Korean Version of the Trunk Impairment Scale, K-TIS)
Tidsramme: Baseline and 4 weeks after the start of intervention
Trunk function will be assessed using the Korean version of the Trunk Impairment Scale (K-TIS) at baseline and 4 weeks after the start of the intervention. The K-TIS is a clinical scale ranging from 0 to 23, with higher scores indicating better trunk function. The outcome measure is the change in K-TIS total score from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in Functional Lower Extremity Performance (Five Times Sit-to-Stand Test, FTSTS)
Tidsramme: Baseline and 4 weeks after the start of intervention
Functional lower extremity performance will be assessed using the Five Times Sit-to-Stand Test (FTSTS) at baseline and 4 weeks after the start of the intervention. The FTSTS records the time in seconds required to complete five repetitions of rising from and returning to a seated position. Higher times indicate poorer functional performance. The outcome measure is the change in FTSTS completion time from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in Perceived Exertion (Borg Rating of Perceived Exertion Scale)
Tidsramme: Baseline and 4 weeks after the start of intervention
Perceived exertion during breathing exercises will be assessed using the Borg Rating of Perceived Exertion Scale at baseline and 4 weeks after the start of the intervention. The Borg scale ranges from 6 to 20, with higher scores indicating greater perceived exertion. The outcome measure is the change in Borg scale score from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

jang ji-hun

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. september 2025

Primær fullføring (Faktiske)

21. februar 2026

Studiet fullført (Faktiske)

21. februar 2026

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-05-001

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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