Air Stacking-Assisted Diaphragmatic Breathing in Stroke (NCT07577076) | Clinical Trial Compass
CompletedNot Applicable
Air Stacking-Assisted Diaphragmatic Breathing in Stroke
South Korea20 participantsStarted 2025-09-25
Plain-language 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.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Forced Vital Capacity (FVC)
Timeframe: Baseline and 4 weeks after the start of intervention
2
Change in Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Baseline and 4 weeks after the start of intervention
3
Change in FEV1/FVC ratio
Timeframe: Baseline and 4 weeks after the start of intervention
4
Change in Peak Expiratory Flow (PEF)
Timeframe: Baseline and 4 weeks after the start of intervention