- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07620249
Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions
27 maja 2026 zaktualizowane przez: National Taiwan University Clinical Trial Center
The Effects of Combined Thoracic Expansion Exercises and Slow Diaphragmatic Breathing on Cognitive Function, Brain Activation, Psychological Status, and Head-Shoulder Posture in Healthy Adults
This study aims to investigate the effects of a combined thoracic expansion exercise (TEE) and slow diaphragmatic breathing (SDB) program on cognitive function, brain activation, psychological status, and head-shoulder posture in healthy young adults.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Yun Syuan Lin
- Numer telefonu: +886 986161796
- E-mail: b11408046@ntu.edu.tw
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- age between 18 to 30 years with at least a high school education to ensure baseline cognitive task comprehension
- the ability to adhere to verbal instructions
- no regular participation in formal breathing exercise or mindfulness training within the past six months.
Exclusion Criteria:
- a history of musculoskeletal, cardiovascular, or cerebrovascular diseases which may interfere this study
- history of respiratory disease or recent respiratory infection
- diabetes mellitus with neuropathy, peripheral neuropathy, or other neurological disorders
- major surgery within the past six months
- Current or past major psychiatric disorders or cognitive impairment
- use of medications significantly affecting cerebral hemodynamics or autonomic function (e.g., beta-blockers, vasodilators) within the past 2 weeks
- use of psychotropic medications or substances known to alter cerebral blood flow, neural activation, or autonomic regulation (e.g., antidepressants, antipsychotics, anxiolytics, stimulants, or sedative-hypnotics).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: rhythmic breathing exercise group
The rhythmic breathing exercise group will perform 10 minutes of thoracic expansion exercises followed by 15 minutes of progressive diaphragmatic breathing (4-s inhalation/6-s exhalation) to facilitate parasympathetic dominance.
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4-week supervised training program, consisting of three 30-minute sessions per week.
Thoracic expansion exercises consists of chest wall stretching and mobility drills.
Followed by 15 minutes of progressive slow diaphragmatic breathing (4-s inhalation/6-s exhalation).
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Pozorny komparator: natural breathing exercise group
The natural breathing exercise group performed sham thoracic expansion exercises and sham slow diaphragmatic breathing
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During sham TEE, participants perform comfortable thoracic movements without foam rollers or specific breathing coordination.
During sham SDB, they maintain a spontaneous, natural respiratory rhythm in relaxed postures.
Crucially, the sham protocol lacks the rhythmic pacing (4:6s), diaphragmatic depth cues, and resistance-based progression required to trigger the neuro-cognitive "respiratory-brain" axis.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from baseline in Working Memory
Ramy czasowe: Baseline, Week 5 (post-intervention)
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Assessed by the 2-back task.
The outcome is calculated as the change in accuracy (percentage of correct responses) and reaction time.
Accuracy range from 0% to 100%.
Higher accuracy and lower reaction time indicate better working memory capacity.
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Baseline, Week 5 (post-intervention)
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Change from baseline in Inhibitory Control
Ramy czasowe: Baseline, Week 5 (post-intervention)
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Measured by the Stop-signal task (SST).
The outcome is the change in Stop-Signal Reaction Time (SSRT) in milliseconds.
SSRT values typically range from 100 to 500 milliseconds, with lower scores (faster reaction time) indicating better inhibitory control.
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Baseline, Week 5 (post-intervention)
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Change from baseline in Mental Set Shifting
Ramy czasowe: Baseline, Week 5 (post-intervention)
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Assessed using the Wisconsin Card Sorting Test (WCST).
The outcome include the number of categories achieved, perseverative errors and set-loss errors.
Higher number of categories achieved, lower perseverative errors and set-loss errors indicate better cognitive flexibility and set-shifting ability.
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Baseline, Week 5 (post-intervention)
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Change from baseline in Short-Term Memory
Ramy czasowe: Baseline, Week 5 (post-intervention)
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Assessed using the Corsi Block-Tapping Task.
The outcome is Corsi span score.
The Corsi span is defined as the longest sequence accurately reproduced by participants.
Scores range from 0 to 9 blocks, with higher scores indicating better short-term memory capacity.
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Baseline, Week 5 (post-intervention)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Heart Rate Variability (HRV)
Ramy czasowe: Baseline and Week 5 (post-intervention)
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HRV will be assessed as a non-invasive marker of autonomic nervous system (ANS) flexibility and neurovisceral integration, reflecting the dynamic regulation of the prefrontal-vagal pathway.
Higher HRV serves as a physiological indicator of superior executive function and emotional regulation, whereas lower values are linked to autonomic dysregulation and cognitive fatigue.
Data will be captured using a validated Polar H10 chest strap and the Elite HRV application for precise R-R interval detection.
Outcome measurement include time-domain indices (SDNN, RMSSD), frequency-domain measures (HF, LF, and LF/HF ratio), and non-linear metrics (SD1, SD2).
Increased RMSSD and HF power will be interpreted as enhanced parasympathetic modulation, providing the physiological foundation for improved attentional control and neural efficiency.
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Baseline and Week 5 (post-intervention)
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Change in Posture Alignment
Ramy czasowe: Baseline and Week 5 (post-intervention)
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Baseline and Week 5 (post-intervention)
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Change in Psychological status
Ramy czasowe: Baseline and Week 5 (post-intervention)
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The Traditional Chinese version of Depression Anxiety Stress Scales-21 (DASS-21) will be used to assess negative emotional states including depression, anxiety, and stress.
DASS-21 contains 21 items, with 7 items assigned to each subscale.
Participants rate their symptoms over the past week on a 4-point scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time") in each question.
Subscale scores are obtained by summing the 7 items and multiply by two within each domain, with higher scores indicating greater severity of emotional distress.
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Baseline and Week 5 (post-intervention)
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Change in Brain Activation
Ramy czasowe: Baseline and Week 5 (post-intervention)
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Brain activation in the prefrontal cortex, primary motor cortex, supplementary motor area, and premotor cortex during tasks is assessed using functional near-infrared spectroscopy (fNIRS).
The specific metric reported is the change in the concentration of oxygenated hemoglobin (HbO).
Higher HbO values indicate increased regional cerebral blood flow and higher brain activation.
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Baseline and Week 5 (post-intervention)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Yan Ci Liu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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- Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.
- Piper SK, Krueger A, Koch SP, Mehnert J, Habermehl C, Steinbrink J, Obrig H, Schmitz CH. A wearable multi-channel fNIRS system for brain imaging in freely moving subjects. Neuroimage. 2014 Jan 15;85 Pt 1(0 1):64-71. doi: 10.1016/j.neuroimage.2013.06.062. Epub 2013 Jun 28.
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- Baek CY, Yoon HS, Kim HD, Kang KY. The effect of the degree of dual-task interference on gait, dual-task cost, cognitive ability, balance, and fall efficacy in people with stroke: A cross-sectional study. Medicine (Baltimore). 2021 Jun 18;100(24):e26275. doi: 10.1097/MD.0000000000026275.
- Kopp B, Lange F, Steinke A. The Reliability of the Wisconsin Card Sorting Test in Clinical Practice. Assessment. 2021 Jan;28(1):248-263. doi: 10.1177/1073191119866257. Epub 2019 Aug 2.
- Yeung MK, Han YMY. Changes in task performance and frontal cortex activation within and over sessions during the n-back task. Sci Rep. 2023 Feb 27;13(1):3363. doi: 10.1038/s41598-023-30552-9.
- Bianchini E, Warmerdam E, Romijnders R, Hansen C, Pontieri FE, Maetzler W. Cognitive dual-task cost depends on the complexity of the cognitive task, but not on age and disease. Front Neurol. 2022 Oct 3;13:964207. doi: 10.3389/fneur.2022.964207. eCollection 2022.
- Khng KH, Lee K. The relationship between Stroop and stop-signal measures of inhibition in adolescents: influences from variations in context and measure estimation. PLoS One. 2014 Jul 3;9(7):e101356. doi: 10.1371/journal.pone.0101356. eCollection 2014.
- Voss A, Schroeder R, Heitmann A, Peters A, Perz S. Short-term heart rate variability--influence of gender and age in healthy subjects. PLoS One. 2015 Mar 30;10(3):e0118308. doi: 10.1371/journal.pone.0118308. eCollection 2015.
- Nazir S, Mathiyakom W, Tassawar MA, Tantisuwat A. The effect of diaphragmatic breathing and diaphragmatic mobilization on physical performance, fear of falling, and quality of life in community-dwelling older adults: A randomized controlled trial. PLoS One. 2026 Jan 5;21(1):e0339868. doi: 10.1371/journal.pone.0339868. eCollection 2026.
- Ren Y, Cui G, Zhang X, Feng K, Yu C, Liu P. The promising fNIRS: Uncovering the function of prefrontal working memory networks based on multi-cognitive tasks. Front Psychiatry. 2022 Oct 25;13:985076. doi: 10.3389/fpsyt.2022.985076. eCollection 2022.
- Catai AM, Pastre CM, Godoy MF, Silva ED, Takahashi ACM, Vanderlei LCM. Heart rate variability: are you using it properly? Standardisation checklist of procedures. Braz J Phys Ther. 2020 Mar-Apr;24(2):91-102. doi: 10.1016/j.bjpt.2019.02.006. Epub 2019 Feb 26.
- Duan Y, Guo X, Ren B, Liu F, Li Y, Liu F, Xu F, Huang M. An alternating breathing pattern significantly affects the brain functional connectivity and mood states. Front Hum Neurosci. 2025 Apr 16;19:1539222. doi: 10.3389/fnhum.2025.1539222. eCollection 2025.
- Rodrigo AH, Di Domenico SI, Graves B, Lam J, Ayaz H, Bagby RM, Ruocco AC. Linking trait-based phenotypes to prefrontal cortex activation during inhibitory control. Soc Cogn Affect Neurosci. 2016 Jan;11(1):55-65. doi: 10.1093/scan/nsv091. Epub 2015 Jul 10.
- Kelly VE, Janke AA, Shumway-Cook A. Effects of instructed focus and task difficulty on concurrent walking and cognitive task performance in healthy young adults. Exp Brain Res. 2010 Nov;207(1-2):65-73. doi: 10.1007/s00221-010-2429-6. Epub 2010 Oct 8.
- Ji X, Quan W, Yang L, Chen J, Wang J, Wu T. Classification of Schizophrenia by Seed-based Functional Connectivity using Prefronto-Temporal Functional Near Infrared Spectroscopy. J Neurosci Methods. 2020 Oct 1;344:108874. doi: 10.1016/j.jneumeth.2020.108874. Epub 2020 Jul 23.
- Boas DA, Gaudette T, Strangman G, Cheng X, Marota JJ, Mandeville JB. The accuracy of near infrared spectroscopy and imaging during focal changes in cerebral hemodynamics. Neuroimage. 2001 Jan;13(1):76-90. doi: 10.1006/nimg.2000.0674.
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- Kane MJ, Conway ARA, Miura TK, Colflesh GJH. Working memory, attention control, and the N-back task: a question of construct validity. J Exp Psychol Learn Mem Cogn. 2007 May;33(3):615-622. doi: 10.1037/0278-7393.33.3.615.
- Jaeggi SM, Buschkuehl M, Perrig WJ, Meier B. The concurrent validity of the N-back task as a working memory measure. Memory. 2010 May;18(4):394-412. doi: 10.1080/09658211003702171. Epub 2010 Apr 19.
- Yokoyama S, Gamada K, Sugino S, Sasano R. The effect of "the core conditioning exercises" using the stretch pole on thoracic expansion difference in healthy middle-aged and elderly persons. J Bodyw Mov Ther. 2012 Jul;16(3):326-329. doi: 10.1016/j.jbmt.2011.10.002. Epub 2011 Nov 9.
- Lee SH, Park DS, Song CH. The Effect of Deep and Slow Breathing on Retention and Cognitive Function in the Elderly Population. Healthcare (Basel). 2023 Mar 20;11(6):896. doi: 10.3390/healthcare11060896.
- Masmoudi K, Chaari F, Ben Waer F, Rebai H, Sahli S. A single session of slow-paced breathing improved cognitive functions and postural control among middle-aged women: a randomized single blinded controlled trial. Menopause. 2025 Feb 1;32(2):158-165. doi: 10.1097/GME.0000000000002470. Epub 2024 Dec 17.
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
25 maja 2026
Zakończenie podstawowe (Szacowany)
1 lutego 2027
Ukończenie studiów (Szacowany)
1 lutego 2027
Daty rejestracji na studia
Pierwszy przesłany
11 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 maja 2026
Pierwszy wysłany (Rzeczywisty)
2 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 202603092RIN
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Stymulacja przepony
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University of RochesterNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...RekrutacyjnyNiewydolność serca | Terapia resynchronizująca serca | Blok prawej odnogi pęczka Hisa | Pacing HisaStany Zjednoczone