- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07620249
Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions
27 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Yun Syuan Lin
- Номер телефона: +886 986161796
- Электронная почта: b11408046@ntu.edu.tw
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
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).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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).
|
|
Фальшивый компаратор: natural breathing exercise group
The natural breathing exercise group performed sham thoracic expansion exercises and sham slow diaphragmatic breathing
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from baseline in Working Memory
Временное ограничение: Baseline, Week 5 (post-intervention)
|
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.
|
Baseline, Week 5 (post-intervention)
|
|
Change from baseline in Inhibitory Control
Временное ограничение: Baseline, Week 5 (post-intervention)
|
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.
|
Baseline, Week 5 (post-intervention)
|
|
Change from baseline in Mental Set Shifting
Временное ограничение: Baseline, Week 5 (post-intervention)
|
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.
|
Baseline, Week 5 (post-intervention)
|
|
Change from baseline in Short-Term Memory
Временное ограничение: Baseline, Week 5 (post-intervention)
|
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.
|
Baseline, Week 5 (post-intervention)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Heart Rate Variability (HRV)
Временное ограничение: Baseline and Week 5 (post-intervention)
|
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.
|
Baseline and Week 5 (post-intervention)
|
|
Change in Posture Alignment
Временное ограничение: Baseline and Week 5 (post-intervention)
|
|
Baseline and Week 5 (post-intervention)
|
|
Change in Psychological status
Временное ограничение: Baseline and Week 5 (post-intervention)
|
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.
|
Baseline and Week 5 (post-intervention)
|
|
Change in Brain Activation
Временное ограничение: Baseline and Week 5 (post-intervention)
|
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.
|
Baseline and Week 5 (post-intervention)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Yan Ci Liu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Verbruggen F, Logan GD. Response inhibition in the stop-signal paradigm. Trends Cogn Sci. 2008 Nov;12(11):418-24. doi: 10.1016/j.tics.2008.07.005.
- Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.
- Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Stoet G. PsyToolkit: a software package for programming psychological experiments using Linux. Behav Res Methods. 2010 Nov;42(4):1096-104. doi: 10.3758/BRM.42.4.1096.
- Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.
- Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7.
- Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015.
- Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.
- Ma X, Yue ZQ, Gong ZQ, Zhang H, Duan NY, Shi YT, Wei GX, Li YF. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017 Jun 6;8:874. doi: 10.3389/fpsyg.2017.00874. eCollection 2017.
- 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.
- Ferreira L, Tanaka K, Santos-Galduroz RF, Galduroz JC. Respiratory training as strategy to prevent cognitive decline in aging: a randomized controlled trial. Clin Interv Aging. 2015 Mar 20;10:593-603. doi: 10.2147/CIA.S79560. eCollection 2015.
- Katzman WB, Wanek L, Shepherd JA, Sellmeyer DE. Age-related hyperkyphosis: its causes, consequences, and management. J Orthop Sports Phys Ther. 2010 Jun;40(6):352-60. doi: 10.2519/jospt.2010.3099.
- 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.
- Molavi B, Dumont GA. Wavelet-based motion artifact removal for functional near-infrared spectroscopy. Physiol Meas. 2012 Feb;33(2):259-70. doi: 10.1088/0967-3334/33/2/259. Epub 2012 Jan 25.
- Oostenveld R, Praamstra P. The five percent electrode system for high-resolution EEG and ERP measurements. Clin Neurophysiol. 2001 Apr;112(4):713-9. doi: 10.1016/s1388-2457(00)00527-7.
- Shaghayegh Fard B, Ahmadi A, Maroufi N, Sarrafzadeh J. Evaluation of forward head posture in sitting and standing positions. Eur Spine J. 2016 Nov;25(11):3577-3582. doi: 10.1007/s00586-015-4254-x. Epub 2015 Oct 17.
- 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.
- Dareh-Deh HR, Hadadnezhad M, Letafatkar A, Peolsson A. Therapeutic routine with respiratory exercises improves posture, muscle activity, and respiratory pattern of patients with neck pain: a randomized controlled trial. Sci Rep. 2022 Mar 9;12(1):4149. doi: 10.1038/s41598-022-08128-w.
- Tsui AYY, Chau RMW, Cheing GLY, Mok TYW, Ling SO, Kwan CHY, Tsang SMH. Effect of chest wall mobilization on respiratory muscle function in patients with severe chronic obstructive pulmonary disease (COPD): A randomized controlled trial. Respir Med. 2023 Dec;220:107436. doi: 10.1016/j.rmed.2023.107436. Epub 2023 Nov 2.
- Tachibana Y, Godai K, Kabayama M, Akagi Y, Kido M, Hosokawa M, Akasaka H, Takami Y, Yamamoto K, Yasumoto S, Masui Y, Ikebe K, Arai Y, Ishizaki T, Gondo Y, Kamide K. Relationship between respiratory function assessed by spirometry and mild cognitive impairment among community-dwelling older adults. Geriatr Gerontol Int. 2024 Oct;24(10):1001-1007. doi: 10.1111/ggi.14962. Epub 2024 Aug 20.
- Zafar H, Albarrati A, Alghadir AH, Iqbal ZA. Effect of Different Head-Neck Postures on the Respiratory Function in Healthy Males. Biomed Res Int. 2018 Jul 12;2018:4518269. doi: 10.1155/2018/4518269. eCollection 2018.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
25 мая 2026 г.
Первичное завершение (Оцененный)
1 февраля 2027 г.
Завершение исследования (Оцененный)
1 февраля 2027 г.
Даты регистрации исследования
Первый отправленный
11 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
27 мая 2026 г.
Первый опубликованный (Действительный)
2 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
2 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 202603092RIN
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Диафрагменная стимуляция
-
University Hospitals, LeicesterMedtronicРекрутинг