- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07620249
Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions
27. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yun Syuan Lin
- Telefonnummer: +886 986161796
- E-mail: b11408046@ntu.edu.tw
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Sham-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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in Working Memory
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Baseline, Week 5 (post-intervention)
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Change from baseline in Short-Term Memory
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Heart Rate Variability (HRV)
Tidsramme: 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.
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Baseline and Week 5 (post-intervention)
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Change in Posture Alignment
Tidsramme: Baseline and Week 5 (post-intervention)
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Baseline and Week 5 (post-intervention)
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Change in Psychological status
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Yan Ci Liu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. maj 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
27. maj 2026
Først opslået (Faktiske)
2. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 202603092RIN
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