- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07620249
Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions
27. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yun Syuan Lin
- Telefonnummer: +886 986161796
- E-post: b11408046@ntu.edu.tw
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
Tar imot friske 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
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: 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).
|
|
Sham-komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Working Memory
Tidsramme: 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)
|
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Change from baseline in Inhibitory Control
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
Baseline and Week 5 (post-intervention)
|
|
Change in Posture Alignment
Tidsramme: Baseline and Week 5 (post-intervention)
|
|
Baseline and Week 5 (post-intervention)
|
|
Change in Psychological status
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Yan Ci Liu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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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 (Antatt)
25. mai 2026
Primær fullføring (Antatt)
1. februar 2027
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
11. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 202603092RIN
Plan for individuelle deltakerdata (IPD)
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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