Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

How Different Breathing Methods Affect Brain Activity in Young Adults With Chronic Ankle Instability (BRAIN-CAI)

11 listopada 2026 zaktualizowane przez: hyeongju Yoon, Gwangju Health University

Comparative Analysis of Breathing Intervention Types on Neural Activation in Young Adults With Chronic Ankle Instability: An fNIRS-EEG Randomized Controlled Trial

Chronic ankle instability is a common condition that can affect balance, movement control, and daily activities in young adults. Breathing exercises may influence brain function and attention, but their immediate effects on brain activity in individuals with chronic ankle instability are not well understood.

This randomized controlled trial aims to investigate the immediate effects of different breathing interventions on brain activity in young adults with chronic ankle instability. Participants will be randomly assigned to different breathing intervention groups. Brain activity will be assessed before and after the intervention using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG). The findings may improve understanding of the relationship between breathing exercises and brain function and support the development of rehabilitation strategies for individuals with chronic ankle instability.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Background and Rationale Chronic ankle instability (CAI) is a common sequela of lateral ankle sprain, characterized by recurrent giving way, perceived instability, and impaired dynamic balance. Growing evidence suggests that CAI involves not only peripheral deficits but also altered central nervous system processing, including changes in prefrontal cortical activity. Breathing-based interventions may influence postural control as well as cortical and autonomic regulation. However, it remains unclear how different types of breathing interventions compare in their immediate effects on brain activity in individuals with CAI. This study compared three breathing interventions: diaphragmatic breathing training, VR-based breathing meditation, and neurofeedback-based brain relaxation training.

Study Design This was a parallel-group, assessor-blinded randomized controlled trial. Thirty-three young adults with CAI were randomly allocated to one of three groups (n = 11 per group): the Diaphragmatic Breathing Group (DBG), the VR-based Breathing Meditation Group (VMG), or the Neurofeedback Brain Relaxation Training Group (NRG). Outcome assessors were blinded to group allocation. Each participant received a single intervention session according to group assignment, and outcomes were assessed before and immediately after the intervention. The study was designed and reported in accordance with the CONSORT guidelines.

Interventions The DBG performed diaphragmatic breathing training. The VMG performed breathing meditation delivered through a virtual reality environment. The NRG performed brain relaxation training based on EEG neurofeedback. The three groups differed in the type of breathing intervention while all received a single session. Detailed intervention procedures are described in the Arms and Interventions section.

Outcome Assessment The primary outcomes were cortical activity and EEG-based self-regulation indices. Cortical activity was measured by functional near-infrared spectroscopy (fNIRS) as oxygenated hemoglobin (HbO2) concentration in prefrontal regions of interest, including the dorsolateral prefrontal cortex, frontopolar cortex, orbitofrontal cortex, and medial prefrontal cortex. Neural self-regulation was evaluated using indices derived from EEG neurofeedback. The secondary outcomes were diaphragm contractility, measured as diaphragm thickening fraction using ultrasound; dynamic balance, measured by the Star Excursion Balance Test (SEBT); and ankle instability. Detailed outcome definitions and time frames are described in the Outcome Measures section.

Statistical Analysis Between-group differences were analyzed using analysis of variance (ANOVA), and within-group changes from pre- to post-intervention were analyzed using paired t-tests. Associations among fNIRS, EEG, and balance variables were examined using Pearson correlation analysis. Effect sizes were reported as Cohen's d. Bonferroni correction was applied where multiple comparisons were made. The significance level was set at 0.05.

Significance The findings of this study are expected to clarify how different types of breathing interventions immediately modulate prefrontal cortical activity and neural self-regulation in individuals with CAI, and to provide a basis for neuroscience-informed rehabilitation strategies for CAI.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

33

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

18 lat do 34 lata (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Young adults
  • CAIT-K score of ≤24
  • A history of at least one ankle sprain occurring at least 12 months prior to study enrollment
  • At least two episodes of ankle "giving way" within the 6months precending study enrollment

Exclusion Criteria:

  • A sprain of the involved ankle within 3 months prior to study enrollment
  • A History of lower-extremity surgery or fracture
  • A history of neurological disorder
  • The presence of cardiopulmonary disorder
  • Self-reported symptoms of cybersickness
  • Left-handedness

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: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Diaphragmatic brathing Training group

Participants in this group received diaphragmatic breathing training in a single session. Outcomes, including cortical activity, EEG indices, diaphragm contractility, dynamic balance, and ankle instability, were assessed before and immediately after the session.
Behawioralne: Diaphragmatic Breathing Training

Participants assigned to this intervention will perform diaphragmatic breathing training in a single session. Participants will be guided to breathe using the diaphragm, and the training will be delivered under the supervision of a trained researcher.
Eksperymentalny: VR-based breathing meditation group

Participants in this group received breathing meditation delivered through a virtual reality environment in a single session. Outcomes, including cortical activity, EEG indices, diaphragm contractility, dynamic balance, and ankle instability, were assessed before and immediately after the session.
Behawioralne: VR-based Breathing Meditation

Participants assigned to this intervention will perform breathing meditation delivered through a virtual reality environment in a single session. Participants will wear a VR headset and follow the breathing meditation content presented in the virtual environment.
Eksperymentalny: Neurofeedback relaxation training group

Participants in this group received brain relaxation training based on EEG neurofeedback in a single session. Outcomes, including cortical activity, EEG indices, diaphragm contractility, dynamic balance, and ankle instability, were assessed before and immediately after the session.
Behawioralne: Neurofeedback Brain Relaxation Training

Participants assigned to this intervention will perform brain relaxation training based on EEG neurofeedback in a single session. Participants will receive real-time feedback on their EEG activity and will be trained to achieve a relaxed brain state.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in dorsolateral prefrontal cortex oxygenated hemoglobin (HbO2) concentration measured by fNIRS
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Oxygenated hemoglobin (HbO2) concentration was measured by functional near-infrared spectroscopy (fNIRS) in the dorsolateral prefrontal cortex. Change was calculated as the difference between pre- and post-intervention values.
Baseline (before the intervention) and immediately after the single intervention session
Change in frontopolar cortex oxygenated hemoglobin (HbO2) concentration measured by fNIRS
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Oxygenated hemoglobin (HbO2) concentration was measured by functional near-infrared spectroscopy (fNIRS) in the frontopolar cortex. Change was calculated as the difference between pre- and post-intervention values.
Baseline (before the intervention) and immediately after the single intervention session
Change in orbitofrontal cortex oxygenated hemoglobin (HbO2) concentration measured by fNIRS
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Oxygenated hemoglobin (HbO2) concentration was measured by functional near-infrared spectroscopy (fNIRS) in the orbitofrontal cortex. Change was calculated as the difference between pre- and post-intervention values.
Baseline (before the intervention) and immediately after the single intervention session
Change in medial prefrontal cortex oxygenated hemoglobin (HbO2) concentration measured by fNIRS
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Oxygenated hemoglobin (HbO2) concentration was measured by functional near-infrared spectroscopy (fNIRS) in the medial prefrontal cortex. Change was calculated as the difference between pre- and post-intervention values.
Baseline (before the intervention) and immediately after the single intervention session
Change in EEG delta band power
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Delta band (0.5-4 Hz) power was measured by electroencephalography (EEG) at [electrode site(s)]. Change was calculated as the difference between pre- and post-intervention values. Unit: [µV²].
Baseline (before the intervention) and immediately after the single intervention session
Change in EEG theta band power
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Theta band (4-8 Hz) power was measured by electroencephalography (EEG) at [electrode site(s)]. Change was calculated as the difference between pre- and post-intervention values. Unit: [µV²].
Baseline (before the intervention) and immediately after the single intervention session
Change in EEG alpha band power
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Alpha band (8-12 Hz) power was measured by electroencephalography (EEG) at [electrode site(s)]. Change was calculated as the difference between pre- and post-intervention values. Unit: [µV²].
Baseline (before the intervention) and immediately after the single intervention session
Change in EEG sensorimotor rhythm (SMR) band power
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Sensorimotor rhythm (SMR) band (12-15 Hz) power was measured by electroencephalography (EEG) at [electrode site(s)]. Change was calculated as the difference between pre- and post-intervention values. Unit: [µV²].
Baseline (before the intervention) and immediately after the single intervention session
Change in EEG beta band power
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Beta band (15-30 Hz) power was measured by electroencephalography (EEG) at [electrode site(s)]. Change was calculated as the difference between pre- and post-intervention values. Unit: [µV²].
Baseline (before the intervention) and immediately after the single intervention session

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in diaphragm thickening fraction measured by ultrasound
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Diaphragm thickness was measured by ultrasound at end-inspiration and end-expiration, and the diaphragm thickening fraction was calculated as (end-inspiration thickness - end-expiration thickness) / end-expiration thickness × 100 (%). Change was calculated as the difference between pre- and post-intervention values.
Baseline (before the intervention) and immediately after the single intervention session
Change in dynamic balance measured by the Star Excursion Balance Test (SEBT)
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Dynamic balance was assessed by the Star Excursion Balance Test (SEBT), in which participants reached as far as possible with the free limb while standing on the affected limb. Reach distance was measured in each direction, and change was calculated as the difference between pre- and post-intervention values.
Baseline (before the intervention) and immediately after the single intervention session
Change in ankle instability measured by CAIT-K
Ramy czasowe: Baseline (before the intervention) and immediately after the single intervention session

Ankle instability was assessed using [instrument name]. Change was calculated as the difference between pre- and post-intervention scores.
Baseline (before the intervention) and immediately after the single intervention session

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gwangju Health University

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)

14 grudnia 2026

Zakończenie podstawowe (Szacowany)

14 lutego 2027

Ukończenie studiów (Szacowany)

30 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

4 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 listopada 2026

Pierwszy wysłany (Rzeczywisty)

13 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • P01-202610-01-075

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified individual participant data underlying the results reported in the publication will be shared with qualified researchers upon reasonable request to the corresponding author. Data will be available after publication of the main results.

Ramy czasowe udostępniania IPD

Data will be available beginning 6 months after publication of the main results

Kryteria dostępu do udostępniania IPD

Qualified researchers may request access to de-identified individual participant data by contacting the corresponding author. Requests will be reviewed by the research team, and data will be shared for academic research purposes.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

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 .

Subskrybuj