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

11 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

33

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Gwangju, Corea del Sud, 62287
        • Reclutamento
        • Gwangju Health University
        • Contatto:
        • Contatto:
          • Seungwoo Shin Shin, Ph.D.
          • Numero di telefono: =82-10-9820-2382
          • Email: ptssw94@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 34 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.

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.

Sperimentale: 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.

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.

Sperimentale: 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in dorsolateral prefrontal cortex oxygenated hemoglobin (HbO2) concentration measured by fNIRS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in diaphragm thickening fraction measured by ultrasound
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

14 dicembre 2026

Completamento primario (Stimato)

14 febbraio 2027

Completamento dello studio (Stimato)

30 marzo 2027

Date di iscrizione allo studio

Primo inviato

4 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

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Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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