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

11 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

33

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Gwangju, Corea del Sur, 62287
        • Reclutamiento
        • Gwangju Health University
        • Contacto:
        • Contacto:
          • Seungwoo Shin Shin, Ph.D.
          • Número de teléfono: =82-10-9820-2382
          • Correo electrónico: ptssw94@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 34 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

Experimental: 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.

Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in dorsolateral prefrontal cortex oxygenated hemoglobin (HbO2) concentration measured by fNIRS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in diaphragm thickening fraction measured by ultrasound
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

14 de diciembre de 2026

Finalización primaria (Estimado)

14 de febrero de 2027

Finalización del estudio (Estimado)

30 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de 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 de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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