- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07738809
Effects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms
Effects of Exercise Intervention on Sleep Quality, Emotional Problems, and Neuroelectrophysiological Mechanisms in College Students With Depressive Symptoms
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depressive symptoms are highly prevalent among college students and are frequently accompanied by poor sleep quality, emotional disturbances, impaired executive function, and altered brain activity. Although physical exercise has been recognized as an effective non-pharmacological intervention for improving mental health, the neurophysiological mechanisms underlying these benefits remain unclear.
This study adopts an exploratory randomized controlled design consisting of two consecutive phases. In Phase I, participants will complete a single session of low-to-moderate intensity exercise to investigate immediate changes in emotional state, executive function, resting-state EEG, brain functional connectivity, and event-related potentials (ERP). In Phase II, the same participants will continue to participate in an 8-week exercise intervention to examine the effects of regular exercise on sleep quality, depressive symptoms, emotional problems, executive function, and neurophysiological characteristics.
Behavioral assessments, standardized psychological questionnaires, resting-state EEG, brain functional connectivity analysis, and ERP recordings will be performed before and after intervention. The study will also investigate whether the immediate response to acute exercise is associated with subsequent improvements following long-term exercise intervention, providing evidence for individualized exercise prescriptions and neurophysiological mechanisms of exercise in college students with depressive symptoms.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yongguo Zhu, Professor
- Número de teléfono: +86 13811265116
- Correo electrónico: zhuyongguo@cupes.edu.cn
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana
- Shanghai University of Sport
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Contacto:
- Yongguo Zhu, Professor
- Número de teléfono: +86 13811265116
- Correo electrónico: zhuyongguo@cupes.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
• Aged 18-23 years.
- Right-handed.
- Non-physical education major.
- No history of psychiatric disorders and no current or previous use of psychotropic medications, hypnotics, or other medications affecting the central nervous system.
- No history of traumatic brain injury or chronic physical diseases.
- No contraindications to physical exercise.
- Participants with a Beck Depression Inventory-II (BDI-II) score >13 will be classified as having depressive symptoms, whereas participants with a BDI-II score ≤13 will be classified as having no depressive symptoms.
Exclusion Criteria:
Vigorous physical exercise, alcohol consumption, caffeine intake, or other stimulating behaviors within 24 hours before testing.
- Withdrawal from the study before completion of EEG recording or behavioral task assessments.
- Participants will be excluded from the final analysis if they fail to complete the required questionnaires or if the collected data do not meet predefined quality control criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Archery Exercise Group
Participants assigned to this group will first complete one supervised session of low-to-moderate intensity archery exercise and will subsequently participate in an 8-week regular archery exercise program.
The acute exercise session consists of a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down.
The 8-week intervention will be conducted three times per week, with at least 48 hours between sessions.
Exercise intensity will be maintained at 50%-75% of age-predicted maximum heart rate and monitored using heart rate and ratings of perceived exertion.
Psychological questionnaires, behavioral tasks, resting-state EEG, and task-related ERP assessments will be completed before and after the acute session and before and after the 8-week intervention.
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Participants perform a standardized archery exercise program consisting of an acute exercise session followed by an 8-week supervised training program.
The acute session includes a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down.
The long-term intervention is conducted three times per week for 8 weeks at moderate exercise intensity.
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Comparador activo: Control Group
Participants assigned to this group will complete an equal-duration seated rest or non-exercise control activity during the acute experiment.
During the subsequent 8-week period, participants will maintain their usual lifestyle and attend the laboratory three times per week at the same scheduled times as the exercise group to complete 30 minutes of seated rest or another non-exercise control activity.
Psychological questionnaires, behavioral tasks, resting-state EEG, and task-related ERP assessments will be completed at the same assessment time points as those in the archery exercise group.
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Participants continue their usual daily activities without participating in the archery exercise intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Depressive symptoms measured by the Beck Depression Inventory-II (BDI-II)
Periodo de tiempo: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II).
Changes in depressive symptom severity following acute and long-term archery exercise interventions will be evaluated.
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Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Changes in sleep quality after acute and long-term archery exercise interventions will be evaluated.
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Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Resting-state EEG functional connectivity
Periodo de tiempo: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Resting-state EEG functional connectivity will be analyzed using phase synchronization metrics to evaluate neural changes associated with archery exercise interventions.
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Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Yongguo Zhu, Professor, Capital University of Physical Education and Sports
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026A137
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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