Efectos del Ejercicio Baduanjin en la Mejora de la Salud en Adultos Jóvenes y de Mediana Edad Sedentarios
Un Ensayo Multicéntrico, Aleatorizado y Controlado para Evaluar la Eficacia y los Mecanismos de Baduanjin en la Mejora de los Resultados de Salud en Adultos Jóvenes y de Mediana Edad Sedentarios
The goal of this clinical trial is to learn if a 12-week Baduanjin exercise program can improve health in sedentary young and middle-aged adults. The main questions it aims to answer are:
- Does the Baduanjin program improve participants' cardiorespiratory fitness (measured as peak oxygen uptake)?
- Does it improve their body composition, muscle strength, balance, and flexibility?
- Does it reduce their daily sitting time?
Researchers will compare the Baduanjin training group to a health education control group to see if Baduanjin is more effective in improving these health outcomes.
Participants will:
- Be randomly assigned to one of the two groups.
- If in the Baduanjin group, attend supervised group sessions and practice at home for 12 weeks.
- Complete a series of assessments at the beginning, middle, and end of the study, including fitness tests, body measurements, and questionnaires.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jingyi Ren, M.D., Chief Physician
- Número de teléfono: 18600195099
- Correo electrónico: renjingyi@cjfh.org.cn
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Reclutamiento
- China-Japan Friendship Hospital
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Contacto:
- Jingyi Ren, Doctor
- Número de teléfono: +86 17367938350
- Correo electrónico: 1220193509@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults aged 18 to 59 years
- Sedentary and physically inactive, defined as: (a) self-reported sitting time ≥ 8 hours per day, AND (b) not meeting the World Health Organization (WHO) recommended level of physical activity ( engaging in < 150 minutes of moderate-to-vigorous intensity physical activity per week, assessed by the International Physical Activity Questionnaire [IPAQ])
- In good general health as self-reported, and free from any known diseases
- Willing and able to provide written informed consent
Exclusion Criteria:
- Contraindications to cardiopulmonary exercise testing
- Currently participating in, or planning to participate within the next 3 months, in any other structured exercise or behavioral intervention program
- Pregnancy, lactation, or planning to become pregnant during the study period
- Inability to understand or comply with the study procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Baduanjin Training Group
Participants in this group will receive a 12-week Baduanjin exercise program. The program consists of supervised group sessions combined with home-based practice, with a frequency of 5 sessions per week. Each session lasts 60 minutes, including warm-up, standardized Baduanjin practice, and cool-down. The Baduanjin exercises follow a standardized protocol. |
A 12-week, standardized Baduanjin exercise program. Participants will complete 5 sessions per week, each lasting 60 minutes (including warm-up, Baduanjin practice, and cool-down). The program includes both supervised group sessions and guided home practice. |
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Otro: Health Education Control Group
Participants in this group will receive general health education, which includes recommendations on physical activity types and duration (e.g., following the WHO guidelines). However, they will not be enrolled in any structured, supervised exercise program. They will be instructed to maintain their usual lifestyle throughout the study period. |
Participants will receive general health education (including recommendations on physical activity types and duration), but will not be enrolled in any structured or supervised exercise program. They will be instructed to maintain their usual lifestyle. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Peak Oxygen Uptake (VO₂peak) assessed by Cardiopulmonary Exercise Testing
Periodo de tiempo: at baseline and Week 13.
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Measured by Cardiopulmonary Exercise Testing (CPET). |
at baseline and Week 13.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio en el Tiempo Dedicado al Comportamiento Sedentario evaluado mediante el Cuestionario Internacional de Actividad Física (IPAQ)
Periodo de tiempo: al inicio y en la semana 13.
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al inicio y en la semana 13.
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Cambio en la Potencia Media de Extensión de Rodilla evaluada mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13.
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al inicio, en la semana 8 y en la semana 13.
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|
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Cambio en el Índice de Fatiga de la Extensión de Rodilla evaluado mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, la semana 8 y la semana 13.
|
al inicio, la semana 8 y la semana 13.
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|
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Cambio en la Potencia Promedio de Flexión de Rodilla evaluada mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13
|
al inicio, en la semana 8 y en la semana 13
|
|
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Cambio en el Índice de Fatiga de la Flexión de Rodilla evaluado mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13
|
al inicio, en la semana 8 y en la semana 13
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|
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Cambio en la Potencia Promedio de Flexión del Hombro evaluada mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13
|
al inicio, en la semana 8 y en la semana 13
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|
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Cambio en el Índice de Fatiga de la Flexión del Hombro evaluado mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, la semana 8 y la semana 13
|
al inicio, la semana 8 y la semana 13
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|
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Cambio en la Potencia Media de Abducción del Hombro evaluada mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, la semana 8 y la semana 13
|
al inicio, la semana 8 y la semana 13
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|
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Cambio en el Índice de Fatiga de la Abducción del Hombro evaluado mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13
|
al inicio, en la semana 8 y en la semana 13
|
|
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Cambio en la Potencia Media de Extensión del Codo evaluada mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, Semana 8 y Semana 13
|
al inicio, Semana 8 y Semana 13
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Cambio en el Índice de Fatiga de la Extensión del Codo evaluado mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, la semana 8 y la semana 13
|
al inicio, la semana 8 y la semana 13
|
|
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Cambio en la Potencia Media de Flexión de Codo evaluada mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13
|
al inicio, en la semana 8 y en la semana 13
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|
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Cambio en el Índice de Fatiga de la Flexión del Codo evaluado mediante Dinamometría Isocinética
Periodo de tiempo: al inicio, en la semana 8 y en la semana 13
|
al inicio, en la semana 8 y en la semana 13
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Cambio en la masa muscular evaluado mediante análisis de impedancia bioeléctrica
Periodo de tiempo: al inicio y en la Semana 13.
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al inicio y en la Semana 13.
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Cambio en el porcentaje de grasa corporal evaluado mediante Análisis de Impedancia Bioeléctrica
Periodo de tiempo: al inicio y en la semana 13.
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al inicio y en la semana 13.
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Cambio en la Masa Libre de Grasa evaluada mediante Análisis de Impedancia Bioeléctrica
Periodo de tiempo: en la línea de base y la semana 13.
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en la línea de base y la semana 13.
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Cambio en la Altura del Centro de Masa durante el Ejercicio Baduanjin evaluado mediante Captura de Movimiento 3D
Periodo de tiempo: al inicio y en la Semana 13
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al inicio y en la Semana 13
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Cambio en la Electromiografía Integrada (iEMG) durante el Ejercicio Baduanjin evaluado mediante Electromiografía Superficial
Periodo de tiempo: al inicio y en la semana 13
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al inicio y en la semana 13
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Cambio en la amplitud de la raíz cuadrática media (RMS) durante el ejercicio Baduanjin evaluado mediante electromiografía de superficie
Periodo de tiempo: al inicio y en la semana 13
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al inicio y en la semana 13
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Porcentaje de sesiones prescritas de Baduanjin completadas
Periodo de tiempo: Hasta la finalización del estudio, hasta la semana 13.
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Hasta la finalización del estudio, hasta la semana 13.
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Change in Sit-and-Reach Distance
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Assessed by the standard sit-and-reach test. |
at baseline, Week 8, and Week 13.
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Change in Active Range of Motion of the Shoulder, Hip, Knee, and Ankle joints assessed by Goniometry
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Measured using a goniometer |
at baseline, Week 8, and Week 13.
|
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Scores on the Exercise Benefits/Barriers Scale (EBBS)
Periodo de tiempo: at baseline and Week 13
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The scale consists of two subscales: the Exercise Benefits Subscale (29 items) and the Exercise Barriers Subscale (14 items). The total score ranges from 43 to 172, with a higher score indicating a more positive perception towards exercise. |
at baseline and Week 13
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Change in Knee Extension Peak Torque assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Maximum torque generated during knee extension |
at baseline, Week 8, and Week 13.
|
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Change in Knee Extension Total Work assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Total work performed during repeated maximal knee extension contractions. |
at baseline, Week 8, and Week 13.
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Change in Knee Flexion Peak Torque assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Knee Flexion measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
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Change in Knee Flexion Total Work assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Knee Flexion contractions |
at baseline, Week 8, and Week 13
|
|
Change in Shoulder Flexion Peak Torque assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Shoulder Flexion, measured at a preset angular velocity. |
at baseline, Week 8, and Week 13
|
|
Change in Shoulder Flexion Total Work assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Shoulder Flexion contractions |
at baseline, Week 8, and Week 13
|
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Change in Shoulder Abduction Peak Torque assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Shoulder Abduction , measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
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Change in Shoulder Abduction Total Work assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Shoulder Abduction contractions |
at baseline, Week 8, and Week 13
|
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Change in Elbow Extension Peak Torque assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Elbow Extension, measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
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Change in Elbow Extension Total Work assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Elbow Extension contractions |
at baseline, Week 8, and Week 13
|
|
Change in Elbow Flexion Peak Torque assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Elbow Flexion, measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
|
Change in Elbow Flexion Total Work assessed by Isokinetic Dynamometry
Periodo de tiempo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Elbow Flexion contractions |
at baseline, Week 8, and Week 13
|
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Change in Rhythmic Weight Shift (RWS) Score assessed by Computerized Dynamic Posturography
Periodo de tiempo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Score assessed by Computerized Dynamic Posturography
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Sensory Organization Test (SOT) Composite Score assessed by Computerized Dynamic Posturography
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
|
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Change in Motor Control Test (MCT) Latency assessed by Computerized Dynamic Posturography
Periodo de tiempo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Limits of Stability (LOS) Score assessed by Computerized Dynamic Posturography
Periodo de tiempo: at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Waist-to-Hip Ratio
Periodo de tiempo: at baseline and Week 13.
|
Ratio of waist circumference to hip circumference |
at baseline and Week 13.
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Change in Center of Mass Sway Amplitude during Baduanjin Exercise assessed by 3D Motion Capture
Periodo de tiempo: at baseline and Week 13
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Magnitude of anteroposterior and mediolateral displacement of the body's center of mass during static postures of Baduanjin, analyzed using a markerless 3D motion capture system |
at baseline and Week 13
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Change in Joint Range of Motion during Baduanjin Exercise assessed by 3D Motion Capture
Periodo de tiempo: at baseline and Week 13
|
Angular displacement of primary joints during the performance of Baduanjin movements, analyzed using a markerless 3D motion capture system. |
at baseline and Week 13
|
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Change in Glycemic Control Biomarkers
Periodo de tiempo: at baseline and Week 13.
|
Fasting venous blood samples will be analyzed for indicators of glucose metabolism, such as glycated hemoglobin (HbA1c) and fasting insulin. |
at baseline and Week 13.
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Change in Lipid Profile
Periodo de tiempo: at baseline and Week 13.
|
Fasting venous blood samples will be analyzed for indicators of lipid metabolism, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). |
at baseline and Week 13.
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Change in Inflammatory and Neurotrophic Biomarkers
Periodo de tiempo: at baseline and Week 13.
|
Fasting venous blood samples will be analyzed for inflammatory markers (e.g., high-sensitivity C-reactive protein [hs-CRP], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]) and brain-derived neurotrophic factor (BDNF). |
at baseline and Week 13.
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Baduanjin Movement Quality Score assessed by Blinded Expert Review (100-point scale)
Periodo de tiempo: at Week 13
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Score assessed by blinded experts using a standardized 100-point scoring rubric. Scores range from 0 to 100, with a higher score indicating better movement quality. |
at Week 13
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Shoufa 2024-1-4061
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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