- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07839975
A Study on the Evaluation of College Students' Athletic Fitness Using a Data Model Integrating Traditional Chinese Medicine Constitution Classification and Wrist Wearable Devices
To establish a multidimensional assessment system for college students' motor function and construct a quantitative model. Kinematic and physiological parameters will be collected using a wrist-worn wearable device, combined with active movement task testing, anthropometric measurements, and other relevant health information, to comprehensively assess college students' motor function characteristics, including balance, coordination, endurance, and explosive power.Secondary Objective: To explore the combined effects of motor ability, lifestyle, and traditional Chinese medicine constitution.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Primary Objective The primary objective of this study is to establish a multidimensional assessment system for motor function in college students and to construct a quantitative assessment model. During standardized active movement tasks, kinematic and physiological parameters will be collected using a wrist-worn wearable device. These data will be combined with the results of motor function tests, anthropometric measurements, and other relevant health information to comprehensively evaluate the motor function characteristics of college students.
The assessment will cover multiple dimensions of motor function, including balance, coordination, endurance, and explosive power. By integrating wearable device-derived parameters with conventional motor function assessment indicators, the study aims to identify key indicators associated with different dimensions of motor ability and to construct a quantitative model for the comprehensive assessment of motor function in college students.
Secondary Objective The secondary objective is to explore the associations among motor ability, lifestyle characteristics, and traditional Chinese medicine (TCM) constitution in college students. Information on lifestyle-related factors, including physical activity, exercise habits, sleep, sedentary behavior, and other relevant health behaviors, as well as TCM constitution characteristics, will be collected.
These data will be analyzed together with multidimensional motor function indicators to investigate the relationships between lifestyle factors, TCM constitution, and different aspects of motor function, and to explore their combined associations with overall motor ability in college students.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chao Chen
- Número de teléfono: 86+13580348819
- Correo electrónico: chenchao@smu.edu.cn
Ubicaciones de estudio
-
-
Guangdong
-
Guangzhou, Guangdong, Porcelana, 510515
- Reclutamiento
- Nanfang Hospital, Southern Medical University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Normal individuals aged 18-25 years.
Descripción
Inclusion Criteria:
- Agree to participate in the study and voluntarily sign the informed consent form;
- Be a university student aged 18-25, gender not limited;
- Be in generally good physical condition and able to complete the exercise tests required for this study;
- Be able to wear the wrist-worn device as required by the study and cooperate in completing questionnaires, physical fitness assessments, and related data collection;
- Have not experienced any acute injuries, serious illnesses, or hospitalizations that would affect daily activities or exercise tests within the past month.
Exclusion Criteria:
- Individuals with severe cardiovascular disease, motor dysfunction, or cognitive impairment.
- Individuals with recent severe trauma or hospitalization who are unsuitable for exercise testing.
- Individuals with a history of congenital spinal deformities or severe flat feet, or other diseases affecting muscles, nerves, or bones.
- Individuals deemed unsuitable for participation in this study by the researchers.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Wrist-worn IMU- and PPG-derived Kinematic and Physiological Parameters, Including Step Frequency, Peak Acceleration, and Heart Rate Variability
Periodo de tiempo: Baseline
|
Kinematic and physiological parameters will be collected using a wrist-worn device equipped with an inertial measurement unit (IMU) and photoplethysmography (PPG) sensors at a sampling frequency of 200 Hz. The wearable-derived measures will include step frequency, peak acceleration, and heart rate variability indices. Data will be collected during standardized motor tasks, including 10-m walking, paper-ball throwing, a visual stimulus-tapping reaction task, single-leg standing, and plank support, as well as during 24-hour continuous monitoring under free-living conditions. |
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Height and Body Weight
Periodo de tiempo: Baseline
|
Height (cm) and body weight (kg) will be measured using a stadiometer and calibrated scale, respectively. |
Baseline
|
|
Demographic Characteristics
Periodo de tiempo: Baseline
|
Demographic information, including age and sex, will be collected using a questionnaire. |
Baseline
|
|
Traditional Chinese Medicine Constitution Classification
Periodo de tiempo: Baseline
|
Traditional Chinese Medicine constitution type will be assessed using the Wang Qi Traditional Chinese Medicine Constitution Questionnaire. Participants will be classified into constitution categories according to the questionnaire scoring criteria. |
Baseline
|
|
Tongue Image Features
Periodo de tiempo: Baseline
|
Digital tongue images will be collected under standardized conditions. Tongue image characteristics, including tongue color, tongue shape, and tongue coating features, will be extracted for analysis. |
Baseline
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Nawaratne R, Alahakoon D, De Silva D, O'Halloran PD, Montoye AH, Staley K, Nicholson M, Kingsley MI. Deep Learning to Predict Energy Expenditure and Activity Intensity in Free Living Conditions using Wrist-specific Accelerometry. J Sports Sci. 2021 Mar;39(6):683-690. doi: 10.1080/02640414.2020.1841394. Epub 2020 Oct 30.
- Culverhouse J, Hillsdon M, Metcalf B, Nunns M, Lear R, Brailey G, Pulsford R. Associations between device-measured physical activity and performance-based physical function outcomes in adults: a systematic review and meta-analysis. BMJ Public Health. 2023 Oct 30;1(1):e100000. doi: 10.1136/bmjph-2023-100000. eCollection 2023 Nov.
- Babu M, Lautman Z, Lin X, Sobota MHB, Snyder MP. Wearable Devices: Implications for Precision Medicine and the Future of Health Care. Annu Rev Med. 2024 Jan 29;75:401-415. doi: 10.1146/annurev-med-052422-020437. Epub 2023 Nov 20.
- Zhang W, Xiong K, Zhu C, Evans R, Zhou L, Podrini C. Promoting child and adolescent health through wearable technology: A systematic review. Digit Health. 2024 Jun 11;10:20552076241260507. doi: 10.1177/20552076241260507. eCollection 2024 Jan-Dec.
- Scott JJ, Rowlands AV, Cliff DP, Morgan PJ, Plotnikoff RC, Lubans DR. Comparability and feasibility of wrist- and hip-worn accelerometers in free-living adolescents. J Sci Med Sport. 2017 Dec;20(12):1101-1106. doi: 10.1016/j.jsams.2017.04.017. Epub 2017 Apr 21.
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
Otros números de identificación del estudio
- NFEC-2026-414
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared at this time due to concerns regarding participant privacy and confidentiality.
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.
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. .