- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04896671
Physical Exercise Training to Enhance Executive and Social Functions
Neural Mechanism of Physical Exercise in Enhancing Executive and Social Functions in Adolescents
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Executive functions (EF) refer to goal-directed cognitive processes consisting of three major components including cognitive flexibility (mental flexibility), inhibition (inhibitory control) and working memory. These components interact with each other and play a crucial role in a range of life outcomes including mental and physical health, school and job success and marital harmony. In addition, higher EF is associated with better problem solving, reasoning and planning skills as well as social functions.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterised by social communication and interaction impairments, as well as restricted and repetitive patterns of behavior. Individuals with ASD have EF impairments which are linked to the restricted and repetitive behaviors that characterise this condition. The prevalence of ASD is increasing with as many as 1 in 68 individuals, which further augments the burden to the ASD individuals, their families and society. Hence, it is essential to investigate the underlying mechanism of ASD and design a cost-effective training that can be widely adopted in the community to reduce impairments arising from ASD symptoms.
Importantly, ASD traits occur on a continuum, and increasingly there is recognition of a broader autism phenotype (BAP) in those that show sub-clinical symptoms. Similarly, these individuals also show impairments in executive function and social functions, making this group an important target for the development and implementation of interventions. As such, we can deliver appropriate training at an earlier stage to prevent associated impairments in those with ASD traits. Therefore, instead of ASD, the present study examines the individuals with BAP.
Given EF impairments along with social function deficits are found in the sub-clinical individuals with BAP, is the training pertaining to ASD applicable to these individuals? In prior literature, physical exercise (PE) has been proved to enhance EF and social functions. For instance, regular PE can enhance cerebral blood flow and increase the formation of new blood vessels in a number of brain regions that are involved in EF and social functions. More specifically, PE is shown to enhance the performance of EF in healthy children and pre-adolescents and those with ASD. For example, it was found that PE including jogging significantly decreased the repetitive and off-task behaviors and the level of aggression in individuals with ASD. Nevertheless, although PE is shown to be beneficial to reduce the symptoms and EF as well as social impairments in ASD, whether it produces the same positive outcomes in the non-clinical individuals. To address the research questions listed above, this proposed study aims to investigate whether PE training enhances the EF and social functions in the adolescents with BAP.
Although the benefits of physical exercise have been studied in the ASD, BAP is under studied in prior literature. This proposed study will extend from the current literature to investigate the non-clinical group who have autistic traits with a longitudinal and randomized controlled trial design (RCT). The findings of this proposed study have multiple levels of significance and implications. For instance, if the hypotheses are supported, the PE training which is more cost-effective than psychotherapy in treating EF and social functioning deficits and associated impairments can be promoted to school settings. Ultimately, it can be incorporated to the curriculum of the primary and secondary schools to reduce BAP and associated impairments in the adolescents. Secondly, by examining those with sub- clinical symptoms, this research will contribute to early trainings approaches for the condition. Lastly, this proposed study can also help promote physical activities among adolescents which can further decrease mental and health issues in the local context.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hong Kong, Hong Kong, 00000
- The Hong Kong Polytechnic University
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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:
- Age ranges from 7 to 20
- Studying at one of the local schools
- Have never been diagnosed with ASD or any other disorder listed in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- Are not currently under any psychiatric medications or therapies
Exclusion Criteria:
- Have been diagnosed with ASD or any other disorder listed in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- Are currently under any psychiatric medications or therapies
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention group
Each participant joins a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes.
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Participants in the intervention group join a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes.
In each session, every participant will be trained to run for 30 minutes on a treadmill.
According to Exercise and Sports Science Australia (ESSA) exercise intensity guidelines, the intensity of running is suggested to be moderate and vigorous (alternating between the two) in this study.
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Sin intervención: Waitlist control group
They receive no treatments.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Demographics
Periodo de tiempo: Before intervention (baseline)
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A simple demographic questionnaire will be used to gather participants personal information, including age, gender, current medication or therapy, and medical history of the participant and his/her family members.
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Before intervention (baseline)
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Change from baseline autistic traits at 6 weeks
Periodo de tiempo: baseline and 6- week follow up
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The Autism-Spectrum Quotient-Adolescent Version (AQ-Adolescent; Baron-Cohen et al., 2006) and related self-report scales will be used to measure ASD traits.
The AQ- adolescent is a self-report questionnaire comprising of 50 items assessing five areas, namely social, attention switching, attention to detail, communication and imagination.
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baseline and 6- week follow up
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Change from baseline executive functions at 6 weeks
Periodo de tiempo: baseline and 6- week follow up
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EF and social functions will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
The CANTAB is a computerized test battery targeting multiple neuropsychological functions.
This battery includes Reaction Time, Paired Associates Learning, Spatial Working Memory, One Touch Stockings of Cambridge, Multitasking Test, and Emotion Recognition Task.
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baseline and 6- week follow up
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Change from baseline psychological resilience at 6 weeks
Periodo de tiempo: baseline and 6- week follow up
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Participant's psychological resilience will be measured by 10-item Connor-Davidson Resilience Scale (CD-RISC).
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baseline and 6- week follow up
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Change from baseline schizotypal personality traits at 6 weeks
Periodo de tiempo: baseline and 6- week follow up
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Schizotypal Personality Questionnaire will be used to measure schizotypal personality traits.
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baseline and 6- week follow up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline aggression at 6 weeks
Periodo de tiempo: baseline and 6- week follow up
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Reactive and Proactive Aggression Questionnaire will be used to measure aggression in the participants.
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baseline and 6- week follow up
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Change from baseline empathy at 6 weeks
Periodo de tiempo: baseline and 6- week follow up
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Cognitive, Affective and Somatic Empathy Scale (CASES) will be used to measure empathy.
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baseline and 6- week follow up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bess Yin-Hung Lam, PhD, The University of Hong Kong
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- HSEARS20190311003
Información sobre medicamentos y dispositivos, documentos del estudio
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