The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia
30 de julio de 2026 actualizado por: LIN Jingxia Jessie, The Hong Kong Polytechnic University
Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled Trial
The study will investigate the (1) additive and synergistic effects of tDCS and aerobic exercise on cognitive function and clinical symptoms in schizophrenia, and (2) neurophysiological mechanisms (mediators) underlying these effects.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
66
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.
Estudio Contacto
- Nombre: Prof. Jessie LIN
- Número de teléfono: +852 2766 6718
- Correo electrónico: jx-jessie.lin@polyu.edu.hk
Ubicaciones de estudio
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- The Hong Kong Polytechnic University
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Schizophrenia spectrum disorders;
- Aged from 18 to 65.
- Chinese-speaking (to enable cognitive testing).
- Ability to understand the nature of the study and to give informed consent.
- Fewer than 10 hours of physical exercise in the previous 3 months.
Exclusion Criteria:
- Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise with mild-to-moderate intensity may be contraindicated).
- Comorbid diagnoses of organic brain syndrome, substance misuse, history of epilepsy or seizure, intellectual disability, significant head trauma, active suicidal ideation or self-harm behaviors.
- Known pregnancy, or other contraindication to tDCS or MRI (e.g., have a cardiac/heart pacemaker, brain aneurysm clips, any implanted metallic or electrical device, or any internal metal foreign objects).
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control de lista de espera
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Comparador activo: Active tDCS and aerobic exercise
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Aerobic exercise training will be conducted twice per week, over a period of 6 weeks, supervised by a well-trained facilitator.
Each 45-minute session consists of a warm-up (10 minutes), treadmill walking (15 minutes), stationary bike cycling (15 minutes), and cool-down stretching (5 minutes).
Heart rate will be monitored throughout training by a wearable device, and 60% of the maximum heart rate (roughly calculated by 220-age) should be maintained for at least 20 minutes during each session.
Participants may stop exercising at any time if they feel uncomfortable.
Active tDCS will be applied using a wearable stimulator (Liftid) at a constant stimulation intensity of 1.2 mA for 20 minutes.
The device has been designed for anodal stimulation targeting the dorsolateral prefrontal cortex (DLPFC) using the F3 (anode) to F4 (cathode) montages.
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Comparador falso: Sham tDCS and aerobic exercise
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Aerobic exercise training will be conducted twice per week, over a period of 6 weeks, supervised by a well-trained facilitator.
Each 45-minute session consists of a warm-up (10 minutes), treadmill walking (15 minutes), stationary bike cycling (15 minutes), and cool-down stretching (5 minutes).
Heart rate will be monitored throughout training by a wearable device, and 60% of the maximum heart rate (roughly calculated by 220-age) should be maintained for at least 20 minutes during each session.
Participants may stop exercising at any time if they feel uncomfortable.
Sham tDCS will be performed using the same device but without stimulation.
During the aerobic exercise training, all participants will wear the device, and a facilitator will turn on the stimulation for participants receiving a-tDCS+AE intervention, and pretend to turn on the stimulation for participants receiving s-tDCS+AE intervention after the first 10-minute warm-up section.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hong Kong List Learning Test (HKLLT)
Periodo de tiempo: Baseline and after the 6-week interventions
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A Chinese verbal memory test designed to assess the processes and organizational strategies involved in learning verbal information.
The test consists of two different 16-item two-character Chinese word lists, namely the random and blocked conditions.
Total learning score, short-term, and long-term memory will be recorded in both conditions.
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Baseline and after the 6-week interventions
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rapid Visual Information Processing (RVP)
Periodo de tiempo: Baseline and after the 6-week interventions
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A measure of sustained attention.
A white box is shown in the center of the screen, inside which digits from 2 to 9 appear in a pseudo-random order, at the rate of 100 digits per minute.
Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8).
When the participant sees the target sequence, they must respond by selecting the button in the center of the screen as quickly as possible.
The level of difficulty varies depending on whether the participant must watch for one- or three-target sequences at the same time.
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Baseline and after the 6-week interventions
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Digit Span (DGS)
Periodo de tiempo: Baseline and after the 6-week interventions
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A measure of verbal short-term and working memory.
The participant will hear a sequence of digits and will immediately be prompted to verbally repeat it.
If the participant responds correctly, the next trial presents a longer sequence.
The task terminates when participants respond incorrectly on three occasions at a span length.
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Baseline and after the 6-week interventions
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The Verbal Fluency Test (VFT)
Periodo de tiempo: Baseline and after the 6-week interventions
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A measure of executive function.
Participants have to name as many animals as possible in 60 seconds.
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Baseline and after the 6-week interventions
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6-Minute Walking Test
Periodo de tiempo: Baseline and after the 6-week interventions
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A sub-maximal exercise test to assess the aerobic capacity and endurance.
The subject has to walk as far as possible along a track for 6 minutes.
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Baseline and after the 6-week interventions
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The Fatigue Assessment Scale (FAS)
Periodo de tiempo: Baseline and after the 6-week interventions
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A 10-item self-report instrument that evaluates fatigue symptoms.
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Baseline and after the 6-week interventions
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The sit-and-reach test
Periodo de tiempo: Baseline and after the 6-week interventions
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A common measure of flexibility, specifically assessing the lower back and hamstring muscles.
The subject is seated against the wall, arms outstretched towards the box.
A sliding ruler is used to measure the position of the fingertips.
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Baseline and after the 6-week interventions
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Standing Balance Test
Periodo de tiempo: Baseline and after the 6-week interventions
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Give the subject a minute to practice their balancing before starting the test.
Then ask the person to stand on one foot for as long as possible.
The total length of time a person can stay in the balance position will be recorded.
The timing stops when the elevated foot touches the ground or the person hops or otherwise loses their balance position.
The test will be conducted with the person having their arms on their waist.
Repeat the test on the other leg.
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Baseline and after the 6-week interventions
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Positive and Negative Syndrome Scale (PANSS)
Periodo de tiempo: Baseline and after the 6-week interventions
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Measuring symptom severity of patients with schizophrenia.
It contains 33 items across three subscales (Positive, Negative, and General), rated from 1-7 on each item based on clinical interviews as well as reports from family members or primary care hospital workers.
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Baseline and after the 6-week interventions
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Calgary Depression Scale (CDS)
Periodo de tiempo: Baseline and after the 6-week interventions
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A 9-item scale to evaluate depression, rated from 0 to 3.
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Baseline and after the 6-week interventions
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Magnetic Resonance Imaging (MRI)
Periodo de tiempo: Baseline and after the 6-week interventions
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Both structural and resting-state functional MRI will be acquired on a 3 Tesla MRI scanner (Prisma, Siemens, Germany).
For registration purposes, high-resolution T1-weighted anatomical images will be acquired during 3-D MP-RAGE (parameters: slice thickness=1mm, echo time=3.26ms,
repetition time=2250ms, inversion time=900ms, flip angle=9°, in-plane voxel size 1×1 mm2, acquisition time=5 minutes).
Functional scans (resting state) will use a gradient-echo echo-planar imaging (parameters: repetition/echo time=800/37ms; flip angle=52°; field of view=208mm; 2mm isotropic [no gap]; no. of dynamics=380, acquisition time=5 minutes).
The resting fMRI scan will be repeated for 5 times with a total acquisition time of 25 minutes.
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Baseline and after the 6-week interventions
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
1 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2026
Publicado por primera vez (Actual)
4 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P0048824
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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