The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia
30 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
66
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Prof. Jessie LIN
- Número de telefone: +852 2766 6718
- E-mail: jx-jessie.lin@polyu.edu.hk
Locais de estudo
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- The Hong Kong Polytechnic University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Grupo de controle da lista de espera
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hong Kong List Learning Test (HKLLT)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Rapid Visual Information Processing (RVP)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
30 de junho de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
30 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de julho de 2026
Primeira postagem (Real)
4 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P0048824
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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Estuda um medicamento regulamentado pela FDA dos EUA
Não
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