The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia
30 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
66
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Prof. Jessie LIN
- Numero di telefono: +852 2766 6718
- Email: jx-jessie.lin@polyu.edu.hk
Luoghi di studio
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- The Hong Kong Polytechnic University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Gruppo di controllo della lista d'attesa
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Comparatore attivo: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hong Kong List Learning Test (HKLLT)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rapid Visual Information Processing (RVP)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
30 giugno 2028
Completamento dello studio (Stimato)
31 dicembre 2028
Date di iscrizione allo studio
Primo inviato
30 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
30 luglio 2026
Primo Inserito (Effettivo)
4 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P0048824
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .