SchizophreniaNCT07745140
The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia
A study testing Aerobic exercise and Active tDCS in people with Schizophrenia and Cognitive Functions, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Cognitive Functions
- What is being tested?
- Aerobic exercise and Active tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Schizophrenia, Cognitive Functions
- Being tested
- Aerobic exercise, Active tDCS, Sham tDCS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
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 tDCSDevice
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.
Sham tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS and aerobic exercise | Active comparator | Not described Receives: Behavioral: Aerobic exercise; Device: Active tDCS |
| Sham tDCS and aerobic exercise | Sham comparator | Not described Receives: Behavioral: Aerobic exercise; Device: Sham tDCS |
| Waitlist control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hong Kong List Learning Test (HKLLT)
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.
Measured: Baseline and after the 6-week interventions
Secondary outcomes (10)
Rapid Visual Information Processing (RVP)
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.
Measured: Baseline and after the 6-week interventions
Digit Span (DGS)
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.
Measured: Baseline and after the 6-week interventions
The Verbal Fluency Test (VFT)
A measure of executive function. Participants have to name as many animals as possible in 60 seconds.
Measured: Baseline and after the 6-week interventions
6-Minute Walking Test
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.
Measured: Baseline and after the 6-week interventions
The Fatigue Assessment Scale (FAS)
A 10-item self-report instrument that evaluates fatigue symptoms.
Measured: Baseline and after the 6-week interventions
The sit-and-reach test
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.
Measured: Baseline and after the 6-week interventions
Standing Balance Test
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.
Measured: Baseline and after the 6-week interventions
Positive and Negative Syndrome Scale (PANSS)
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.
Measured: Baseline and after the 6-week interventions
Calgary Depression Scale (CDS)
A 9-item scale to evaluate depression, rated from 0 to 3.
Measured: Baseline and after the 6-week interventions
Magnetic Resonance Imaging (MRI)
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.
Measured: Baseline and after the 6-week interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN Jingxia Jessie, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745140
- Sponsor's protocol ID
- P0048824
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07745140
- Acronym / sponsor ID
- P0048824
- Conditions
- Schizophrenia, Cognitive Functions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tDCS and aerobic exercise | Active comparator | Behavioral: Aerobic exercise, Device: Active tDCS |
| Sham tDCS and aerobic exercise | Sham comparator | Behavioral: Aerobic exercise, Device: Sham tDCS |
| Waitlist control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAerobic 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. | Behavioural | Active tDCS and aerobic exercise, Sham tDCS and aerobic exercise |
| Active tDCSActive 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. | Device | Active tDCS and aerobic exercise |
| Sham tDCSSham 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. | Device | Sham tDCS and aerobic exercise |
Primary outcome
Hong Kong List Learning Test (HKLLT)
Time frame: Baseline and after the 6-week interventions
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.
10 secondary outcomes
Rapid Visual Information Processing (RVP)
Time frame: Baseline and after the 6-week interventions
Digit Span (DGS)
Time frame: Baseline and after the 6-week interventions
The Verbal Fluency Test (VFT)
Time frame: Baseline and after the 6-week interventions
6-Minute Walking Test
Time frame: Baseline and after the 6-week interventions
The Fatigue Assessment Scale (FAS)
Time frame: Baseline and after the 6-week interventions
The sit-and-reach test
Time frame: Baseline and after the 6-week interventions
Standing Balance Test
Time frame: Baseline and after the 6-week interventions
Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline and after the 6-week interventions
Calgary Depression Scale (CDS)
Time frame: Baseline and after the 6-week interventions
Magnetic Resonance Imaging (MRI)
Time frame: Baseline and after the 6-week interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Active tDCS in people with Schizophrenia and Cognitive Functions, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Jessie LIN (+852 2766 6718, jx-jessie.lin@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hong Kong List Learning Test (HKLLT) (time frame: Baseline and after the 6-week interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.