SchizophreniaTRACENCT07404319
Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
A study testing Aerobic Exercise and Active tDCS in people with Schizophrenia and Treatment Resistant Schizophrenia, run by Kit Wa Chan at 1 site in Hong Kong.
Trial summary
Cognitive impairment is a major determinant of disability in schizophrenia. Aerobic exercise improves global cognition in schizophrenia, particularly working memory and attention/vigilance. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Treatment Resistant Schizophrenia, Cognitive Impairment
- 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
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Feb 2026to 30 Jan 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM 5 schizophrenia-spectrum disorders
- Treatment resistant schizophrenia: inadequate response to ≥2 antipsychotics of adequate dose/duration
- Clinically stable ≥4 weeks
- Able to provide informed consent
Who cannot join
- Neurological disorder (e.g., epilepsy, stroke) or significant head injury
- Implanted electronic devices / contraindications to tDCS; scalp lesions at electrode sites
- Medical contraindications to moderate aerobic exercise
- Substance dependence within 3 months (except nicotine)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Kit Wa Chan, MD, 852-22554489, kwsherry@hku.hk
Yifan Chen, PhD, 852-22554486, yifchen@hku.hk
About this study
Official title: Randomised Control Trial of Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
Cognitive impairment is a major determinant of disability in schizophrenia. Aerobic exercise improves global cognition in schizophrenia, particularly working memory and attention/vigilance. Transcranial direct current stimulation (tDCS) targeting frontal regions has shown promise for cognitive deficits, including working memory improvements in some studies. This randomized 2×2 factorial trial will test the independent and combined effects of supervised aerobic exercise and prefrontal tDCS on cognition in treatment resistant schizophrenia, measured using the MATRICS Consensus Cognitive Battery (MCCB).
Read the detailed description
This is an individually randomized, sham controlled (tDCS), assessor blinded 2×2 factorial clinical trial comparing: (1) aerobic exercise vs stretching/education control and (2) active vs sham prefrontal tDCS. The factorial design enables estimation of the main effects of exercise and tDCS and their interaction (synergy/antagonism) in one trial.
Participants with treatment resistant schizophrenia (TRS) will complete 18 sessions over 6 weeks (3 sessions/week). Each session includes tDCS (active or sham) during the physical activity condition (aerobic exercise or stretching/education) to standardize timing and contact. Evidence suggests exercise associated cognitive gains relate to intervention dose and supervision. Noninvasive brain stimulation outcomes may vary with stimulation dose parameters, supporting a standardized protocol.
Cognition will be assessed using the MCCB, which evaluates seven cognitive domains relevant to schizophrenia and yields an Overall Composite T score. The primary endpoint is Week 6 (end of intervention), with durability assessed at 3 months post intervention (Week 18).
- Being tested
- Aerobic Exercise, Stretching/Education Control, Active tDCS, Sham tDCS
- Keywords
- tDCS, aerobic exercise, cognitive function, treatment-resistant schizophrenia
- Medical subject headings
- Schizophrenia, Schizophrenia, Treatment-Resistant, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
- Dose: 18 sessions over 6 weeks (3/week)
- Session duration: 45-60 minutes including warm up/cool down
- Intensity: Moderate (target 60-75% HRR or RPE 12-15)
- Mode: Aerobic dance
- Delivery: Supervised by qualified staff; HR/RPE logged each session
- Rationale: Exercise improves global cognition and domains such as working memory and attention/vigilance in schizophrenia; supervision/dose relate to effect size.
Stretching/Education ControlBehavioural
- Dose: 18 sessions over 6 weeks (3/week)
- Session duration: 45-60 minutes
- Intensity: Low (HR <40% HRR; RPE <10)
- Components: Stretching + standardized health education modules
- Purpose: Attention matched control to reduce contact/expectancy bias in non pharmacological trials.
Active tDCSDevice
- Montage: Anode F3 (left DLPFC), cathode Fp2 (right supraorbital)
- Intensity: 2.0 mA
- Duration: 20 minutes (30 s ramp up/down)
- Schedule: 18 sessions (one per visit)
- Rationale: Frontal tDCS protocols have shown promise for cognitive deficits and working memory in schizophrenia
Sham tDCSDevice
- Same montage; ramp up then off (device standard sham) to mimic cutaneous sensations.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Aerobic Exercise + Active tDCS | Experimental | * Intervention 1 (Behavioral): Aerobic exercise
* Intervention 2 (Device): Active tDCS Receives: Behavioral: Aerobic Exercise; Device: Active tDCS |
| Arm 2: Aerobic Exercise + Sham tDCS | Active comparator | * Intervention 1 (Behavioral): Aerobic exercise
* Intervention 2 (Device): Sham tDCS Receives: Behavioral: Aerobic Exercise; Device: Sham tDCS |
| Arm 3: Stretching/Education + Active tDCS | Active comparator | * Intervention 1 (Behavioral): Stretching/education control
* Intervention 2 (Device): Active tDCS Receives: Behavioral: Stretching/Education Control; Device: Active tDCS |
| Arm 4: Stretching/Education + Sham tDCS | Sham comparator | * Intervention 1 (Behavioral): Stretching/education control
* Intervention 2 (Device): Sham tDCS Receives: Behavioral: Stretching/Education Control; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCCB Overall Composite T score change from baseline (Week 0) to end of intervention (Week 6).
MCCB provides standardized domain and composite T scores for schizophrenia cognition research.
Measured: 6 weeks
Secondary outcomes (4)
MCCB Working Memory Domain change (LNS + WMS III Spatial Span domain T score) baseline to Week 6.
Working memory is responsive to exercise in schizophrenia meta-analysis and frequently targeted in frontal tDCS studies.
Measured: 6 weeks
MCCB Attention/Vigilance Domain change (CPT IP domain T score) baseline to Week 6.
Attention/vigilance improves with exercise in schizophrenia meta analysis; attention demanding performance may improve in some tDCS protocols.
Measured: 6 weeks
Changes of negative symptoms measured with SANS from baseline to week 6
Studies have shown effectiveness of exercise and tDCS on improvement of negative symptoms in patients with schizophrenia
Measured: 6 weeks
Durability of changes of negative symptoms relative to baseline and week 6
Evaluates the persistence of the improvement of negative symptoms
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start23 Feb 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 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.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kit Wa Chan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kit Wa Chan, The University of Hong Kong
- Investigators
- Kit Wa Chan, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404319
- Sponsor's protocol ID
- C7001-24Y
- Acronym
- TRACE
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing data will depend on funder. Further information will need to be checked and confirmed.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial of Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT07404319
- Acronym / sponsor ID
- TRACE / C7001-24Y
- Keywords
- tDCS, aerobic exercise, cognitive function, treatment-resistant schizophrenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kit Wa ChanUniversity, hospital or other
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 11 Feb 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.
Cognitive impairment is a major determinant of disability in schizophrenia. Aerobic exercise improves global cognition in schizophrenia, particularly working memory and attention/vigilance. Transcranial direct current stimulation (tDCS) targeting frontal regions has shown promise for cognitive deficits, including working memory improvements in some studies. This randomized 2×2 factorial trial will test the independent and combined effects of supervised aerobic exercise and prefrontal tDCS on cognition in treatment resistant schizophrenia, measured using the MATRICS Consensus Cognitive Battery (MCCB).
Detailed description
This is an individually randomized, sham controlled (tDCS), assessor blinded 2×2 factorial clinical trial comparing: (1) aerobic exercise vs stretching/education control and (2) active vs sham prefrontal tDCS. The factorial design enables estimation of the main effects of exercise and tDCS and their interaction (synergy/antagonism) in one trial.
Participants with treatment resistant schizophrenia (TRS) will complete 18 sessions over 6 weeks (3 sessions/week). Each session includes tDCS (active or sham) during the physical activity condition (aerobic exercise or stretching/education) to standardize timing and contact. Evidence suggests exercise associated cognitive gains relate to intervention dose and supervision. Noninvasive brain stimulation outcomes may vary with stimulation dose parameters, supporting a standardized protocol.
Cognition will be assessed using the MCCB, which evaluates seven cognitive domains relevant to schizophrenia and yields an Overall Composite T score. The primary endpoint is Week 6 (end of intervention), with durability assessed at 3 months post intervention (Week 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Aerobic Exercise + Active tDCS | Experimental | Behavioral: Aerobic Exercise, Device: Active tDCS* Intervention 1 (Behavioral): Aerobic exercise * Intervention 2 (Device): Active tDCS |
| Arm 2: Aerobic Exercise + Sham tDCS | Active comparator | Behavioral: Aerobic Exercise, Device: Sham tDCS* Intervention 1 (Behavioral): Aerobic exercise * Intervention 2 (Device): Sham tDCS |
| Arm 3: Stretching/Education + Active tDCS | Active comparator | Behavioral: Stretching/Education Control, Device: Active tDCS* Intervention 1 (Behavioral): Stretching/education control * Intervention 2 (Device): Active tDCS |
| Arm 4: Stretching/Education + Sham tDCS | Sham comparator | Behavioral: Stretching/Education Control, Device: Sham tDCS* Intervention 1 (Behavioral): Stretching/education control * Intervention 2 (Device): Sham tDCS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM 5 schizophrenia-spectrum disorders
- Treatment resistant schizophrenia: inadequate response to ≥2 antipsychotics of adequate dose/duration
- Clinically stable ≥4 weeks
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Neurological disorder (e.g., epilepsy, stroke) or significant head injury
- Implanted electronic devices / contraindications to tDCS; scalp lesions at electrode sites
- Medical contraindications to moderate aerobic exercise
- Substance dependence within 3 months (except nicotine)
- Pregnancy
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 Exercise* Dose: 18 sessions over 6 weeks (3/week) * Session duration: 45-60 minutes including warm up/cool down * Intensity: Moderate (target 60-75% HRR or RPE 12-15) * Mode: Aerobic dance * Delivery: Supervised by qualified staff; HR/RPE logged each session * Rationale: Exercise improves global cognition and domains such as working memory and attention/vigilance in schizophrenia; supervision/dose relate to effect size. | Behavioural | Arm 1: Aerobic Exercise + Active tDCS, Arm 2: Aerobic Exercise + Sham tDCS |
| Stretching/Education Control* Dose: 18 sessions over 6 weeks (3/week) * Session duration: 45-60 minutes * Intensity: Low (HR <40% HRR; RPE <10) * Components: Stretching + standardized health education modules * Purpose: Attention matched control to reduce contact/expectancy bias in non pharmacological trials. | Behavioural | Arm 3: Stretching/Education + Active tDCS, Arm 4: Stretching/Education + Sham tDCS |
| Active tDCS* Montage: Anode F3 (left DLPFC), cathode Fp2 (right supraorbital) * Intensity: 2.0 mA * Duration: 20 minutes (30 s ramp up/down) * Schedule: 18 sessions (one per visit) * Rationale: Frontal tDCS protocols have shown promise for cognitive deficits and working memory in schizophrenia | Device | Arm 1: Aerobic Exercise + Active tDCS, Arm 3: Stretching/Education + Active tDCS |
| Sham tDCS• Same montage; ramp up then off (device standard sham) to mimic cutaneous sensations. | Device | Arm 2: Aerobic Exercise + Sham tDCS, Arm 4: Stretching/Education + Sham tDCS |
Primary outcome
MCCB Overall Composite T score change from baseline (Week 0) to end of intervention (Week 6).
Time frame: 6 weeks
MCCB provides standardized domain and composite T scores for schizophrenia cognition research.
4 secondary outcomes
MCCB Working Memory Domain change (LNS + WMS III Spatial Span domain T score) baseline to Week 6.
Time frame: 6 weeks
MCCB Attention/Vigilance Domain change (CPT IP domain T score) baseline to Week 6.
Time frame: 6 weeks
Changes of negative symptoms measured with SANS from baseline to week 6
Time frame: 6 weeks
Durability of changes of negative symptoms relative to baseline and week 6
Time frame: 18 weeks
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 11 Feb 2026.
- Individual participant dataSharing planned: Undecided. Sharing data will depend on funder. Further information will need to be checked and confirmed.
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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.
Kit Wa Chan, MD principal investigator
The University of Hong Kong
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 Treatment Resistant Schizophrenia, run by Kit Wa Chan 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 4 inclusion and 5 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 11 Feb 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 Kit Wa Chan, MD (852-22554489, kwsherry@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCCB Overall Composite T score change from baseline (Week 0) to end of intervention (Week 6). (time frame: 6 weeks). 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 11 Feb 2026.