Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
TRACE
Randomised Control Trial of Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
1 other identifier
interventional
160
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2028
February 11, 2026
February 1, 2026
1.9 years
February 4, 2026
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (4)
MCCB Working Memory Domain change (LNS + WMS III Spatial Span domain T score) baseline to Week 6.
6 weeks
MCCB Attention/Vigilance Domain change (CPT IP domain T score) baseline to Week 6.
6 weeks
Changes of negative symptoms measured with SANS from baseline to week 6
6 weeks
Durability of changes of negative symptoms relative to baseline and week 6
18 weeks
Other Outcomes (5)
Durability: MCCB Overall Composite and key domains at 3 months post intervention (Week 18) relative to baseline and Week 6.
18 weeks total
Changes of social functioning measured with SOFAS from baseline to 18 weeks
18 weeks
Durability: MCCB Overall Composite and key domains at 6 months post intervention (Week 24) relative to baseline and Week 6 and week 18
24
- +2 more other outcomes
Study Arms (4)
Arm 1: Aerobic Exercise + Active tDCS
EXPERIMENTAL* Intervention 1 (Behavioral): Aerobic exercise * Intervention 2 (Device): Active tDCS
Arm 2: Aerobic Exercise + Sham tDCS
ACTIVE COMPARATOR* Intervention 1 (Behavioral): Aerobic exercise * Intervention 2 (Device): Sham tDCS
Arm 3: Stretching/Education + Active tDCS
ACTIVE COMPARATOR* Intervention 1 (Behavioral): Stretching/education control * Intervention 2 (Device): Active tDCS
Arm 4: Stretching/Education + Sham tDCS
SHAM COMPARATOR* Intervention 1 (Behavioral): Stretching/education control * Intervention 2 (Device): Sham tDCS
Interventions
* 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.
* 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.
* 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
• Same montage; ramp up then off (device standard sham) to mimic cutaneous sensations.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kit Wa Chanlead
Study Sites (1)
The University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kit Wa Chan, MD
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 11, 2026
Study Start
February 23, 2026
Primary Completion (Estimated)
January 30, 2028
Study Completion (Estimated)
January 30, 2028
Last Updated
February 11, 2026
Record last verified: 2026-02