Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic Exercise, Stretching/Education Control, Active tDCS, Sham tDCS.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Treatment Resistant Schizophrenia, Cognitive Impairment. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomised Control Trial of Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia
Overview
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).
Interventions
- Behavioral 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. - Behavioral 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. - Device 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 Sham tDCS
• Same montage; ramp up then off (device standard sham) to mimic cutaneous sensations.
Primary outcome measures
- MCCB Overall Composite T score change from baseline (Week 0) to end of intervention (Week 6). [Time frame: 6 weeks]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07404319 · C7001-24Y