Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia

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).

Conditions

• Schizophrenia
• Treatment Resistant Schizophrenia
• Cognitive Impairment

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.

Sponsors & Collaborators

• Kit Wa Chan

  lead OTHER

Principal Investigators

• Kit Wa Chan, MD · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-23

Primary Completion

2028-01-30

Completion

2028-01-30

Countries

• Hong Kong

Study Locations