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

Sponsor
Kit Wa Chan
Study ID
NCT07404319
Status
Not Yet Recruiting

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Conditions

  • Cognitive Impairment
  • Schizophrenia
  • Treatment Resistant Schizophrenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Aerobic Exercise — BEHAVIORAL
    * 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 Control — BEHAVIORAL
    * 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 tDCS — DEVICE
    * 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 tDCS — DEVICE
    • Same montage; ramp up then off (device standard sham) to mimic cutaneous sensations.

Study Details

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).

Key Dates

First listed
Feb 11, 2026
Start date
Feb 23, 2026
Status verified
Feb 2026
Primary completion
Jan 30, 2028
Completion
Jan 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Aerobic Exercise + Active tDCS
    * Intervention 1 (Behavioral): Aerobic exercise * Intervention 2 (Device): Active tDCS
  • Active Comparator: Arm 2: Aerobic Exercise + Sham tDCS
    * Intervention 1 (Behavioral): Aerobic exercise * Intervention 2 (Device): Sham tDCS
  • Active Comparator: Arm 3: Stretching/Education + Active tDCS
    * Intervention 1 (Behavioral): Stretching/education control * Intervention 2 (Device): Active tDCS
  • Sham Comparator: Arm 4: Stretching/Education + Sham tDCS
    * Intervention 1 (Behavioral): Stretching/education control * Intervention 2 (Device): Sham tDCS

Primary Outcome Measure

MCCB Overall Composite T score change from baseline (Week 0) to end of intervention (Week 6). [ Time Frame: 6 weeks ]

Central Contacts

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