Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome (START GAAIMS): A Feasibility Study Protocol

<ns3:p>Background Individuals with psychotic disorders face a 20-year mortality gap compared to the general population, largely driven by cardiovascular disease and metabolic syndrome. Antipsychotic medications, while essential, exacerbate this risk through rapid weight gain and metabolic dysregulation, particularly in the first three months of treatment. Resistance training improves body composition and metabolic health, particularly glucose regulation. Its effects on muscle strength and hypertrophy are enhanced by a caloric surplus that, in its absence, would otherwise lead to accumulation of adipose tissue. Its feasibility and efficacy in drug-naïve or minimally treated First-Episode Psychosis (FEP) patients has not been previously explored. Methods The START GAAIMS study is a multicentre, two-arm, crossover, randomised controlled feasibility trial. Forty adults (18–65 years) with FEP and &lt; 4 weeks of antipsychotic exposure will be recruited from services in Dublin and Cork. Participants will be randomised (1:1) to an Intervention Group (12-week supervised RT programme + Treatment as Usual [TAU]) or a Control Group (TAU only). After 12 weeks, the control group will crossover to receive the intervention. Outcome Measures The primary outcome is the feasibility of the trial design (recruitment, retention, adherence) and a preliminary estimate of the effect size for change in body fat percentage at 12 weeks. Secondary outcomes include muscular power, metabolic biomarkers (glucose, lipids, inflammatory markers), and psychiatric symptoms (BPRS). Discussion This study will determine preliminary measures of the effects of resistance training on body composition in people with FEP starting antipsychotic medication, as well as its feasibility and acceptability in this cohort. Findings will inform the design of a definitive RCT to establish RT as a standard co-treatment for metabolic health in early psychosis.</ns3:p>