Abstract
BackgroundThe aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis.MethodsTwenty-five patients with first-episode psychosis took part in a two-arm randomised feasibility trial. They were individually randomised (1:1) via a computer-generated randomisation sequence and allocated to either an exercise intervention group (INT) or a control group (CON). Patients allocated to INT completed a physical exercise training programme at moderate-to-vigorous intensity, 1 h three times weekly for 8 weeks. CON patients were encouraged to continue their usual level of activity and were offered the training programme after 8 weeks. Primary outcomes included screening rate, recruitment rate, retention rate, attendance and adverse events. Secondary outcomes included heart rate response during training, cardiovascular health (VO2max, resting heart rate, blood pressure), body composition (muscle mass, fat percentage), muscle strength (sit-to-stand, grip strength, jump height) and balance.ResultsRecruitment lasted 6 weeks and 86 out of 324 patients (27%) were screened, 71 of whom (83%) were deemed eligible. Twenty-five (35%) accepted inclusion (mean age 25.5; mean body mass index 25.1) and were subsequently randomised (INT = 13, CON = 12). Retention of patients was 76% and 52% at the 8-week and 16-week follow-up, respectively. Attendance was 43% (min. 9%, max. 96%). No significant changes were observed between groups in secondary physiological outcome measures.ConclusionsFeasibility was challenged by limited recruitment and retention rates, suggesting that modifications are required if a large-scale randomised controlled trial is to be conducted. Recommendations for modifications are presented and discussed.Trial registrationClinicaltrials.gov, NCT03409393. Retrospectively registered.
Highlights
The aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis
With the aim to investigate whether it was possible to recruit and retain patients with early psychosis for a supervised, gym-based exercise training programme, we developed and conducted a feasibility trial called COPUS
Despite early psychosis being proposed as the optimal phase for using exercise [14], the current study is among the first randomised controlled trials to assess the feasibility of an exercise training programme compared to usual care in patients with first-episode psychosis undergoing specialised early intervention
Summary
The aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis. The clinical symptoms usually manifest in early adult life [1, 2], and many patients experience persistent difficulties. Previous research indicates that specialised interventions that take place soon after the onset of the first episode of psychosis are associated with reduced symptoms and improved overall functioning [3]. Specialised early intervention teams constitute standard treatment for first-episode psychosis in many developed countries [3,4,5]. Patients with schizophrenia have a two- to three-fold higher risk of cardiovascular diseases compared to the general population [8], contributing to a premature mortality of 15–20 years observed in people with schizophrenia [9,10,11] and an increasing mortality gap [12]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
