title: FitForLife: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Psychosis is a serious mental illness that typically emerges during early adulthood. The disorder is characterized by inactivity, cognitive deficits and the need for ongoing support. Regular exercise has mood enhancing and anxiolytic effects that could benefit this patient group. To date, few studies have examined the effects of prescribed exercise on autonomy, health and cognitive functioning in psychosis.
  
  
  METHODS
  This is a single-center, randomized controlled trial (RCT) with a 3-month follow-up. Usual care plus a 12-week supervised exercise program will be compared to usual outpatient care alone. The primary outcome will be patient autonomy measured by the Camberwell Assessment of Need (CAN) schedule - clinician rated. Secondary outcomes include cardiovascular risk factors, cognitive functioning, substance abuse, body awareness, depression and mood state. Changes in inflammatory markers and microbiotica will be explored. The feasibility of using patients as exercise trainers will also be assessed.
  
  
  CONCLUSIONS
  The treatment potential for exercise in psychosis is large because most individuals with the disorder are young and inactive. The study is one of the first to comprehensively assess the effects of regular exercise in young adults with psychosis. Sessions will be closely supervised and adjusted to meet patient needs. Both the feasibility and treatment effects of exercise interventions in psychosis will be discussed.
  
  
  BACKGROUND
  German Clinical Trials Register DRKS00008991 7 August 2015.
authors.affiliation: Division of Epidemiology and Public Health Intervention Research (EPHIR), Department of Public Health Sciences, Karolinska Institutet, Solna, 171 77, Sweden. Yvonne.forsell@ki.se.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Forsell
authors.affiliation: Division of Epidemiology and Public Health Intervention Research (EPHIR), Department of Public Health Sciences, Karolinska Institutet, Solna, 171 77, Sweden. Mats.hallgren@ki.se.
authors.forename: Mats
authors.initials: M
authors.lastname: Hallgren
authors.affiliation: Midhagen Psychiatric Outpatient Clinic, Sankt Göransgatan 126, Stockholm, 112 45, Sweden. Maria.mattson@sll.se.
authors.forename: Maria
authors.initials: M
authors.lastname: Mattson
authors.affiliation: The Swedish School of Sport and Health Sciences, Box 5626, Stockholm, 114 86, Sweden. Orjan.ekblom@gih.se.
authors.forename: Orjan
authors.initials: O
authors.lastname: Ekblom
authors.affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet, Solna, 171 77, Sweden. Catharina.lavebratt@ki.se.
authors.forename: Catharina
authors.initials: C
authors.lastname: Lavebratt
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect; D000367:Age Factors; D002985:Clinical Protocols; D003071:Cognition; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D026684:Personal Autonomy; D010809:Physical Fitness; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D012307:Risk Factors; D057185:Sedentary Behavior; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult