protocolSection identificationModule nctId: NCT06313918, orgStudyIdInfo id: REK nr. 428096, briefTitle: Exercise Therapy in Mental Disorders-study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2026-09-26, completionDateStruct date: 2026-09-26, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective., conditionsModule conditions: Schizophrenia and Related Disorders, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open label, two-arm, parallel group, randomised trial, to compare standard and short HIT during 26 weeks of supervised exercise. The group will receive comprehensive follow-up to be able to carry out the 26 weeks exercise intervention program. Outcome measures will be taken at; baseline (T0), 4 weeks (T1), 12 weeks (T2), 26 weeks (T3), and 52 weeks (T4) post randomisation., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: High intensity training (HIT), outcomesModule primaryOutcomes measure: Adherence, secondaryOutcomes measure: Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score, secondaryOutcomes measure: Change of the Calgary Depression Scale in Schizophrenia score, secondaryOutcomes measure: Change of the Clinical Global Impression (CGI) score, secondaryOutcomes measure: Change of the Global Assessment of Funtioning (GAF) score, secondaryOutcomes measure: Change of quality of life (QOL10) score, secondaryOutcomes measure: Change of the International Physical Activity Questionaire (IPAQ) score, secondaryOutcomes measure: Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score, secondaryOutcomes measure: Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score, secondaryOutcomes measure: Change of the Difficulties in Emotion Regulation (DERS) score, secondaryOutcomes measure: Change in heart rate (beats per minute), secondaryOutcomes measure: Change of maximal oxygene extraction (VO2max), secondaryOutcomes measure: Change of level of inflammatory markers in blood, secondaryOutcomes measure: Change of body weight (kilograms), secondaryOutcomes measure: Change of hip- and waist circumference (centimetres), secondaryOutcomes measure: Change of serum glucose (mmol/L), secondaryOutcomes measure: Change of serum cholesterols (mmol/L), secondaryOutcomes measure: Change of serum triglyceride (mmol/L), secondaryOutcomes measure: Change of gene expression, secondaryOutcomes measure: Change of methylation of DNA, secondaryOutcomes measure: Change of the Young Mania Rating Scale (YMRS) score, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haukeland University Hospital, status: RECRUITING, city: Bergen, zip: 5020, country: Norway, contacts name: Erik Johnsen, MD, PhD, role: CONTACT, phone: +47 55958400, email: erik.johnsen@helse-bergen.no, contacts name: Rune A Kroken, MD, PhD, role: CONTACT, phone: +47 55958400, email: rune.andreas.kroken@helse-bergen.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False