Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06313918
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Therapy in Mental Disorders-study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '26 weeks', 'description': 'Proportion (number and percent) of completers at 26 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Symptoms of psychosis'}, {'measure': 'Change of the Calgary Depression Scale in Schizophrenia score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Symptoms of depression'}, {'measure': 'Change of the Clinical Global Impression (CGI) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Overall clinical state'}, {'measure': 'Change of the Global Assessment of Funtioning (GAF) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Functioning'}, {'measure': 'Change of quality of life (QOL10) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Quality of life'}, {'measure': 'Change of the International Physical Activity Questionaire (IPAQ) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Physical activity'}, {'measure': 'Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Cognition'}, {'measure': 'Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Motivation'}, {'measure': 'Change of the Difficulties in Emotion Regulation (DERS) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Emotion regulation'}, {'measure': 'Change in heart rate (beats per minute)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Heart rate variability'}, {'measure': 'Change of maximal oxygene extraction (VO2max)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Aerobic capacity'}, {'measure': 'Change of level of inflammatory markers in blood', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Inflammation'}, {'measure': 'Change of body weight (kilograms)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Body weight change'}, {'measure': 'Change of hip- and waist circumference (centimetres)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Change of hip- and waist circumference'}, {'measure': 'Change of serum glucose (mmol/L)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Change of serum glucose'}, {'measure': 'Change of serum cholesterols (mmol/L)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Change of serum cholesterols'}, {'measure': 'Change of serum triglyceride (mmol/L)', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Change of serum triglyceride (mmol/L)'}, {'measure': 'Change of gene expression', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'RNA'}, {'measure': 'Change of methylation of DNA', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Epigenetic changes'}, {'measure': 'Change of the Young Mania Rating Scale (YMRS) score', 'timeFrame': '4, 12, 26 and 52 weeks from baseline', 'description': 'Symptoms of mania'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise therapy', 'Effectiveness'], 'conditions': ['Schizophrenia and Related Disorders', 'Bipolar Disorder']}, '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.', 'detailedDescription': 'Background: Patients with severe mental disorders (SMD), including schizophrenia spectrum and bipolar disorders, frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges, and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population.\n\nCardiovascular disease (CVD) is a major contributor in this regard. Exercise in general improves cognitive functioning, negative symptoms, quality of life, and reduces the risk of CVD. High intensity training (HIT) has been shown to be feasible for persons with SMD, but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT. A less strenuous HIT could increase adherence to the intervention, which might compensate for a slightly lower efficacy compared to standard HIT. Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session, as well as explore exercise effects on basic processes in the body. Methods: Patients with schizophrenia spectrum and bipolar disorders are eligible for participation, and those included will be randomized to 26 weeks of either 1) Standard 4 x 4 min HIT at treadmill, or 2) Short 1 x 4 min HIT at treadmill. To reduce dropout, the intervention will usually be delivered in group format, and conducted under the supervision of a physical therapist in collaboration with a postdoctor. The research group has a stable staff with research nurses, biostatisticians and researchers that will secure the dayto- day conductance of the project, including psychometric assessments, drawing of and biobanking of blood, as well as data collection and storing. Measures: Mental and cognitive symptoms, quality of life, motivation, Peak oxygen uptake (V'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICD-10 schizophrenia-spectrum disorder (F2)\n* ICD-10 bipolar disorder (F3)\n* Capacity to provide informed consent.\n\nExclusion Criteria:\n\n* Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications\n* Life threatening or terminal medical conditions\n* Not able to carry out intervention or test procedures\n* Current pregnancy\n* Mothers less than 6 months post-partum.'}, 'identificationModule': {'nctId': 'NCT06313918', 'briefTitle': 'Exercise Therapy in Mental Disorders-study', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Exercise Therapy in Mental Disorders-study', 'orgStudyIdInfo': {'id': 'REK nr. 428096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard HIT', 'description': 'Standard 4 x 4 min HIT at treadmill. First 7 min warm-up, then 4 sessions with 4 min walking/running at 80-95% of maximal heart rate, with 3 min of active rest in between. Ending with 5 min of cooling down. Two sessions per week for 26 weeks.', 'interventionNames': ['Other: High intensity training (HIT)']}, {'type': 'EXPERIMENTAL', 'label': 'Short HIT', 'description': 'Short 1 x 4 min HIT at treadmill. Starting with 7 min warm-up walking/running, then 1 session with 4 min walking/running at 80-95% of maximal heart rate, ending with 5 min of cooling down. Two sessions per week for 26 weeks.', 'interventionNames': ['Other: High intensity training (HIT)']}], 'interventions': [{'name': 'High intensity training (HIT)', 'type': 'OTHER', 'description': 'Please see information already included in the arm descriptions.', 'armGroupLabels': ['Short HIT', 'Standard HIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Erik Johnsen, MD, PhD', 'role': 'CONTACT', 'email': 'erik.johnsen@helse-bergen.no', 'phone': '+47 55958400'}, {'name': 'Rune A Kroken, MD, PhD', 'role': 'CONTACT', 'email': 'rune.andreas.kroken@helse-bergen.no', 'phone': '+47 55958400'}], 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Erik Johnsen, PhD', 'role': 'CONTACT', 'email': 'erik.johnsen@helse-bergen.no', 'phone': '004792456225'}, {'name': 'Rune A Kroken, PhD', 'role': 'CONTACT', 'email': 'rune.andreas.kroken@helse-bergen.no', 'phone': '004792095205'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}