Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04239612
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2019-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fitforlife- Exercise in Care of Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-01', 'size': 134525, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-20T04:47', 'hasProtocol': True}, {'date': '2019-06-01', 'size': 72608, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-20T04:47', 'hasProtocol': False}, {'date': '2019-06-01', 'size': 54065, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-11-20T04:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients attending open care units for psychosis will be invited to participate'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in overall function from baseline to 6 months', 'timeFrame': '6 months', 'description': 'Overall function according to sum of items in WHODAS (World Health Organization Disability Assessment Schedule). 36 items, Score 0-5 on each item, higher values- lower function.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Mass Index(BMI) from baseline to 6 months', 'timeFrame': '6 months', 'description': 'Weight and height will be combined to report BMI in kg/m2. Values \\>25 overweight, \\>30 obesity.'}, {'measure': 'Change in Inflammatory markers from baseline to 6 months', 'timeFrame': '6 months', 'description': 'Interleukin-6 (Il6), Tumour necrosis Factor (TNFalfa), C-reaktive protein(CRP) all measured in pg/ml. No normal values exists. Will be compared to healthy controls.'}, {'measure': 'Changes from baseline to 6 months in cognitive function', 'timeFrame': '6 months', 'description': 'Measured with Cogstate brief battery (Computerized congitive assessment) - score of the summarised tests. Generated through a computerized program, comparsion to age-matched controls.'}, {'measure': 'Change in Glycated Hemoglobin (HBA1c )', 'timeFrame': '6 months', 'description': 'HBA1c measured in mmol/mol. Compared to normal values.'}, {'measure': 'Change in fitness', 'timeFrame': '6 months', 'description': 'Fitness measured as VO2 (Volyme Oxygene) max in a bicycle submax test (Ekblom-Bak). Will be compared to tables for normal values according to age.'}, {'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': '6 months', 'description': 'Blood pressure measured as mm hg. Will be compared to normal age related values.'}, {'measure': 'Changes in blood lipids', 'timeFrame': '6 months', 'description': 'Blood lipids includes cholesterol (LDL-C) measured in mg/dl, Low density lipoprotein (LDL) High density lipoprotein-cholesterol (HDL-C) and triglycerides- all measured in mg/dl. Will be compared to standard normal values according to age.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychotic disorders', 'Exercise', 'Cognition', 'Metabolic markers'], 'conditions': ['Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '29957552', 'type': 'RESULT', 'citation': 'Lambden B, Berge J, Forsell Y. Structured physical exercise and recovery from first episode psychosis in young adults, the FitForLife study. Psychiatry Res. 2018 Sep;267:346-353. doi: 10.1016/j.psychres.2018.06.001. Epub 2018 Jun 19.'}, {'pmid': '29729687', 'type': 'RESULT', 'citation': 'Hallgren M, Skott M, Ekblom O, Firth J, Schembri A, Forsell Y. Exercise effects on cognitive functioning in young adults with first-episode psychosis: FitForLife. Psychol Med. 2019 Feb;49(3):431-439. doi: 10.1017/S0033291718001022. Epub 2018 May 6.'}]}, 'descriptionModule': {'briefSummary': 'Persons affected by psychosis have a shorter life expectancy mainly due to metabolic disorders. This is partly due to the drugs but also to a sedentary life style.\n\nIt is often a life long disorder with decreased overall function and thus need of life long care, both informal and formal. It is also a highly stigmatising disorder.\n\nWe are aiming at adding peer mentor led regular physical exercise to the open care of psychosis. it is well-known that physical exercise increase overall function, decrease metabolic risk factors and increase cognition. By using educated peer mentors who will lead the exercise sessions this will have an anti-stigmatising effect and improve self-confidence.', 'detailedDescription': 'Purpose and aims The overall purpose is to integrate peer-mentor supervised regular physical exercise in the open care of persons affected by psychosis. For specific research questions see separate information.\n\nRecruitment of units and mentors Psychiatric open care units who are responsible for care of persons affected by psychosis will be contacted. First in Stockholm then in the rest of Sweden.\n\nThose who are interested will assign 1-2 local contact persons from the staff and recruit 4 potential peer mentors among their patients.\n\nPeer mentor education The peer mentors will be educated to be able to lead physical exercise sessions for other patients. Two units (8 mentors) will be educated together and the local contact persons will also attend. The education consists of three half days and is lead by a person educated in health pedagogics and physical exercise. It consists of theory and practice about physical exercise sessions with focus on circular training. A lof of emphasis will be put put on leadership and encouragement. The curriculum of the education is based on the pilot study.\n\nRecruitment of participants The local contact persons together with the health care staff at the local units will recruit participants to the exercise sessions.\n\nThey will also perform the initial and 6 month follow up examinations. In order to do this they will receive education and support from the research team. A carefully written instruction is administered. This procedure is described in detail in the study protocol.\n\nExercise sessions Each included unit will have exercise sessions at the unit. Numbers/week depends on the number of recruited participants. Schedule will be done by the local peer mentors and the local contact person together. The sessions will be entirely led by the peer mentors.\n\nBefore the sessions the local contact persons will register the participants when they arrive. After the session the peer mentor will report to the local contact person how the session went. These data will be transferred to the research team.\n\nSupport to the peer mentors For six months the educated peer mentors will have support from a health pedagogical team. The support is both face-to-face and electronic.\n\nTime period The study will record data for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• All persons attending open care psychiatric units for psychosis\n\nExclusion Criteria:\n\n• Judged by the responsible psychiatrist that physical exercise in groups is not suitable'}, 'identificationModule': {'nctId': 'NCT04239612', 'briefTitle': 'Fitforlife- Exercise in Care of Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis', 'orgStudyIdInfo': {'id': '102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Physical exercise', 'description': 'Specified circular training, 60 minutes, 1-3 times/week', 'interventionNames': ['Behavioral: Physical exercise']}], 'interventions': [{'name': 'Physical exercise', 'type': 'BEHAVIORAL', 'description': 'Regular physical exercise in groups. Circular training: both strength and fitness', 'armGroupLabels': ['Physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Stockholm county council', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Yvonne Forsell, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Region Skåne', 'class': 'UNKNOWN'}, {'name': 'Region Halland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yvonne Forsell', 'investigatorAffiliation': 'Karolinska Institutet'}}}}