Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04141202
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2019-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical health', 'timeFrame': '18 months', 'description': 'Change in oxygen uptake'}, {'measure': 'Physical health', 'timeFrame': '18 months', 'description': 'Change in maximum leg strength'}, {'measure': 'Mental health', 'timeFrame': '18 months', 'description': 'assessed by a in-house developed questionnaire, which is composed of 4 parts: Severity of Dependence 5-items (each of the five items is scored on a 4-point scale (0-3). Total score is the sum of the 5-item ratings. The higher the score the higher the level of dependence); Circumstances, Motivation, Readiness, and Suitability instrument (Five items measured on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (totally agree). High scores indicate increased intrinsic motivation); Quality-of-Life rating five items recorded on a five-point Likert scale: 1 (very poor) - 5 (very good). The raw scores are transformed to a decimal scale, ranging from 0.1 worst score to 0.9 best score); Hopkins Symptom Checklist (HSCL-10): Ten items recorded on a four-point Likert scale: (1) not at all - (4) extremely.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise therapy', 'Exercise physiology'], 'conditions': ['Substance-Related Disorders', 'Drug Abuse', 'Drug Dependence']}, 'descriptionModule': {'briefSummary': "In 2017, structured physical exercise with high intensity was implemented as a part of the treatment program at St. Olav Hospital Clinic of Substance Use and Addiction Medicine.\n\nThe objective of this study is to examine whether implementing structured physical exercise in the treatment program has implications for patients' physical and mental health and quality of life after completing a 3 month residential treatment program.\n\nThe results of this study will benefit substance use disorder patients in the future, and may have an impact on further implementation of physical exercise in addiction treatment clinics both nationally and internationally."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed with substance use disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being an inpatient at the clinic\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04141202', 'briefTitle': 'Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder: Implications for Abstinence, Quality of Life, Physical- and Mental Health', 'orgStudyIdInfo': {'id': '2019/501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exercise group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7010', 'city': 'Trondheim', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Grete Flemmen, phd', 'role': 'CONTACT', 'email': 'grete.flemmen@stolav.no', 'phone': '+47 908 77 876'}], 'facility': 'St Olavs Hospital HF Klinikk for rus og avhengighetsmedisin', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Grete Flemmen, phd', 'role': 'CONTACT', 'email': 'grete.flemmen@stolav.no', 'phone': '+47 908 77 876'}, {'name': 'Henrik Loe, phd', 'role': 'CONTACT', 'email': 'henrik.loe@stolav.no'}], 'overallOfficials': [{'name': 'Kristin Smedsrud', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Olavs Hospital Klinikk for rus- og avhengighetsmedisin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}