Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT04496934
Status:
SUSPENDED
Last Update Posted:
2025-04-02
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': '2019-01-11', 'size': 577641, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-29T06:54', 'hasProtocol': True}, {'date': '2019-01-11', 'size': 575869, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-29T09:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'COVID-19 pandemic', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height and weight', 'timeFrame': '12 weeks', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Endurance', 'timeFrame': '12 weeks', 'description': 'Ventilatory threshold/VO2max (endurance test on treadmill)'}, {'measure': 'Strength', 'timeFrame': '12 weeks', 'description': 'Push-ups (maximal test where the participants perform a maximum number of correct push-ups)'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': "Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)"}], 'secondaryOutcomes': [{'measure': 'Alcohol use', 'timeFrame': '12 weeks', 'description': 'AUDIT-E'}, {'measure': 'Drug use', 'timeFrame': '12 weeks', 'description': 'DUDIT-E'}, {'measure': 'Executive functions', 'timeFrame': '12 weeks', 'description': 'Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)'}, {'measure': 'Satisfaction with life', 'timeFrame': '12 weeks', 'description': 'Satisfaction With Life Scale (SWLS)\n\nValues/scores:\n\n* 7 - Strongly agree\n* 6 - Agree\n* 5 - Slightly agree\n* 4 - Neither agree nor disagree\n* 3 - Slightly disagree\n* 2 - Disagree\n* 1 - Strongly disagree\n\nResults (sum of scores/values):\n\n31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied The higher the score the better the outcome.'}, {'measure': 'Sleep quality', 'timeFrame': '12 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Attention', 'timeFrame': '12 weeks', 'description': 'Connors Continuous Performance Test (CPT 3)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder', 'Substance Use Disorders', 'Opioid Dependence']}, 'descriptionModule': {'briefSummary': "In terms of research, it is documented that exercise has a positive effect on mental disorders. Studies have shown positive correlations between physical and mental health, also among substance users. Such a study has never been performed on patients in opioid substitution therapy (OST). Documentation on the physical health of patients and the effect of exercise is very limited. Treatment of substance users is a research area with insufficient knowledge about certain treatment effects. It is important that a treatment can both support and promote the user's own resources and efforts to change their habits of substance use.\n\nThe objective of this project is to examine the effect of exercise for OST patients, measured in relation to cognitive function and physical form. The target group consists of OST patients from 18 years of age and up, of both sexes, and on stable medication. At least 60 participants should complete the project, which is designed as a controlled randomized study (RCT). Participants in the intervention group start to exercise immediately after baseline testing. Participants in the control group are on a waiting list and will start to exercise after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months. Testing consists of two parts: A battery of cognitive and psychosocial assessments and an assessment of physical variables.\n\nThe research questions of this project are important in a public health perspective. Generated knowledge can be quickly applied to local treatment institutions in Norway."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must sign a informed consent form\n* Must be participating in an opioid substitution program\n* Must be on a steady fixed dose of medication\n* Must be at least 18 years of age\n\nExclusion Criteria:\n\n* Pregnancy\n* Being in opioid substitution program for less than three months'}, 'identificationModule': {'nctId': 'NCT04496934', 'briefTitle': 'Physical Activity as Adjunct Treatment for Opioid Substitution Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Physical Activity as Adjunct Treatment for Opioid Substitution Therapy', 'orgStudyIdInfo': {'id': '2013/00731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Exercise intervention', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Asgeir Mamen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kristiania University College'}, {'name': 'Lars Thore Fadnes, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Bergen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'Kristiania University College', 'class': 'OTHER'}, {'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Western Norway University of Applied Sciences', 'class': 'OTHER'}, {'name': 'Solli Distriktspsykiatriske Senter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}