Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-07 @ 11:05 AM
Study NCT ID:
NCT00594360
Status:
UNKNOWN
Last Update Posted:
2008-01-15
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effect of Exercise on Prescription - a Psychological Perspective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-01-03', 'studyFirstSubmitDate': '2008-01-03', 'studyFirstSubmitQcDate': '2008-01-03', 'lastUpdatePostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported Self-efficacy level at 4, 10 and 16 months. Patient-reported Decisional balance level at 4, 10 and 16 months. Patient-reported Readiness to change level at 4, 10 and 16 months.', 'timeFrame': '16 months'}], 'secondaryOutcomes': [{'measure': 'Patient-reported physical activity level at 4, 10 and 16 months. . Patient-reported health related quality of life at 4, 10 and 16 months. Patient-reported compliance with national guidelines for physical activity at 4, 10 and 16 months.', 'timeFrame': '16 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise Prescription', 'Self-efficacy', 'Decisional Balance', 'Readiness to Change', 'Physical Activity'], 'conditions': ['Physical Inactivity', 'Motivation', 'Behavior Change']}, 'referencesModule': {'references': [{'pmid': '18582371', 'type': 'DERIVED', 'citation': "Bredahl TV, Puggaard L, Roessler KK. Exercise on Prescription. Effect of attendance on participants' psychological factors in a Danish version of Exercise on Prescription: a study protocol. BMC Health Serv Res. 2008 Jun 26;8:139. doi: 10.1186/1472-6963-8-139."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the effect of a primary healthcare intervention called 'Exercise on Prescription' aimed at increasing level of physical activity and psychological parameters in a population of sedentary patients with increased risk of developing lifestyle diseases. The effect is evaluated using patient-reported variables.", 'detailedDescription': "Exercise prescriptions are used for initiating a physical active lifestyle in sedentary populations.\n\nA Danish project called 'Exercise on Prescription' (EoP) is implemented in primary healthcare. Patients eligible for EoP are non-institutionalised adults with medically controlled lifestyle diseases or risk factors of lifestyle diseases, who are motivated to change lifestyle, able to improve health status through a physical active lifestyle, and willing to pay a fee of €100 for the intervention.\n\nThe purpose of this study is to assess the effect on: 1) Self-efficacy, 2) Readiness to change, 3) Decisional balance, 4) physical activity level, and 5) health related quality of life.\n\nThe EoP-group is compared to an intervention group receiving only motivational counselling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients referred to the Exercise on Prescription scheme by their general practitioner\n* Volunteer to participate in the trial\n\nExclusion Criteria:\n\n* BMI over 35'}, 'identificationModule': {'nctId': 'NCT00594360', 'acronym': 'EoP', 'briefTitle': 'Evaluation of Effect of Exercise on Prescription - a Psychological Perspective', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Exercise on Prescription: Effects and Comparison of Psychological Parameters Physical Activity, Physical Fitness, and Health Physical Between Participants in a Danish Version of Exercise on Prescription.', 'orgStudyIdInfo': {'id': '36/154-150775'}, 'secondaryIdInfos': [{'id': '2005-41-5248'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Behavioral: Exercise on Prescription']}], 'interventions': [{'name': 'Exercise on Prescription', 'type': 'BEHAVIORAL', 'otherNames': ['Open Label, Active Control, Efficacy Study, Best practice'], 'description': 'Exercise two times a week for two months at a physiotherapist. Afterwards exercise one time a week at a physiotherapist and self-contained training one time a week for 2 months.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Centre of Applied and Clinical Exercise Science, Institute og Sport Sciences and Clinical Biomechanics, University of Southern Denamrk', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Lis Puggaard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre of Applied and Clinical Exercise Science, Institute of Sport Sciences and Clinical Biomechanics, University of Southern Denmark, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The County of Funen, Denmark', 'class': 'OTHER_GOV'}, {'name': 'The County of Frederiksberg', 'class': 'UNKNOWN'}, {'name': 'National Board of Health, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Gitte Halling', 'oldOrganization': 'Faculty of Health Sciences, University of Southern Denmark, Denmark'}}}}