Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-09 @ 8:19 AM
Study NCT ID:
NCT03358433
Status:
UNKNOWN
Last Update Posted:
2017-11-30
First Post:
2017-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Exercise in the Treatment of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-25', 'studyFirstSubmitDate': '2017-11-25', 'studyFirstSubmitQcDate': '2017-11-25', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in depressive symptoms', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Depression', 'Primary Care', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '34264835', 'type': 'DERIVED', 'citation': 'Hidalgo JL, Sotos JR; DEP-EXERCISE Group. Effectiveness of Physical Exercise in Older Adults With Mild to Moderate Depression. Ann Fam Med. 2021 Jul-Aug;19(4):302-309. doi: 10.1370/afm.2670.'}, {'pmid': '30642326', 'type': 'DERIVED', 'citation': 'Lopez-Torres Hidalgo J; DEP-EXERCISE Group. Effectiveness of physical exercise in the treatment of depression in older adults as an alternative to antidepressant drugs in primary care. BMC Psychiatry. 2019 Jan 14;19(1):21. doi: 10.1186/s12888-018-1982-6.'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.', 'detailedDescription': 'This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with depression\n\nExclusion Criteria:\n\n* Contraindication to exercise'}, 'identificationModule': {'nctId': 'NCT03358433', 'acronym': 'DEP-EXERCISE', 'briefTitle': 'Effectiveness of Exercise in the Treatment of Depression', 'organization': {'class': 'OTHER', 'fullName': 'Gerencia de Atención Primaria, Albacete'}, 'officialTitle': 'Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care', 'orgStudyIdInfo': {'id': 'PI15/01486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'interventionNames': ['Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antidepressants', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'otherNames': ['Antidepressants'], 'armGroupLabels': ['Antidepressants', 'Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02006', 'city': 'Albacete', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesús López-Torres Hidalgo, MD', 'role': 'CONTACT', 'email': 'jesusl@sescam.org', 'phone': '+34653137665'}], 'facility': 'Jesús López-Torres Hidalgo', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'city': 'Albacete', 'status': 'RECRUITING', 'country': 'Spain', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}], 'centralContacts': [{'name': 'Jesús López-Torres Hidalgo, MD', 'role': 'CONTACT', 'email': 'jesusl@sescam.org', 'phone': '+34653137665'}], 'overallOfficials': [{'name': 'Jesús López-Torres Hidalgo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Salud Zona VIII de Albacete (Spain)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerencia de Atención Primaria, Albacete', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jesús López-Torres Hidalgo', 'investigatorAffiliation': 'Gerencia de Atención Primaria, Albacete'}}}}