Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02147912
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2014-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Depression In Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'variation of HDRS total score', 'timeFrame': '6 weeks after intervention phase', 'description': 'we compare the variation of HDRS total score, as primary outcome measure, in two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status; age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic exercise intervention.'}], 'secondaryOutcomes': [{'measure': 'daily functioning assessment', 'timeFrame': '6 weeks after intervention phase', 'description': 'Evaluation of potential benefits on: anxiety symptoms, cognitive features, daily physical function (related to physical performances and/or to psychopathological dimensions) and quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'COPD', 'Aerobic Exercise', 'Anxiety', 'Quality of life', 'neurocognitive functioning'], 'conditions': ['Depression in Patients With Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': "Background:\n\nSeveral clinical studies show high rates of anxiety and depressive disorders in Chronic Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms of COPD and depressive disorders. The aim of this study is to evaluate the effects of aerobic exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD depressed patients without psychopharmacological treatment, through the correlation of some psychopathological variables and physical/pneumological parameters.\n\nMethods:\n\nThe investigators have designed an observational longitudinal trial. The trial will be prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life and neurocognitive function.\n\nOutcome measures:\n\nThe investigators compare the variation of HDRS total score, as primary outcome measure, in two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status; age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic exercise intervention.\n\nStatistical analysis:\n\nAll tests are two-tailed and a p value 0.05 was considered significant. The difference between the two groups will be evaluated with Student's T test for normally distributed data, and with Mann-Whitney's U test, for those with not normal distribution. The normality of distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among the variables under evaluation will be assessed by Spearman r correlation. Variables will be compared using the Chi-squared test or Fisher exact test for categorical variables.\n\nDiscussion:\n\nThere is a strong correlation between physical activity and mental health. Several data have suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose an effective intervention to reduce the risk of severe depression in this special population, evaluating the variation of HDRS total score after the aerobic exercise intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of COPD and depression, eligibility to perform pulmonary rehabilitation according to ATS and ERS guidelines.\n\nExclusion Criteria:\n\nindication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).'}, 'identificationModule': {'nctId': 'NCT02147912', 'acronym': 'EDIC', 'briefTitle': 'Evaluation of Depression In Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Catania'}, 'officialTitle': 'Evaluation of Depression In Chronic Obstructive Pulmonary Disease: a Longitudinal Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'UHCatania'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic exercise', 'description': 'A six week aerobic exercise intervention in COPD depressed population.', 'interventionNames': ['Other: Aerobic Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control sample', 'description': 'Only participants randomized in the arm named "Aerobic exercise" will receive a six weeks aerobic exercise intervention.'}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'OTHER', 'description': 'Aerobic exercise intervention consists of lower (treadmill and cyclette) and upper arts (arm ergometer Davenbike®) training, as well as calisthenic exercises with increasing intensity from a minimum of 80% to a maximum workload for lower arts in a minimum time.', 'armGroupLabels': ['Aerobic exercise']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Giuseppe Minutolo, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppeminutolo@hotmail.com', 'phone': '+39 0953782791'}, {'name': 'Francesca Magnano S. Lio, MD', 'role': 'CONTACT', 'email': 'francesca.magnanosanlio@gmail.com', 'phone': '+39 0953782470'}], 'overallOfficials': [{'name': 'Eugenio Aguglia, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy'}, {'name': 'Giuseppe Minutolo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy'}, {'name': 'Giuseppe Catalfo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy'}, {'name': 'Francesca Magnano S. Lio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy'}, {'name': 'Nunzio Crimi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Rehabilitation Clinic - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele. Via S. Sofia, 78 - 95124 Catania, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Psychiatry', 'investigatorFullName': 'Prof. Eugenio Aguglia', 'investigatorAffiliation': 'University Hospital, Catania'}}}}