Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
Study NCT ID:
NCT03981159
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2019-03-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Exercise Training in Alzheimer's Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-pharmacological interventional study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2019-03-03', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinetti test', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'The 3-likert test assesses balance and gait abilities with an individual sitting in an armless chair, rising up, staying standing, turning 360° and then sitting back down. Gait is scored over 12 and balance is scored over 16, totalling 28 points.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Approximately 20 minutes', 'description': "The 14-item 5-likert (from 0 to 4) scale objectively determines a patient's balance ability during a series of predetermined tasks. Scores of each item are summed up: the total score ranges from 0 to 56. The lowest the score the lowest is the level of function, the highest the score the highest is the level of function."}, {'measure': '6-minute walking test', 'timeFrame': '6 minutes', 'description': 'This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.'}, {'measure': 'Timed up and go test', 'timeFrame': 'Approximately 14 seconds', 'description': 'The test measures abilities of a patient initially in a seated position The patient is then asked to stand up up, walk 3 meters, turn around, walk back to the chair and sit down.'}, {'measure': '"Walking While Talking" test', 'timeFrame': 'Approximately 1 minute', 'description': 'This test is a dual-task test, consisting in walking while reciting the alphabet or alternate letters of the alphabet.'}, {'measure': 'Red blood cell count', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'White blood cell count', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Hemoglobin', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Platelet count', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Hematocrit', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Triglycerides', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Cholesterol', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Total bilirubin', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'AST (aspartate aminotransferase)', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'ALT (alanine aminotransferase)', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Blood pressure', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Creatinine', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Urea', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Glucose', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Sodium', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Calcium', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}, {'measure': 'Potassium', 'timeFrame': 'Approximately 10-15 minutes', 'description': 'Assessed with routine blood/biochemical assays'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.", 'detailedDescription': "Alzheimer's disease is a neurodegenerative disease characterized by progressive and irreversible degeneration of nerve cells. The loss of these cells leads to the continuous decline in muscle function with alterations in biochemical and haematological parameters. The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with official diagnosis of Alzheimer's disease;\n* Subjects with MMSE higher than12.\n\nExclusion Criteria:\n\n• Subjects with MMSE below 12 (indicating severe dementia and impairment)."}, 'identificationModule': {'nctId': 'NCT03981159', 'acronym': 'ExCiTE-A', 'briefTitle': "Effect of Exercise Training in Alzheimer's Patients", 'organization': {'class': 'OTHER', 'fullName': 'University of Genova'}, 'officialTitle': "Effect of Exercise Training on Biochemical and Gait/Balance Parameters in Alzheimer's Patients", 'orgStudyIdInfo': {'id': 'ExCiTE-A-17-0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active group (under physical training)', 'description': 'Subjects belonging to this arm underwent physical training for three months, twice per week (60 minutes per session).', 'interventionNames': ['Other: Physical training']}, {'type': 'NO_INTERVENTION', 'label': 'Passive group (no physical training)', 'description': 'Subjects served as controls.'}], 'interventions': [{'name': 'Physical training', 'type': 'OTHER', 'description': 'Physical training for three months, twice per week (60 minutes per session).', 'armGroupLabels': ['Active group (under physical training)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genoa', 'country': 'Italy', 'facility': 'University of Genova', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}], 'overallOfficials': [{'name': 'Nicola L Bragazzi, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita degli Studi di Genova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Genova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maamer Slimani', 'investigatorAffiliation': 'University of Genova'}}}}