Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-28 @ 9:01 PM
Study NCT ID:
NCT00904761
Status:
COMPLETED
Last Update Posted:
2012-12-28
First Post:
2009-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-27', 'studyFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart rate variability', 'timeFrame': '8 weeks'}, {'measure': 'exercise capacity', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'autonomic neuropathy', 'exercise training', 'exercise capacity', 'heart rate variability'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate effects of physical training on exercise capacity and changes of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient with diabetes with autonomic neuropathy (DAN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged under 65 years old\n* receiving regular treatment\n* HbA1c \\< 8.0\n* decreased HR response in deep breathing maneuver\n\nExclusion Criteria:\n\n* heart disease\n* neuro-musculo-skeletal diseases\n* taking any medication that may affect HRV (such as α or β-blockers)'}, 'identificationModule': {'nctId': 'NCT00904761', 'briefTitle': 'Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy', 'orgStudyIdInfo': {'id': '25670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise', 'description': 'arm: intervention', 'interventionNames': ['Other: exercise training']}], 'interventions': [{'name': 'exercise training', 'type': 'OTHER', 'description': 'The exercise group took supervised aerobic training twice per week at hospital and thrice per week at home for eight weeks at the intensity of 60-70% VO2peak', 'armGroupLabels': ['exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ying-Tai Wu, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}