Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 9:12 PM
Study NCT ID:
NCT00733161
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2008-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2008-08-11', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Left ventricular systolic and diastolic function', 'timeFrame': '2 weeks'}, {'measure': 'Six-minute walk distance', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'keywords': ['passive leg exercise', 'congestive heart failure', 'endothelium-derived factors', 'elderly'], 'conditions': ['Congestive Heart Failure', 'Endothelium-derived Factors', 'Elderly']}, 'referencesModule': {'references': [{'pmid': '22664754', 'type': 'DERIVED', 'citation': 'Ozasa N, Morimoto T, Bao B, Shioi T, Kimura T. Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. Circ J. 2012;76(8):1889-94. doi: 10.1253/circj.cj-11-1113. Epub 2012 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.', 'detailedDescription': 'Endothelial function is known to be impaired in patients with chronic heart failure (CHF) and impaired endothelial function has been reported to be associated with an increased mortality risk in those subjects. Although systemic exercise training has been demonstrated to improve endothelial dysfunction in patients with CHF, elderly patients with severely impaired exercise capacity could not engaged in usual exercise training using ordinal ergometer. Those patients are able to join stretching or very light resistance training. On the other hand, passive pedaling using strength ergometer has been reported to be useful in patients with severely impaired exercise capacity, but the safety and the efficacy of passive pedaling on endothelial function in old patients with CHF has not been previously reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic heart failure\n* Elderly patients aged ≧65 years\n* Patients with severely reduced exercise capacity and cannot continue exercise with usual cycling ergometer for 5 minutes\n\nExclusion Criteria:\n\n* Unstable hemodynamic status (uncontrolled arrhythmia, uncontrolled congestion, uncontrolled hypertension)\n* Active infectious disease\n* Malignancy\n* Chronic obstructive pulmonary disease\n* Dialysis\n* Severe aortic valve disease\n* With any hip, knee, ankle joint pain\n* Hemiplegia\n* Current smoker'}, 'identificationModule': {'nctId': 'NCT00733161', 'briefTitle': 'Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University'}, 'officialTitle': 'Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': '20795203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Passive leg cycle exercise with stretching and resistance training', 'interventionNames': ['Other: Passive leg cycle exercise with stretching and resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Stretching and resistance training', 'interventionNames': ['Other: Stretching and resistance training']}], 'interventions': [{'name': 'Passive leg cycle exercise with stretching and resistance training', 'type': 'OTHER', 'description': 'Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training', 'armGroupLabels': ['1']}, {'name': 'Stretching and resistance training', 'type': 'OTHER', 'description': 'Stretching and resistance training everyday but no Passive leg cycle exercise', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Takeshi Kimura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Takeshi Morimoto', 'investigatorAffiliation': 'Kyoto University'}}}}