Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 6:26 AM
Study NCT ID:
NCT00333905
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2006-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ischemic Training on Exercise Endurance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2006-06-02', 'studyFirstSubmitQcDate': '2006-06-02', 'lastUpdatePostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.'}], 'secondaryOutcomes': [{'measure': 'Peak cycle ergometer VO2max test before and after training'}]}, 'conditionsModule': {'keywords': ['Exercise', 'Exercise Therapy'], 'conditions': ['Heart Failure', 'Congestive Heart Failure', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '16320146', 'type': 'BACKGROUND', 'citation': 'Loeppky JA, Gurney B, Kobayashi Y, Icenogle MV. Effects of ischemic training on leg exercise endurance. J Rehabil Res Dev. 2005 Jul-Aug;42(4):511-22. doi: 10.1682/jrrd.2004.06.0069.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if reducing blood flow to an exercising muscle during exercise training will enhance the training effect on that muscle in people who have limited exercise because of congestive heart failure', 'detailedDescription': 'The objective of this study is to determine whether reduction of blood flow during stair-stepping and cycling ergometer leg exercise will contribute to an improvement in whole body exercise capacity or submaximal exercise endurance in patients with mild congestive heart failure. Two groups of 25 patients with mild to moderate CHF, aged 30-70, will be trained for 12 weeks. The experimental group will train with pressure cuffs inflated on one thigh and lower leg during exercise. The cuff will be applied on alternate legs during training, such that each leg has the same duration of ischemic training. The control group will train for a similar duration and intensity without pressure cuffs on the legs. Pre and post training measures will include VO2peak, exercise duration at 30% VO2peak, 6 minute walk test, Minnesota Living with Heart Failure questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild Congestive Heart Failure\n* Must be able to exercise\n\nExclusion Criteria:\n\n* Venous or arterial thrombus\n* Lower extremity arthritis\n* Blood clotting abnormalities\n* Claudication\n* Peripheral vascular disease\n* Evidence of deep vein thrombosis on ultrasound'}, 'identificationModule': {'nctId': 'NCT00333905', 'briefTitle': 'The Effect of Ischemic Training on Exercise Endurance', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'The Effect of Ischemic Training on Exercise Endurance', 'orgStudyIdInfo': {'id': 'F4096R'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ischemic exercise training', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico VA Health Care System', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Milton V Icenogle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}}}}