Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03965520
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2019-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Test and Sequential Training Strategies in PAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-26', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-26', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical fitness (peak oxygen consumption)', 'timeFrame': 'after 36 session exercise training, up to 12 weeks', 'description': 'oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test'}, {'measure': 'physical fitness (exercise duration)', 'timeFrame': 'after 36 session exercise training, up to 12 weeks', 'description': 'exercise duration in seconds measured during cardiopulmonary exercise test'}, {'measure': 'physical fitness (walking distance)', 'timeFrame': 'after 36 session exercise training, up to 12 weeks', 'description': 'walking distance in meters measured during six minutes walking test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peripheral arterial disease', 'exercise training', 'local aerobic training'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.\n\nIn past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.\n\nTo enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.\n\nTherefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease.', 'detailedDescription': 'Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.\n\nIn past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.\n\nTo enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.\n\nTherefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ankle-brachial index \\<0.9\n\nExclusion Criteria:\n\n* 1.\\<20 years old 2. There are other diseases or behavioral restrictions that prevent exercise training 3. Other exercise contraindications:\n\n 1. unstable angina\n 2. resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg\n 3. orthostatic blood pressure drop greater than 20 mmHg with symptoms\n 4. Symptomatic severe aortic stenosis\n 5. Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands\n 6. Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise\n 7. Uncontrolled symptomatic heart failure\n 8. High-degree atrioventricular blocks\n 9. Acute myocarditis or pericarditis\n 10. Acute pulmonary embolus or pulmonary infarction\n 11. a recent significant change in the resting electrocardiogram suggesting significant ischemia,\n 12. recent myocardial infarction (within 2 d), or other acute cardiac events'}, 'identificationModule': {'nctId': 'NCT03965520', 'briefTitle': 'Exercise Test and Sequential Training Strategies in PAD', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': '103-4837B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'usual training', 'description': 'exercise intensity arranged by cardiopulmonary exercise test results', 'interventionNames': ['Behavioral: exercise rehabilitation by near-infrared spectrometer']}, {'type': 'EXPERIMENTAL', 'label': 'Novel exercise training', 'description': 'exercise intensity monitor by near-infrared spectrometer', 'interventionNames': ['Behavioral: exercise rehabilitation by near-infrared spectrometer']}], 'interventions': [{'name': 'exercise rehabilitation by near-infrared spectrometer', 'type': 'BEHAVIORAL', 'description': 'We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer', 'armGroupLabels': ['Novel exercise training', 'usual training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '204', 'city': 'Keelung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tieh Cheng Fu, MD, PhD', 'role': 'CONTACT', 'email': 'mr5598@adm.cgmh.org.tw', 'phone': '886-2-24313131', 'phoneExt': '2626'}, {'name': 'Tieh-Cheng Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}