Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT01842412
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2013-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'muscle tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial function', 'timeFrame': 'One day', 'description': 'respirometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mitochondria, Muscle', 'Exercise'], 'conditions': ['Intermittent Claudication']}, 'referencesModule': {'references': [{'pmid': '27760222', 'type': 'RESULT', 'citation': 'van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJ. Mitochondrial Respiration after One Session of Calf Raise Exercise in Patients with Peripheral Vascular Disease and Healthy Older Adults. PLoS One. 2016 Oct 19;11(10):e0165038. doi: 10.1371/journal.pone.0165038. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient clinic, vascular surgery, Trondheim, Norway', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A history of any type of uni- or bilateral exertion leg pain.\n* A maximal claudication distance that is less than 300 meter\n* Diagnosed with intermittent claudication secondary to vascular insufficiency\n* An ankle-brachial index between 0.4 and 0.9.\n* Lives in Trondheim\n\nExclusion Criteria:\n\n* Diagnosed with critical limb ischemia\n* ankle-brachial index \\> 0.90 or \\< 0.4\n* Limited exercise tolerance\n* Warfarin or heparin usage\n* Diabetes mellitus\n* Underwent a vascular intervention in the last 3 months\n* Active cancer, renal- or liver disease.'}, 'identificationModule': {'nctId': 'NCT01842412', 'briefTitle': 'The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication', 'orgStudyIdInfo': {'id': '2013/395/REK midt'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'claudication', 'interventionNames': ['Behavioral: exercise']}, {'label': 'healthy', 'interventionNames': ['Behavioral: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'one bout of exercise training', 'armGroupLabels': ['claudication', 'healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'state': 'Postboks 8905', 'country': 'Norway', 'facility': 'Department for circulation and medical imaging, NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øyvind Ellingsen, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegisn University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}