Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 11:31 AM
Study NCT ID:
NCT02310256
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial on the Effects of Home-based Five Plus Exercise Training
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absolute walking distance (meters) as measured by 6 minute walking test', 'timeFrame': '8 weeks', 'description': 'treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test'}, {'measure': 'mitochondrial function measured by respirometry', 'timeFrame': '8 weeks', 'description': 'Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry'}], 'secondaryOutcomes': [{'measure': 'Arterial bloodflow measured by plethysmography', 'timeFrame': '8 weeks', 'description': 'measured by plethysmography'}, {'measure': 'Quality of life assessed by SF 36 and CLAU-S questionnaires', 'timeFrame': '8 weeks', 'description': 'assessed by SF 36 and CLAU-S questionnaires'}, {'measure': 'Peak oxygen uptake measured by cardio-pulmonal exercise testing', 'timeFrame': '8 weeks', 'description': 'measured by cardio-pulmonal exercise testing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mitochondria, muscle', 'Exercise', 'Blood Flow Velocity'], 'conditions': ['Intermittent Claudication']}, 'referencesModule': {'references': [{'pmid': '28285932', 'type': 'RESULT', 'citation': 'Van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson E. Calf raise exercise increases walking performance in patients with intermittent claudication. J Vasc Surg. 2017 May;65(5):1473-1482. doi: 10.1016/j.jvs.2016.12.106. Epub 2017 Mar 9.'}, {'pmid': '28592294', 'type': 'RESULT', 'citation': 'van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJR. Exercise in claudicants increase or decrease walking ability and the response relates to mitochondrial function. J Transl Med. 2017 Jun 7;15(1):130. doi: 10.1186/s12967-017-1232-6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with intermittent claudication secondary to vascular insufficiency\n* An ankle-brachial index between 0.4 and 0.9.\n\nExclusion Criteria:\n\n* Diagnosed with critical limb ischemia\n* Ankle-brachial index (ABI) \\> 0.90 or \\< 0.4\n* Limited exercise tolerance\n* Warfarin or heparin usage\n* Underwent a vascular intervention in the last 6 months\n* Active cancer, renal- or liver disease'}, 'identificationModule': {'nctId': 'NCT02310256', 'briefTitle': 'A Clinical Trial on the Effects of Home-based Five Plus Exercise Training', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training', 'orgStudyIdInfo': {'id': '2011/2533/REK midt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Five Plus', 'description': 'Exercise training', 'interventionNames': ['Other: Five plus exercise training']}], 'interventions': [{'name': 'Five plus exercise training', 'type': 'OTHER', 'description': 'calf raise exercise', 'armGroupLabels': ['Five Plus']}]}, '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': 'Øivind Rognmo, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}