Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-11 @ 7:35 AM
Study NCT ID:
NCT01980602
Status:
UNKNOWN
Last Update Posted:
2013-11-11
First Post:
2013-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise on Patients With Claudication Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'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': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2013-09-24', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care', 'timeFrame': '6 weeks', 'description': 'Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness'}], 'secondaryOutcomes': [{'measure': 'Measure the changes in muscle fibre type with exercise training or standard care', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, and 12 months', 'description': 'Histological analysis to measure the percentage of different types of muscle fibres, and how these are affected by 6 weeks of exercise compared to standard treatment.'}, {'measure': 'Measurement of endothelial function after a period or exercise therapy or standard care', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, and 12 months', 'description': 'To identify if 6 weeks of exercise improves the endothelial function.'}, {'measure': 'Measurement of inflammatory markers with exercise treatment or standard care', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, and 12 months', 'description': 'To identify whether 6 weeks of exercise therapy improves inflammatory markers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intermittent claudication', 'endothelial function', 'cardiopulmonary testing', 'inflammation', 'muscle architecture'], 'conditions': ['Intermittent Claudication', 'Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': "Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg?\n\nPurpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more.\n\nOne treatment for claudication is exercising until the pain comes onÍž which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown.\n\nThis project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens.\n\nMethods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community dwelling older adults aged 45 and over\n* Diagnosis of intermittent claudication - ABPI \\< 0.9 with symptoms in keeping with intermittent claudication\n* Undergoing surgery for claudication\n* Ability to walk without assistance\n* Healthy control patients who are undergoing varicose vein surgery\n\nExclusion Criteria:\n\n* Participants who are unable to provide informed consent\n* Severe of acute cardiovascular, musculoskeletal or pulmonary illness\n* Critical limb ischaemia\n* Active treatment for cancer\n* Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)\n* Failure to complete a CPET'}, 'identificationModule': {'nctId': 'NCT01980602', 'briefTitle': 'Effect of Exercise on Patients With Claudication Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Hull'}, 'officialTitle': 'A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants', 'orgStudyIdInfo': {'id': '11/YH/0210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised Exercise Program', 'interventionNames': ['Procedure: Supervised Exercise program']}], 'interventions': [{'name': 'Supervised Exercise program', 'type': 'PROCEDURE', 'armGroupLabels': ['Supervised Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU3 2JZ', 'city': 'Hull', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Romesh Sarvanandan, MBBS MRCS', 'role': 'CONTACT', 'email': 'romesh1985@doctors.org.uk', 'phone': '01482674643'}, {'name': 'Romesh Sarvanandan, MBBS MRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'centralContacts': [{'name': 'Romesh Sarvanandan, MBBS MRCS', 'role': 'CONTACT', 'email': 'romesh1985@doctors.org.uk', 'phone': '01482674643'}], 'overallOfficials': [{'name': 'Romesh Sarvanandan, MBBS MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hull', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Clinical Lecturer', 'investigatorFullName': 'Daniel Carradice', 'investigatorAffiliation': 'University of Hull'}}}}