Effect of Exercise on Patients With Claudication Undergoing Surgery
NCT ID: NCT01980602
Last Updated: 2013-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2011-03-31
Brief Summary
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Purpose 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.
One 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.
This 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.
Methods: 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Supervised Exercise Program
Supervised Exercise program
Interventions
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Supervised Exercise program
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of intermittent claudication - ABPI \< 0.9 with symptoms in keeping with intermittent claudication
* Undergoing surgery for claudication
* Ability to walk without assistance
* Healthy control patients who are undergoing varicose vein surgery
Exclusion Criteria
* Severe of acute cardiovascular, musculoskeletal or pulmonary illness
* Critical limb ischaemia
* Active treatment for cancer
* Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)
* Failure to complete a CPET
45 Years
ALL
Yes
Sponsors
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University of Hull
OTHER
Responsible Party
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Daniel Carradice
Academic Clinical Lecturer
Principal Investigators
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Romesh Sarvanandan, MBBS MRCS
Role: PRINCIPAL_INVESTIGATOR
Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
Locations
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Hull Royal Infirmary
Hull, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Romesh Sarvanandan, MBBS MRCS
Role: primary
Other Identifiers
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11/YH/0210
Identifier Type: -
Identifier Source: org_study_id