Effect of Exercise on Patients With Claudication Undergoing Surgery

NCT01980602 | Unknown

• 1 other identifier: 11/YH/0210
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg? 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 on; 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.

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Keywords

Intermittent claudication; endothelial function; cardiopulmonary testing; inflammation; muscle architecture

Outcome Measures

Primary Outcomes (1)

• Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care

  Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness

  6 weeks

Secondary Outcomes (3)

• Measure the changes in muscle fibre type with exercise training or standard care

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• Measurement of endothelial function after a period or exercise therapy or standard care

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• Measurement of inflammatory markers with exercise treatment or standard care

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

Study Arms (1)

Supervised Exercise Program

EXPERIMENTAL

Procedure: Supervised Exercise program

Interventions

Supervised Exercise program PROCEDURE

Supervised Exercise Program

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community dwelling older adults aged 45 and over
• 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

You may not qualify if:

• Participants who are unable to provide informed consent
• 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

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease; Inflammation

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes

Study Officials

• Romesh Sarvanandan, MBBS MRCS

  Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romesh Sarvanandan, MBBS MRCS

CONTACT

01482674643; romesh1985@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Clinical Lecturer

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: November 11, 2013
• Study Start: March 1, 2011
• Primary Completion: July 1, 2016
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

GB (1)