Effect of Exercise on Patients With Claudication Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01980602
Recruitment Status : Unknown
Verified November 2013 by Daniel Carradice, University of Hull.
Recruitment status was:  Recruiting
First Posted : November 11, 2013
Last Update Posted : November 11, 2013
Information provided by (Responsible Party):
Daniel Carradice, University of Hull

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.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Peripheral Arterial Disease Procedure: Supervised Exercise program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
Study Start Date : March 2011
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Supervised Exercise Program Procedure: Supervised Exercise program

Primary Outcome Measures :
  1. Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care [ Time Frame: 6 weeks ]
    Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness

Secondary Outcome Measures :
  1. Measure the changes in muscle fibre type with exercise training or standard care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months ]
    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.

  2. Measurement of endothelial function after a period or exercise therapy or standard care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months ]
    To identify if 6 weeks of exercise improves the endothelial function.

  3. Measurement of inflammatory markers with exercise treatment or standard care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months ]
    To identify whether 6 weeks of exercise therapy improves inflammatory markers

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01980602

Contact: Romesh Sarvanandan, MBBS MRCS 01482674643

United Kingdom
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Romesh Sarvanandan, MBBS MRCS    01482674643   
Principal Investigator: Romesh Sarvanandan, MBBS MRCS         
Sponsors and Collaborators
University of Hull
Principal Investigator: Romesh Sarvanandan, MBBS MRCS Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust

Responsible Party: Daniel Carradice, Academic Clinical Lecturer, University of Hull Identifier: NCT01980602     History of Changes
Other Study ID Numbers: 11/YH/0210
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Keywords provided by Daniel Carradice, University of Hull:
Intermittent claudication
endothelial function
cardiopulmonary testing
muscle architecture

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms