Effect of Exercise on Patients With Claudication Undergoing Surgery

A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Intervention / Treatment: Procedure: Supervised Exercise program

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull Royal Infirmary
    • Contact: Romesh Sarvanandan, MBBS MRCS; Phone Number: 01482674643; Email: romesh1985@doctors.org.uk
    • Principal Investigator: Romesh Sarvanandan, MBBS MRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised Exercise Program	Procedure: Supervised Exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the changes in muscle fibre type with exercise training or standard care	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.	Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of endothelial function after a period or exercise therapy or standard care	To identify if 6 weeks of exercise improves the endothelial function.	Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of inflammatory markers with exercise treatment or standard care	To identify whether 6 weeks of exercise therapy improves inflammatory markers	Baseline, 6 weeks, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: University of Hull
• Investigators: Principal Investigator: Romesh Sarvanandan, MBBS MRCS, Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Estimate): November 11, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: muscle architecture; inflammation; endothelial function; cardiopulmonary testing; Intermittent claudication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 11/YH/0210