Effect of Exercise on Patients With Claudication Undergoing Surgery

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01980602
• Other study ID #: 11/YH/0210
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2013
• Last updated: November 4, 2013
• Start date: March 2011

Study information

• Verified date: November 2013
• Source: University of Hull
• Contact: Romesh Sarvanandan, MBBS MRCS
• Phone: 01482674643
• Email: romesh1985[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: UK Research Ethics Committee: Bradford, England
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Supervised Exercise program

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull

Sponsors (1)

Lead Sponsor	Collaborator
University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No