Trial of Nonsurgical Treatment of Intermittent Claudication Due to Femoro-popliteal Disease

Summary

Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of the legs on exertion caused by "hardening of the arteries" and a reduced blood supply. The investigators know that the vast majority of people suffering from this condition remain stable and do not deteriorate, and thus in general the viability of legs is not at risk. The main aim of treatment, therefore, is to try and improve walking thus reducing the impact this problem has on patients life style. There are many methods of management of intermittent claudication, but the investigators do not know which produces the best results. This study aims to compare the short and medium term outcomes of exercise programmes, percutaneous transluminal angioplasty and a combination of the two treatments for patients with intermittent claudication.

Conditions

• Femoropopliteal Disease
• Intermittent Claudication

Interventions

PROCEDURE

Percutaneous Transluminal Angioplasty (PTA)

PTA will be performed by a consultant interventional radiologist with no deviation from the standard protocol at Hull \& East Yorshire Yospitals NHS Trust.

PROCEDURE

Supervised Exercise Programme (SEP)

SEP: Conducted 3 times per week for 12 weeks.The session will be supervised by a physiotherapist and conducted in the cardiac gym. Each session begins with gentle warming up exercises followed by an exercise circuit of 6 stations(2 minutes each). 1. Station 1-Step-ups(20-cm high step,alternating leg after 10 step-ups) 2. Station 2-Exercise bicycles 3. Station 3-Knee extensions with weights(2kg beanbag) 4. Station 4-Heel raises 5. Station 5-Knee bends(Alternating legs after 10 bends) 6. Station 6-Rest station(2Kg Biceps curls) Gentle walk for 2minutes in between the stations to recover.For first 6weeks patients complete one full circuit, followed by on extra station/week, thus by 12weeks patients will complete 2 full circuits.Finally patients perform a series of gentle stretching and cooling down exercises. This exercise programme was designed to comply with suggested guidelines based on a meta-analysis assessing the effectiveness of SEP for claudicants.

PROCEDURE

Combined Treatment

PTA will be performed according to routine protocol followed by enrollment of patient in SEP. SEP will commence in the week following PTA.

Sponsors & Collaborators

• University of Hull

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  lead OTHER_GOV

Principal Investigators

• Peter T McCollum, FRCS · Academic Vascular Surgery Unit, University of Hull

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-08-31

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• United Kingdom

Study Locations