Trial of Nonsurgical Treatment of Intermittent Claudication Due to Femoro-Popliteal Disease - Full Text View

Sponsors and Collaborators:	University of Hull Hull & East Yorkshire Hospital NHS Trust British Journal of Surgery Research Grant European Society of Vascular Surgery Research Grant
Information provided by:	University of Hull
ClinicalTrials.gov Identifier:	NCT00798850

Purpose

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.

Condition	Intervention
Femoropopliteal Disease Intermittent Claudication	Procedure: Percutaneous Transluminal Angioplasty (PTA) Procedure: Supervised Exercise Programme (SEP) Procedure: Combined Treatment

MedlinePlus related topics: Angioplasty Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Randomised Controlled Trial of Percutaneous Transluminal Angioplasty (PTA) Versus a Supervised Exercise Programme (SEP) in the Management of Intermittent Claudication (IC) Due to Femoro-Popliteal Disease

Further study details as provided by University of Hull:

Primary Outcome Measures:

Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) [ Time Frame: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment ] [ Designated as safety issue: No ]
Ankle brachial pressure indices(ABPI) measured at rest and post exercise [ Time Frame: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Reported Walking Distances (PRWD) [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ] [ Designated as safety issue: No ]
Clinical outcomes(PTA patency,re-intervention rates, fatal&non-fatal events,amputation,mortality and ISCVS outcome) [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ] [ Designated as safety issue: No ]
Health economic analyses [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ] [ Designated as safety issue: No ]
Markers of ischaemia reperfusion [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ] [ Designated as safety issue: No ]
Heat-shock proteins [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment. ] [ Designated as safety issue: No ]

Enrollment:	178
Study Start Date:	August 2002
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PTA: Active Comparator	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.
SEP: Active Comparator	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). Station 1-Step-ups(20-cm high step,alternating leg after 10 step-ups) Station 2-Exercise bicycles Station 3-Knee extensions with weights(2kg beanbag) Station 4-Heel raises Station 5-Knee bends(Alternating legs after 10 bends) 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.
PTA+SEP: Active Comparator	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.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptomatic unilateral Intermittent Claudication Femoro-popliteal lesion Angioplastiable lesion on duplex > 3 months on BMT

Exclusion Criteria:

Critical ischaemia Incapacitating systemic disease Inability to tolerate treadmill testing Ischaemic changes on ECG during treadmill testing Ipsilateral surgery / PTA in previous 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798850

Locations

United Kingdom, East Riding of Yorkshire
Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary
Hull, East Riding of Yorkshire, United Kingdom, HU3 2JZ

Sponsors and Collaborators

University of Hull

Hull & East Yorkshire Hospital NHS Trust

British Journal of Surgery Research Grant

European Society of Vascular Surgery Research Grant

Investigators

Principal Investigator:

Peter T McCollum, FRCS

Academic Vascular Surgery Unit, University of Hull

More Information

Publications:

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Responsible Party:	Academic Vascular Surgery Unit, University of Hull ( Mr. Fayyaz Mazari / Clinical Research Officer )
Study ID Numbers:	HEY- REF-2424
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798850
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Department of Health; United Kingdom: National Health Service

Keywords provided by University of Hull:

Claudication
Vascular claudication
Peripheral Vascular Disease
Peripheral arterial disease
Peripheral arterial occlusive disease
Angioplasty
Femoral angioplasty
Superficial femoral artery
Femoral arterial disease
Exercise
Supervised exercise

Exercise therapy
Exercise programme
Infrainuginal
Quality of life
SF36
Questionnaire
VascuQol
Randomised
Randomised trial
Combination therapy
Intermittent Claudication due to Femoropopliteal Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Signs and Symptoms
Peripheral Vascular Diseases
Vascular Diseases

Quality of Life
Intermittent Claudication
Arteriosclerosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009