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

NCT00798850 | Completed

• 1 other identifier: HEY- REF-2424
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD)

  Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment

• Ankle brachial pressure indices(ABPI) measured at rest and post exercise

  Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment

Secondary Outcomes (5)

• Patient Reported Walking Distances (PRWD)

  Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment

• Clinical outcomes(PTA patency,re-intervention rates, fatal&non-fatal events,amputation,mortality and ISCVS outcome)

  Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment

• Health economic analyses

  Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment

• Markers of ischaemia reperfusion

  Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment

• Heat-shock proteins

  Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment.

Study Arms (3)

PTA

ACTIVE COMPARATOR

Procedure: Percutaneous Transluminal Angioplasty (PTA)

SEP

ACTIVE COMPARATOR

Procedure: Supervised Exercise Programme (SEP)

PTA+SEP

ACTIVE COMPARATOR

Procedure: Combined Treatment

Interventions

Percutaneous Transluminal Angioplasty (PTA) PROCEDURE

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

PTA

Supervised Exercise Programme (SEP) PROCEDURE

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.

SEP

Combined Treatment PROCEDURE

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

PTA+SEP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

Location

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• Mazari FA, Gulati S, Rahman MN, Lee HL, Mehta TA, McCollum PT, Chetter IC. Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication. Ann Vasc Surg. 2010 Jan;24(1):69-79. doi: 10.1016/j.avsg.2009.07.005. Epub 2009 Sep 17.

  PMID: 19762206 RESULT

• Mazari FA, Carradice D, Rahman MN, Khan JA, Mockford K, Mehta T, McCollum PT, Chetter IC. An analysis of relationship between quality of life indices and clinical improvement following intervention in patients with intermittent claudication due to femoropopliteal disease. J Vasc Surg. 2010 Jul;52(1):77-84. doi: 10.1016/j.jvs.2010.01.085. Epub 2010 May 14.

  PMID: 20471779 RESULT

• Mazari FA, Khan JA, Carradice D, Samuel N, Abdul Rahman MN, Gulati S, Lee HL, Mehta TA, McCollum PT, Chetter IC. Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease. Br J Surg. 2012 Jan;99(1):39-48. doi: 10.1002/bjs.7710. Epub 2011 Oct 21.

  PMID: 22021102 RESULT

• Mazari FA, Khan JA, Carradice D, Samuel N, Gohil R, McCollum PT, Chetter IC. Economic analysis of a randomized trial of percutaneous angioplasty, supervised exercise or combined treatment for intermittent claudication due to femoropopliteal arterial disease. Br J Surg. 2013 Aug;100(9):1172-9. doi: 10.1002/bjs.9200.

  PMID: 23842831 RESULT

• Mazari FA, Khan JA, Samuel N, Smith G, Carradice D, McCollum PC, Chetter IC. Long-term outcomes of a randomized clinical trial of supervised exercise, percutaneous transluminal angioplasty or combined treatment for patients with intermittent claudication due to femoropopliteal disease. Br J Surg. 2017 Jan;104(1):76-83. doi: 10.1002/bjs.10324. Epub 2016 Oct 20.

  PMID: 27763685 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1; Motor Activity

Interventions

Angioplasty; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Behavior

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Peter T McCollum, FRCS

  Academic Vascular Surgery Unit, University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: August 1, 2002
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

GB (1)