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

NACompletedINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Femoropopliteal DiseaseIntermittent 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.

Trial Locations (1)

HU3 2JZ

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

All Listed Sponsors
collaborator

University of Hull

OTHER

lead

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

NCT00798850 - Trial of Nonsurgical Treatment of Intermittent Claudication Due to Femoro-popliteal Disease | Biotech Hunter | Biotech Hunter