Comparing Exercise Training and Angioplasty for Claudication:
a Randomized Controlled Trial.

There remains still uncertainty surrounding the effectiveness of the treatment strategies in patients with intermittent claudication. Therefore, the proposed study will evaluate the relative impacts of hospital-based exercise training versus percutaneous transluminal angioplasty in patients with iliac and femoro-popliteal vascular pathology on the quality of life and the functional capacity after 6 months and 12 months follow up.

The proposed study will evaluate the relative impacts of exercise training versus percutaneous transluminal angioplasty in patients with iliac and femoro-popliteal vascular pathology on the quality of life and the maximum painless walking distance (MPWD) after 6 months and one year follow up.

N/A

Percutaneous transluminal angioplasty:

PTA is an invasive procedure with catheterisation and digital subtraction angiography (DSA). The procedure requires an arterial puncture and a 4-6 hour period of bed rest when it is finished.
Patients are invited to the department of radiology. PTA will be performed using a conventional guidewire and balloon catheter technique. The lumen of the stenotic or occluded artery has to be overdilated by 10% above normal. If the pressure measurement shows a successful result (no pressure gradient of more than 15% or < 10-15 mm Hg), a post-procedural angiography will be performed to show morphologic success. Intra-arterial iodinated contrast is administered through the catheter, as well as heparine.

Post-procedural Ascal therapy (100 mg per day) will be given for the remaining lifetime.




Hospital–based Exercise:

Hospital-based exercise is a non-invasive treatment and will be conducted twice a week, 30 minutes each session, on a walking treadmill during 24 weeks. Each training session will be supervised by a vascular technician.
Walking treadmill exercise will be initiated at a low treadmill work load of 3.5 km/h, 0% grade. Patients walk until claudication pain occurs, at which time patients will rest until the pain subsides.
Exercise and rest periods are repeated throughout each training session. If a patient is able to walk 8-10 minutes at the initial work load, the grade will be increased by 1-2% or the speed will be increased by 0.5 km/h as tolerated.
If the MPWD does not improve, the vascular technician should try to find the possible cause (e.g. insufficient training, bad condition) and the patient has to be motivated to continue the training programme.

All patients are instructed to walk for at least 30 minutes three times a week outside the hospital setting.