Peripheral Arterial Disease Clinical Trial
Official title:
Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
Peripheral arterial disease is part of the diseases derived from arteriosclerosis are the
leading cause of mortality in developed countries. There is evidence of the benefits of
physical exercise programs supervised in patients with cardiovascular risk. Despite being a
treatment with proven efficacy and relatively inexpensive, it continues being little used for
the management of patients with intermittent claudication caused by peripheral arterial
disease.
The objective of this study is to develop an evidence-based intervention strategy on the
effectiveness of supervised physical exercise in intermittent claudication to determine its
impact compared to standard counselling in these patients.
Peripheral arterial disease is part of the diseases derived from arteriosclerosis, such as
myocardial infarction or stroke. These entities are the leading cause of mortality in
developed countries. The peripheral arterial disease is a narrowing of the diameter of the
arteries in the legs due to plaque formation of atheroma. When the obstruction is significant
enough, there is a decrease in blood flow to the musculature of the lower limbs and
consequently, depending on the severity of the narrowing, we can find from asymptomatic
patients to patients with atrophic lesions, going through different degrees of pain when
walking or at rest.
It is estimated that in 2010 more than 200 million people had peripheral arterial disease
worldwide, with symptoms that range from mild to severe. The forecast is heading towards an
increase in prevalence due to the increase in the life span of the world population and
cardiovascular risk factors.
There is evidence in countries with high cardiovascular risk regarding the benefit obtained
in physical exercise programs supervised in patients with pain when walking, both in
increasing the distance walked and in prolonging at the time of onset of pain. Despite being
a treatment with proven efficacy and relatively inexpensive, it continues being little used
for the management of patients with intermittent claudication caused by arteriopathy in
Spain.
This project aims to assess the effectiveness of various supervised physical exercise
programs in patients with Symptomatic Peripheral Artery Disease (Intermittent Claudication)
versus single advice to exercise without supervision. After a first initial assessment visit,
four groups will be formed at random. A control group who will be given standard advice to
perform physical exercise and three experimental intervention groups. They will be assessed
at 3 and 6 months after performing sessions of supervised exercise lasting one hour 3 times a
week and 12 months after the initial visit, (after 6 months of end supervised exercise
sessions). The impact in terms of changes in quality of life will also be evaluated.
In the longer term, and depending on the results obtained, it is intended to implement a
similar intervention, at the level of primary care, or as close as possible to the place of
residence of this type of patient to facilitate the performance of the exercise, improve the
symptoms and quality of life of these patients
;
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