Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Ankle-Brachial Index (ABI)
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with a peripheral arterial disease with symptoms of intermittent claudication
- •Age\> 40 years
- •Signing of the informed consent to participate in the study
Exclusion Criteria
- •Critical ischemia and/or acute lower extremity ischemia
- •Previous bilateral lower extremity revascularization.
- •Lower limb amputation
- •Major surgery in the previous 3 months or scheduled in the next year
- •Cardiovascular, pulmonary, neurological and osteoarticular diseases that prevent the performance of the intervention.
- •The appearance of intermittent claudication 30-45 minutes after the start of a claudication.
- •Inability to go to the centre due to lack of time or limiting illness
- •To participate, subjects must obtain medical consent to participate in a physical exercise intervention.
Outcomes
Primary Outcomes
Ankle-Brachial Index (ABI)
Time Frame: 6 months from the start of the study
To know if the proposed training programs improve the ankle-brachial index.
General functional state
Time Frame: 6 months from the start of the study
General functional state using the Barthel questionnaire.
Pain-free walking distance
Time Frame: 6 months from the start of the study
Pain-free walking distance using the 6-minute walk test distance
Perceived quality of life level
Time Frame: 6 months from the start of the study
Perceived quality of life level
Secondary Outcomes
- Ankle-Brachial Index in the long term(12 months from the start of the study)
- Keep exercising in the long term(12 months from the start of the study)
- Severity of peripheral arterial disease(3 and 6 months from the start of the study)
- Maintenance of objective in the long term(12 months from the start of the study)