ARTPERfit Clinical Trial.
- Conditions
- Peripheral Arterial DiseaseArteriosclerosis
- Interventions
- Other: Strength interventionOther: Walking interventionOther: Concurrent intervention
- Registration Number
- NCT04578990
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
- Subjects with a peripheral arterial disease with symptoms of intermittent claudication
- Age> 40 years
- Signing of the informed consent to participate in the study
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strength intervention group Strength intervention The training program consists of performing a training program with resistance exercises for 36-72 weeks. Walking intervention group Walking intervention It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly. Concurrent intervention group Concurrent intervention The training program consists of alternating strength and resistance stimuli in the same session for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied for 35 minutes and to complete the 60 minutes, the same guidelines will be followed as in the walking exercise, applying resistance stimuli.
- Primary Outcome Measures
Name Time Method Ankle-Brachial Index (ABI) 6 months from the start of the study To know if the proposed training programs improve the ankle-brachial index.
General functional state 6 months from the start of the study General functional state using the Barthel questionnaire.
Pain-free walking distance 6 months from the start of the study Pain-free walking distance using the 6-minute walk test distance
Perceived quality of life level 6 months from the start of the study Perceived quality of life level
- Secondary Outcome Measures
Name Time Method Ankle-Brachial Index in the long term 12 months from the start of the study Analyze the changes in the ankle-brachial index at 12 months from the start of the study.
Keep exercising in the long term 12 months from the start of the study To know the proportion of subjects who continue to exercise 6 months after completing the study
Severity of peripheral arterial disease 3 and 6 months from the start of the study Determine objectives 1, 2 and 3 concerning the severity of peripheral arterial disease (according to baseline ABI) at 3 and 6 months of an exercise program supervised physicist.
Maintenance of objective in the long term 12 months from the start of the study Determine the maintenance of objectives 1, 2 and 3, 6 months after completing the intervention
Trial Locations
- Locations (1)
Unitat de Suport a la Recerca (Metropolitana Nord)
🇪🇸Mataró, Barcelona, Spain