ARTPERfit Clinical Trial.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Arteriosclerosis; Peripheral Arterial Disease

Treatments: Other: Concurrent intervention; Other: Strength intervention; Other: Walking intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04578990

PI20/00129

Details and patient eligibility

About

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.

Full 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

Enrollment: 124 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 4 patient groups

Walking intervention group

Experimental group

Description:

It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly.

Treatment:

Other: Walking intervention

Strength intervention group

Experimental group

Description:

The training program consists of performing a training program with resistance exercises for 36-72 weeks.

Treatment:

Other: Strength intervention

Concurrent intervention group

Experimental group

Description:

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.

Treatment:

Other: Concurrent intervention

Control group

No Intervention group

Description:

It will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level.