Clinical trial NCT04578990: ARTPERfit Clinical Trial.
Official title: Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Arteriosclerosis
Keywords: Peripheral Arterial Disease
Physical Activity
Intermittent Claudication
Cardiovascular Disease
Ankle Brachial Index
Treadmill Test
Resistance Training
Functional Decline
Quality of Life
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2020-10-08
Enrollment: 124
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized longitudinal controlled trial, parallel, blinded to the analysis, with a sample of participants studied between 3 and 6 months after starting a physical exercise program. Participants will be randomly assigned to four groups. Intervention walking group: The intervention will consist of carrying out the walking training progression. The strength group will carry out a resistance training program. The concurrent training intervention group will carry out an exercise program that will alternate strength and endurance training in the same session. Both experimental groups will hold 36-72 sessions, with a frequency of 3 sessions per week and 60 minutes per session. The control group will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level warning.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pain-free walking distance
timeFrame: 3 months from the start of the study
measure: Pain-free walking distance
timeFrame: 6 months from the start of the study
measure: Pain-free walking distance
timeFrame: 3 months from the start of the study
measure: Pain-free walking distance
timeFrame: 6 months from the start of the study
measure: General functional state
timeFrame: 3 months from the start of the study
measure: General functional state
timeFrame: 6 months from the start of the study
measure: Perceived quality of life level
timeFrame: 3 months from the start of the study
measure: Perceived quality of life level
timeFrame: 6 months from the start of the study
measure: Ankle-Brachial Index (ABI)
timeFrame: 3 months from the start of the study
measure: Ankle-Brachial Index (ABI)
timeFrame: 6 months from the start of the study
Secondary outcomes:
measure: Maintenance of objective in the long term
timeFrame: 12 months from the start of the study
measure: Keep exercising in the long term
timeFrame: 12 months from the start of the study
measure: Severity of peripheral arterial disease
timeFrame: 3 and 6 months from the start of the study
measure: Ankle-Brachial Index in the long term
timeFrame: 12 months from the start of the study
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Unitat de Suport a la Recerca (Metropolitana Nord)
state: Barcelona
Study officials:
affiliation: Institut Català de la Salut
name: Maria Teresa Alzamora Sas, MD and PhD
role: PRINCIPAL_INVESTIGATOR
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