ARTPERfit Clinical Trial.

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.

Conditions

• Peripheral Arterial Disease
• Arteriosclerosis

Interventions

OTHER

Walking intervention

It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly. Depending on the data obtained in Visit 1, the speed will be determined for each patient and the degree of the initial slope that is comfortable when walking until it induces symptoms of moderate intermittent claudication. The progression of the intensity of the speed and incline of the slope will be increased progressively and individually for each patient.

OTHER

Strength intervention

The training program consists of performing a training program with resistance exercises for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied. The same guidelines will be followed as in the walking exercise, but in this case, applying force stimuli. If symptoms of moderate intermittent claudication occur (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain disappears at the level of the lower limb. This sequence will be repeated until the strength training session is completed. The progression of force stimuli will be increased weekly depending on the subjective perception of the patient's effort and according to the guidelines set by our group of investigation.

OTHER

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. If claudication symptoms occur moderate intermittent (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain in the lower extremity disappears. This sequence will be repeated until the 20 minutes established to end the session are completed concurrent training. The progression of the strength and resistance stimuli will be increased weekly depending on the perception subjective effort of the patient and according to the guidelines established by our research group.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  lead OTHER

Principal Investigators

• Maria Teresa Alzamora Sas, MD and PhD · Institut Català de la Salut

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-07-30

Completion

2023-08-30

Countries

• Spain

Study Locations