ARTPERfit Clinical Trial.

Peripheral Arterial Disease Clinical Trial

— ARTPERfit  

Official title:

Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04578990
• Other study ID #: PI20/00129
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2020
• Source: Jordi Gol i Gurina Foundation
• Contact: Maria Teresa Alzamora Sas, MD and PhD
• Phone: 0034649560266
• Email: maiteal2007[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: August 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Unitat de Suport a la Recerca (Metropolitana Nord)	Mataró	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (29)

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Alzamora MT, Forés R, Pera G, Torán P, Heras A, Sorribes M, Baena-Diez JM, Urrea M, Alegre J, Viozquez M, Vela C. Ankle-brachial index and the incidence of cardiovascular events in the Mediterranean low cardiovascular risk population ARTPER cohort. BMC Cardiovasc Disord. 2013 Dec 17;13:119. doi: 10.1186/1471-2261-13-119. — View Citation

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Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1. Review. — View Citation

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McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962. Erratum in: JAMA. 2012 Apr 25;307(16):1694. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-free walking distance	Pain-free walking distance using Treadmill based walking	3 months from the start of the study
Primary	Pain-free walking distance	Pain-free walking distance using Treadmill based walking	6 months from the start of the study
Primary	Pain-free walking distance	Pain-free walking distance using the 6-minute walk test distance	3 months from the start of the study
Primary	Pain-free walking distance	Pain-free walking distance using the 6-minute walk test distance	6 months from the start of the study
Primary	General functional state	General functional state using the Barthel questionnaire.	3 months from the start of the study
Primary	General functional state	General functional state using the Barthel questionnaire.	6 months from the start of the study
Primary	Perceived quality of life level	Perceived quality of life level	3 months from the start of the study
Primary	Perceived quality of life level	Perceived quality of life level	6 months from the start of the study
Primary	Ankle-Brachial Index (ABI)	To know if the proposed training programs improve the ankle-brachial index.	3 months from the start of the study
Primary	Ankle-Brachial Index (ABI)	To know if the proposed training programs improve the ankle-brachial index.	6 months from the start of the study
Secondary	Maintenance of objective in the long term	Determine the maintenance of objectives 1, 2 and 3, 6 months after completing the intervention	12 months from the start of the study
Secondary	Keep exercising in the long term	To know the proportion of subjects who continue to exercise 6 months after completing the study	12 months from the start of the study
Secondary	Severity of peripheral arterial disease	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.	3 and 6 months from the start of the study
Secondary	Ankle-Brachial Index in the long term	Analyze the changes in the ankle-brachial index at 12 months from the start of the study.	12 months from the start of the study