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ARTPERfit Clinical Trial. (ARTPERfit)

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ClinicalTrials.gov Identifier: NCT04578990
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Arteriosclerosis Other: Walking intervention Other: Strength intervention Other: Concurrent intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: Analysis masking
Primary Purpose: Treatment
Official Title: Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Walking intervention group
It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly.
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.


Experimental: Strength intervention group
The training program consists of performing a training program with resistance exercises for 36-72 weeks.
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.

Experimental: Concurrent intervention group
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.
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.

No Intervention: Control group
It will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level.



Primary Outcome Measures :
  1. Pain-free walking distance [ Time Frame: 3 months from the start of the study ]
    Pain-free walking distance using Treadmill based walking

  2. Pain-free walking distance [ Time Frame: 6 months from the start of the study ]
    Pain-free walking distance using Treadmill based walking

  3. Pain-free walking distance [ Time Frame: 3 months from the start of the study ]
    Pain-free walking distance using the 6-minute walk test distance

  4. Pain-free walking distance [ Time Frame: 6 months from the start of the study ]
    Pain-free walking distance using the 6-minute walk test distance

  5. General functional state [ Time Frame: 3 months from the start of the study ]
    General functional state using the Barthel questionnaire.

  6. General functional state [ Time Frame: 6 months from the start of the study ]
    General functional state using the Barthel questionnaire.

  7. Perceived quality of life level [ Time Frame: 3 months from the start of the study ]
    Perceived quality of life level

  8. Perceived quality of life level [ Time Frame: 6 months from the start of the study ]
    Perceived quality of life level

  9. Ankle-Brachial Index (ABI) [ Time Frame: 3 months from the start of the study ]
    To know if the proposed training programs improve the ankle-brachial index.

  10. Ankle-Brachial Index (ABI) [ Time Frame: 6 months from the start of the study ]
    To know if the proposed training programs improve the ankle-brachial index.


Secondary Outcome Measures :
  1. Maintenance of objective in the long term [ Time Frame: 12 months from the start of the study ]
    Determine the maintenance of objectives 1, 2 and 3, 6 months after completing the intervention

  2. Keep exercising in the long term [ Time Frame: 12 months from the start of the study ]
    To know the proportion of subjects who continue to exercise 6 months after completing the study

  3. Severity of peripheral arterial disease [ Time Frame: 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.

  4. Ankle-Brachial Index in the long term [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578990


Contacts
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Contact: Maria Teresa Alzamora Sas, MD and PhD 0034649560266 maiteal2007@gmail.com
Contact: Gemma Seda Gombau, PhD 0034662234558 gemma.seda.ics@gmail.com

Locations
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Spain
Unitat de Suport a la Recerca (Metropolitana Nord)
Mataró, Barcelona, Spain, 08303
Contact: Maria Teresa Alzamora Sas, MD and PhD    0034649560266    maiteal2007@gmail.com   
Contact: Gemma s Seda Gombau, PhD    0034662234558    gemma.seda.ics@gmail.com   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Maria Teresa Alzamora Sas, MD and PhD Institut Català de la Salut
Publications:
Mostaza JM, Puras E, Blasco M, et al. Utilización de tratamientos cardiovasculares preventivos y consecución de objetivos terapéuticos en pacientes con enfermedad arterial periférica. Rev Esp Cardiol. 2012;65:713 -8.
F.S.Lozano Sánchez, J.R March García E Carrasco Carrasco. Profile of patients with intermittent claudication in Spain. The VITAL Study. Angiologia. 2013;65:131-140

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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT04578990    
Other Study ID Numbers: PI20/00129
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
Peripheral Arterial Disease
Physical Activity
Intermittent Claudication
Cardiovascular Disease
Ankle Brachial Index
Treadmill Test
Resistance Training
Functional Decline
Quality of Life
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases