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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

Tracking Information
First Submitted Date  ICMJE September 22, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date October 14, 2020
Estimated Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • Pain-free walking distance [ Time Frame: 3 months from the start of the study ]
    Pain-free walking distance using Treadmill based walking
  • Pain-free walking distance [ Time Frame: 6 months from the start of the study ]
    Pain-free walking distance using Treadmill based walking
  • 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
  • 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
  • General functional state [ Time Frame: 3 months from the start of the study ]
    General functional state using the Barthel questionnaire.
  • General functional state [ Time Frame: 6 months from the start of the study ]
    General functional state using the Barthel questionnaire.
  • Perceived quality of life level [ Time Frame: 3 months from the start of the study ]
    Perceived quality of life level
  • Perceived quality of life level [ Time Frame: 6 months from the start of the study ]
    Perceived quality of life level
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ARTPERfit Clinical Trial.
Official Title  ICMJE Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Peripheral Arterial Disease
  • Arteriosclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Walking intervention
  • Experimental: Strength intervention group
    The training program consists of performing a training program with resistance exercises for 36-72 weeks.
    Intervention: Other: Strength intervention
  • 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.
    Intervention: Other: Concurrent intervention
  • No Intervention: Control group
    It will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2020)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2023
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria Teresa Alzamora Sas, MD and PhD 0034649560266 maiteal2007@gmail.com
Contact: Gemma Seda Gombau, PhD 0034662234558 gemma.seda.ics@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04578990
Other Study ID Numbers  ICMJE PI20/00129
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jordi Gol i Gurina Foundation
Study Sponsor  ICMJE Jordi Gol i Gurina Foundation
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
Principal Investigator: Maria Teresa Alzamora Sas, MD and PhD Institut Català de la Salut
PRS Account Jordi Gol i Gurina Foundation
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP