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Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)

INTRODUCTION: Peripheral arterial disease (PAD) is a marker of cardiovascular morbidity, causing disability, loss of mobility and poor quality of life, manifesting clinically in the form of intermittent claudication (IC). Physical exercise increases the distance walked and improves quality of life....

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Autores principales: Alzamora, Maria Teresa, Forés, Rosa, Serra, Noemi, Martinez, Esau, Pera, Guillem, Seda, Gemma, Lopez Palencia, Joan, Gomis, Manuel, Heras Tébar, Antonio, Valverde, Marta, Garnacho, Manuel Vicente, Torán, Pere
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9047770/
https://www.ncbi.nlm.nih.gov/pubmed/35477870
http://dx.doi.org/10.1136/bmjopen-2021-054352
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author Alzamora, Maria Teresa
Forés, Rosa
Serra, Noemi
Martinez, Esau
Pera, Guillem
Seda, Gemma
Lopez Palencia, Joan
Gomis, Manuel
Heras Tébar, Antonio
Valverde, Marta
Garnacho, Manuel Vicente
Torán, Pere
author_facet Alzamora, Maria Teresa
Forés, Rosa
Serra, Noemi
Martinez, Esau
Pera, Guillem
Seda, Gemma
Lopez Palencia, Joan
Gomis, Manuel
Heras Tébar, Antonio
Valverde, Marta
Garnacho, Manuel Vicente
Torán, Pere
author_sort Alzamora, Maria Teresa
collection PubMed
description INTRODUCTION: Peripheral arterial disease (PAD) is a marker of cardiovascular morbidity, causing disability, loss of mobility and poor quality of life, manifesting clinically in the form of intermittent claudication (IC). Physical exercise increases the distance walked and improves quality of life. The aim of our study will be increased walking distance prolonging the time of onset of pain in patients with symptomatic PAD (IC). METHODS AND ANALYSIS: This study will be performed in Mataró Hospital’s vascular surgery service and School of Health Sciences, TecnoCampus. This population comes from 15 primary healthcare centres ofNorth Barcelona, Spain (450 000 inhabitants). This study will be a four-group parallel, longitudinal, randomised controlled trial, blind to analysis. The main primary outcome of this study will be the improvement in pain-free walking distance. Others primary objectives are and improvement in functional status, quality of life and Ankle-Brachial Index (ABI). Secondary outcomes will be the analysis of cardiorespiratory fitness, evaluation of muscle fitness, determine the maintenance of primary objectives at 6 and 12 months. We will be included 124 patients (31 per group). The changes of the outcome (Barthel, SF-12, VascQOL-6, ABI) of the three intervention groups vs the control group at 3, 6 and 12 months will be compared, both continuously (linear regression) and categorically (logistic regression). A person who has not performed at least 75% of the training will be considered to have not completed the intervention. ETHICS AND DISSEMINATION: The study will be conducted according to the Declaration of Helsinki. It was approved by the Ethics Committee of the Research Institute Primary Health IDIAP Jordi Gol (20/035 P), Barcelona 6 October 2020. Informed consent will be obtained from all patients before the start of the study. We will disseminate results through academic papers and conference presentations. TRIAL REGISTRATION NUMBER: NCT04578990.
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spelling pubmed-90477702022-05-11 Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study) Alzamora, Maria Teresa Forés, Rosa Serra, Noemi Martinez, Esau Pera, Guillem Seda, Gemma Lopez Palencia, Joan Gomis, Manuel Heras Tébar, Antonio Valverde, Marta Garnacho, Manuel Vicente Torán, Pere BMJ Open Cardiovascular Medicine INTRODUCTION: Peripheral arterial disease (PAD) is a marker of cardiovascular morbidity, causing disability, loss of mobility and poor quality of life, manifesting clinically in the form of intermittent claudication (IC). Physical exercise increases the distance walked and improves quality of life. The aim of our study will be increased walking distance prolonging the time of onset of pain in patients with symptomatic PAD (IC). METHODS AND ANALYSIS: This study will be performed in Mataró Hospital’s vascular surgery service and School of Health Sciences, TecnoCampus. This population comes from 15 primary healthcare centres ofNorth Barcelona, Spain (450 000 inhabitants). This study will be a four-group parallel, longitudinal, randomised controlled trial, blind to analysis. The main primary outcome of this study will be the improvement in pain-free walking distance. Others primary objectives are and improvement in functional status, quality of life and Ankle-Brachial Index (ABI). Secondary outcomes will be the analysis of cardiorespiratory fitness, evaluation of muscle fitness, determine the maintenance of primary objectives at 6 and 12 months. We will be included 124 patients (31 per group). The changes of the outcome (Barthel, SF-12, VascQOL-6, ABI) of the three intervention groups vs the control group at 3, 6 and 12 months will be compared, both continuously (linear regression) and categorically (logistic regression). A person who has not performed at least 75% of the training will be considered to have not completed the intervention. ETHICS AND DISSEMINATION: The study will be conducted according to the Declaration of Helsinki. It was approved by the Ethics Committee of the Research Institute Primary Health IDIAP Jordi Gol (20/035 P), Barcelona 6 October 2020. Informed consent will be obtained from all patients before the start of the study. We will disseminate results through academic papers and conference presentations. TRIAL REGISTRATION NUMBER: NCT04578990. BMJ Publishing Group 2022-04-26 /pmc/articles/PMC9047770/ /pubmed/35477870 http://dx.doi.org/10.1136/bmjopen-2021-054352 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Cardiovascular Medicine
Alzamora, Maria Teresa
Forés, Rosa
Serra, Noemi
Martinez, Esau
Pera, Guillem
Seda, Gemma
Lopez Palencia, Joan
Gomis, Manuel
Heras Tébar, Antonio
Valverde, Marta
Garnacho, Manuel Vicente
Torán, Pere
Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
title Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
title_full Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
title_fullStr Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
title_full_unstemmed Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
title_short Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
title_sort supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (artperfit study)
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9047770/
https://www.ncbi.nlm.nih.gov/pubmed/35477870
http://dx.doi.org/10.1136/bmjopen-2021-054352
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