Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
Por:
Alzamora, MT, Fores, R, Serra, N, Martinez, E, Pera, G, Seda, G, Palencia, JL, Gomis, M, Tebar, AH, Valverde, M, Garnacho, MV and Toran, P
Publicada:
1 abr 2022
Resumen:
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 Mataro Hospital's vascular surgery service and School of Health Sciences, TecnoCampus. This population comes from 15 primary healthcare centres of North 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.
Filiaciones:
:
Inst Catala La Salut, Family Med Riu Nord Riu Sud, Santa Coloma De Gramenet, Spain
IDIAP Jordi Gol, USR Metropolitana Nord, Barcelona, Spain
:
IDIAP Jordi Gol, USR Metropolitana Nord, Barcelona, Spain
Inst Catala Salut, Family Med Riu Nord Riu Sud, Barcelona, Spain
Serra, N:
Univ Pompeu Fabra, Escola Super Politecn, TecnoCampus, Mataro, Spain
Martinez, E:
Hosp Mataro, Vasc Surg, Mataro, Spain
Pera, G:
IDIAP Jordi Gol, USR Metropolitana Nord Mataro, Barcelona, Spain
Seda, G:
Inst Catala Salut, Barcelona, Spain
Palencia, JL:
Hosp Mataro, Vasc Surg, Mataro, Spain
Gomis, M:
Univ Pompeu Fabra, Escola Super Politecn, TecnoCampus, Mataro, Spain
:
IDIAP Jordi Gol, USR Metropolitana Nord, Barcelona, Spain
Inst Catala Salut, Primary Healthcare Ctr Riu Nord Riu SUD, Barcelona, Spain
Valverde, M:
Hosp Nostra Senyora Meritxell, Escaldes Engordany, Andorra
Garnacho, MV:
Univ Pompeu Fabra, Escola Super Ciencies Salut, TecnoCampus, Mataro, Spain
Toran, P:
Inst Catala Salut, Unitat Suport Recerca Metropolitana Nord, Barcelona, Spain
Green Published, gold
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