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Effects of arm-crank exercise on cardiovascular function, functional capacity, cognition and quality of life in patients with peripheral artery disease: Study protocol for a randomized controlled trial

Background Arm-crank exercise training (ACT) is an alternative exercise strategy for patients with symptomatic peripheral artery disease (PAD) due to the attenuation of pain symptoms during the exercise, as well as the benefits to functional capacity. Purpose The aim of this study is to describe the study protocol to analyze the effects of ACT exercise on cardiovascular function, functional capacity, cognition and quality of life in patients with symptomatic PAD. Methods This is a three-armed randomized, prospective, single-blind data collection, single-center, controlled study enrolling 45 patients with symptomatic PAD who will be randomized into 3 intervention groups: walking training (WT), ACT and control group. The WT and ACT will perform 2 sessions/week, 15 to 10 sets of 2 to 5 minutes at values of 13 to 15 on the Borg scale. Before and after 12 weeks of intervention, cardiovascular function (ambulatory blood pressure, office blood pressure, central blood pressure, heart rate variability, arterial stiffness and vascular function), functional capacity (six-minute walk test, 2 minute step test, handgrip test, Walking impairment questionnaire, Walking estimated limitation calculated by history, Baltimore activity scale for intermittent claudication, and short physical performance battery), cognition (executive function and memory), and quality of life (vascular quality of life questionnaire and World Health Organization Quality of Life) will be assessed. Results This is the first trial to evaluate the effects of ACT on regulatory mechanisms of the cardiovascular system in PAD patients. If the results are as expected, they will provide evidence the ability of ACT to promote cardiovascular benefits in the symptomatic PAD population.