Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease

Hypertension Clinical Trial

Official title: Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE) training on cardiovascular function in PAD patients, and compare it with treadmill exercise (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will be allocated randomly in three experimental groups: ACE training, TE and control group. ACE and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a week, however only to perform diverse activities and group living, without any type of exercise involved. All groups will be encouraged to increase their levels of activity, as they are usually guided in medical consultations. Before and after 12 weeks of intervention, cardiovascular function, functional capacity, cognition, and quality of life will be assessed.

Clinical Trial Description

Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic peripheral artery disease (PAD) due the benefits on functional capacity and quality of life, besides provoking less or no pain symptoms during the execution. This study sought to describe the protocol of a study that will analyse the effect of ACT exercise on walking capacity, cardiovascular function, cognition and quality of life in patients with symptomatic PAD.

This is a three-armed randomized, prospective, single-blind data collection, single-center, controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3 intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes, Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention, cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood pressure, heart rate variability, arterial stiffness, vascular function), functional capacity (six-minute walking test, 2 minute step test [2 MST], Walking impairment questionnaire [WIQ], Walking estimated limitation calculated by history [WELCH], Baltimore activity scale for intermittent claudication, handgrip test and short physical performance battery [SPPB]), cognition (executive function and memory) and quality of life (short version of world health organization quality of life and vascular quality of life questionnaire [VASCUQOL-6]) will be assessed.

This is the first trial to evaluate the effects of ACT on regulatory mechanisms of cardiovascular system in PAD patients. If the results are as expected, they will provide evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population. ;

Related Conditions & MeSH terms

• Hypertension
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

• NCT number: NCT03837639
• Study type: Interventional
• Source: Hospital Israelita Albert Einstein
• Contact: Raphael M Ritti-Dias, PhD
• Phone: +551999406878
• Email: raphaelritti@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Completion date: December 10, 2023