NCT03837639

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

Status unknown NA Last updated 7 December 2021

What this trial tests

NA trial testing Arm ergometer in Peripheral Arterial Disease in 45 participants. Status unknown.

Timeline

10 June 2019

Primary endpoint
10 December 2022

10 December 2023

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	10 June 2019
Primary completion	10 December 2022
Estimated completion	10 December 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Arm ergometer
• Treadmill ergometer
• Control group — full drug profile →

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Intermittent Claudication — all drugs for Intermittent Claudication →
• Hypertension — all drugs for Hypertension →

Sponsor

Hospital Israelita Albert Einstein

Who can join

Adults 45 to 85, any sex, with Peripheral Arterial Disease or Intermittent Claudication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modes of exercise training for intermittent claudication.
   Jansen SC, Abaraogu UO, Lauret GJ, Fakhry F, et al · · 2020 · cited 17× · PMID 32829481 · DOI 10.1002/14651858.cd009638.pub3
2. 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.
   Kanegusuku H, Correia MA, Longano P, Ritti-Dias RM, et al · · 2022 · PMID 35511887 · DOI 10.1371/journal.pone.0267849