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Completed

NCT Number: NCT05611021

Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease

The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nove de Julho University

São Paulo, 01525-000, Brazil

About this study

Twenty patients with peripheral arterial disease and claudication symptoms will be recruited. The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on Borg's Subjective Perceived Exertion Scale. During the experimental conditions (walking, arm-cranking and control) blood pressure, heart rate and cerebral blood velocity will be evaluated, along with perceived exertion and affective responses. Before and after experimental conditions, vascular function, blood pressure, heart rate variability, cerebral blood velocity, subjective perceived exertion and affective responses will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peripheral arterial disease diagnosis;
  • Age ≥ 40 years old;
  • If a woman, be in menopause without the use of hormone replacement therapy;
  • Do not be an active smoker;
  • Be apt to perform exercise.

Exclusion criteria

  • Any change in medication;
  • Any health impairment that contraindicates the practice of physical exercise.

Treatment and study plan

Exercise

Behavioral

Three conditions will be tested: Walking, arm-cranking and control condition.

Primary outcomes

  1. Change from baseline in vascular function post-exercise in the brachial and femoral arteries.

    Time frame: Change from baseline at post-intervention, after 20 minutes.

    Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.

Secondary outcomes

  1. Change from baseline in blood pressure post-exercise.

    Time frame: Change from baseline at post-intervention, after 10 minutes.

    Blood pressure will be measured by an automatic monitor.

  2. Change from baseline in heart rate variability post-exercise.

    Time frame: Change from baseline at post-intervention, after 30 minutes.

    Autonomic modulation of the cardiovascular system will be measured by the heart rate variability (HRV) technique, by a heart rate monitor valid for this function.

  3. Change from baseline in cerebral blood velocity post-exercise.

    Time frame: Change from baseline at 35 minutes after the beginning of the exercise.

    Cerebral blood velocity will be measured by a transcranial doppler ultrasound.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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