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

Not Applicable

Completed

• Conditions: Endothelial Dysfunction; Intermittent Claudication; Blood Pressure; Cardiovascular Diseases; Peripheral Arterial Disease
• Interventions: Behavioral: Exercise

• Registration Number: NCT05611021
• Lead Sponsor: University of Nove de Julho

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-06-08
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-09
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Condition	Exercise	The control condition will consist of resting in the standing position for thirty minutes. The patients will be instructed to rest in the sitting position for two minutes at periods equivalent to the intervals from the exercise conditions, totalling sixty minutes of duration.
Walking Condition	Exercise	In the walking condition, the patients will perform fifteen bouts of two minutes of treadmill walking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration.
Arm-Cranking Condition	Exercise	In the arm-cranking condition, the patients will perform fifteen bouts of two minutes of arm-cranking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration.

Primary Outcome Measures

Name	Time	Method
Change from baseline in vascular function post-exercise in the brachial and femoral arteries.	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 Outcome Measures

Name	Time	Method
Change from baseline in cerebral blood velocity post-exercise.	Change from baseline at 35 minutes after the beginning of the exercise.	Cerebral blood velocity will be measured by a transcranial doppler ultrasound.
Change from baseline in blood pressure post-exercise.	Change from baseline at post-intervention, after 10 minutes.	Blood pressure will be measured by an automatic monitor.
Change from baseline in heart rate variability post-exercise.	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.

Trial Locations

Locations (1)

Nove de Julho University; 🇧🇷 São Paulo, Brazil