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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Peripheral Arterial Disease; Intermittent Claudication; Blood Pressure; Endothelial Dysfunction
• Intervention / Treatment: Behavioral: 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01525-000
    • Nove de Julho University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking Condition; 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.	Behavioral: Exercise; Three conditions will be tested: Walking, arm-cranking and control condition.
Active Comparator: Arm-Cranking Condition; 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.	Behavioral: Exercise; Three conditions will be tested: Walking, arm-cranking and control condition.
Sham Comparator: Control Condition; 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.	Behavioral: Exercise; Three conditions will be tested: Walking, arm-cranking and control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in vascular function post-exercise in the brachial and femoral arteries.	Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.	Change from baseline at post-intervention, after 20 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood pressure post-exercise.	Blood pressure will be measured by an automatic monitor.	Change from baseline at post-intervention, after 10 minutes.
Change from baseline in heart rate variability post-exercise.	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.	Change from baseline at post-intervention, after 30 minutes.
Change from baseline in cerebral blood velocity post-exercise.	Cerebral blood velocity will be measured by a transcranial doppler ultrasound.	Change from baseline at 35 minutes after the beginning of the exercise.

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Marilia Correia, PhD, Nove de Julho University; Study Chair: Raphael Ritti-Dias, PhD, Nove de Julho University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: AcuteEBPAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data is planned to be made available after the completion of the study, if required.
• IPD Sharing Time Frame: Six months after the completion of the study.
• IPD Sharing Access Criteria: The data will be shared with certified researchers in the field.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No