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

Primary Purpose

Intermittent Claudication, Cardiovascular Diseases, Blood Pressure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nove de Julho University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Walking Condition

Arm-Cranking Condition

Control Condition

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in blood pressure post-exercise.
Blood pressure will be measured by an automatic monitor.
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 in cerebral blood velocity post-exercise.
Cerebral blood velocity will be measured by a transcranial doppler ultrasound.

Full Information

First Posted
October 20, 2022
Last Updated
May 8, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05611021
Brief Title
Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease
Official Title
Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Cardiovascular Diseases, Blood Pressure, Endothelial Dysfunction, Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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 the Borg's subjective perceived exertion scale.
Masking
InvestigatorOutcomes Assessor
Masking Description
The outcomes assessor is blind for the condition performed by the patients.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking Condition
Arm Type
Experimental
Arm Description
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 Title
Arm-Cranking Condition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Condition
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Three conditions will be tested: Walking, arm-cranking and control condition.
Primary Outcome Measure Information:
Title
Change from baseline in vascular function post-exercise in the brachial and femoral arteries.
Description
Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.
Time Frame
Change from baseline at post-intervention, after 20 minutes.
Secondary Outcome Measure Information:
Title
Change from baseline in blood pressure post-exercise.
Description
Blood pressure will be measured by an automatic monitor.
Time Frame
Change from baseline at post-intervention, after 10 minutes.
Title
Change from baseline in heart rate variability post-exercise.
Description
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.
Time Frame
Change from baseline at post-intervention, after 30 minutes.
Title
Change from baseline in cerebral blood velocity post-exercise.
Description
Cerebral blood velocity will be measured by a transcranial doppler ultrasound.
Time Frame
Change from baseline at 35 minutes after the beginning of the exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilia Correia, PhD
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raphael Ritti-Dias, PhD
Organizational Affiliation
Nove de Julho University
Official's Role
Study Chair
Facility Information:
Facility Name
Nove de Julho University
City
São Paulo
ZIP/Postal Code
01525-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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