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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intermittent Claudication, Cardiovascular Diseases, Blood Pressure, Endothelial Dysfunction, Peripheral Arterial Disease

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Condition<br>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<br>* Three conditions will be tested: Walking, arm-cranking and control condition.<br>|
| Active Comparator: Arm-Cranking Condition<br>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<br>* Three conditions will be tested: Walking, arm-cranking and control condition.<br>|
| Sham Comparator: Control Condition<br>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<br>* Three conditions will be tested: Walking, arm-cranking and control condition.<br>|

What is the study measuring?
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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. |