Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nove de Julho
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change from baseline in vascular function post-exercise in the brachial and femoral arteries.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The outcomes assessor is blind for the condition performed by the patients.
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Exercise (Behavioral)
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.
Intervention: Exercise (Behavioral)
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.
Intervention: Exercise (Behavioral)
Outcomes
Primary Outcomes
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
- Change from baseline in cerebral blood velocity post-exercise.(Change from baseline at 35 minutes after the beginning of the exercise.)
- Change from baseline in blood pressure post-exercise.(Change from baseline at post-intervention, after 10 minutes.)
- Change from baseline in heart rate variability post-exercise.(Change from baseline at post-intervention, after 30 minutes.)
Investigators
Marilia de Almeida Correia
PhD
University of Nove de Julho