Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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The aim of the study will be to evaluate shear stress and blood flow parameters in lower limb arteries during arm cycle ergometer exercise in participants with peripheral artery disease. Twenty patients participants with peripheral artery disease and claudication symptoms will be recruited. Participants will perform 3 experimental sessions in random order. Iarm-cranking (15 sets of two minutes exercise), warm water foot immersion, and control. During the interventions, blood pressure and heart rate will be assessed every 6 minutes. Measurements of arterial diameter, blood flow, anterograde and retrograde shear stress of the femoral artery will be evaluated using a two-dimensional ultrasound device with spectral Doppler.

Official Title
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Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Arm-cranking exercise
* Other: Heating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of peripheral artery disease or ankle-brachial index less than 0.90 in one or both limbs do not present peripheral neuropathy; be able to exercise after medical approval aged 50 or over. Exclusion Criteria: Medication change during the study Health problems that contraindicates the practice of physical exercise.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm-cranking exercise<br>Patients will be perform arm-cranking exercise. The exercise will be performed in 15 sets of 2 min of exercise at a moderate intensity (13-15 in Borg scale) | Other: Arm-cranking exercise<br>* Arm-cranking exercise<br>* Other names: Exercise;|
| Active Comparator: Heating<br>Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees) | Other: Heating<br>* Immersion of the foot in warm water<br>|
| No Intervention: Control<br>Patients will remain seated for 60 min | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral artery diameter [mm] | Measurements will be obtained through duplex ultrasound in accordance with global recommendations. | Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention | 
| Femoral artery shear rate [sec.-1] | Measurements will be obtained through duplex ultrasound in accordance with global recommendations. | Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention | 
| Femoral artery Blood flow [mL/min] | Measurements will be obtained through duplex ultrasound in accordance with global recommendations. | Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial systolic and diastolic blood pressure [mmHg] | Systolic and diastolic blood pressures will be assessment in the arms with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan) | Before the intervention and at 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29 minutes into the intervention | 
| Heart rate [bpm] | Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland) | Before and up to 30 minutes into the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, arm-cranking, vascular function