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

University of Nove de Julho

Status: Invitation-only

Conditions: Peripheral Arterial Disease

Treatments: Other: Heating; Other: Arm-cranking exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06068504

Heating_PAD

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Arm-cranking exercise

Experimental group

Description:

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)

Treatment:

Other: Arm-cranking exercise

Heating

Active Comparator group

Description:

Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)

Treatment:

Other: Heating

Control

No Intervention group

Description:

Patients will remain seated for 60 min