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

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Other: Arm-cranking exercise; Other: Heating

• Registration Number: NCT06068504
• Lead Sponsor: University of Nove de Julho

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm-cranking exercise	Arm-cranking exercise	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)
Heating	Heating	Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)

Primary Outcome Measures

Name	Time	Method
Femoral artery Blood flow [mL/min]	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	Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
Femoral artery diameter [mm]	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	Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
Femoral artery shear rate [sec.-1]	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	Measurements will be obtained through duplex ultrasound in accordance with global recommendations.

Secondary Outcome Measures

Name	Time	Method
Brachial systolic and diastolic blood pressure [mmHg]	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	Systolic and diastolic blood pressures will be assessment in the arms with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan)
Heart rate [bpm]	Before and up to 30 minutes into the intervention	Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland)

Trial Locations

Locations (1)

University Nove de Julho; 🇧🇷 São Paulo, Brazil