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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06068504

Enrollment

Registered

2023-10-05

Start date

2023-11-01

Completion date

2025-11-30

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

exercise, arm-cranking, vascular function

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.

Interventions

OTHERArm-cranking exercise

Arm-cranking exercise

OTHERHeating

Immersion of the foot in warm water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 100 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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)

Countries

Brazil

Contacts

PRINCIPAL_INVESTIGATORRaphael Dias

University of Nove de Julho

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026