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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Arm-cranking exercise; Other: Heating

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • University Nove de Julho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Arm-cranking exercise; Arm-cranking exercise; Other Names: Exercise; Arm exercise
Active Comparator: Heating; Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)	Other: Heating; Immersion of the foot in warm water
No Intervention: Control; Patients will remain seated for 60 min

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Raphael Dias, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise; vascular function; arm-cranking
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Behavior; Peripheral Arterial Disease; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Environment and Public Health; Environment; Environment, Controlled; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Exercise; Exercise Test; Heating
• Other Study ID Numbers: Heating_PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: One year after the study completion
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No