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Completed

NCT Number: NCT06068504

Shear Stress in the Arteries of the Lower Limbs During 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Motor Activity Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Nove de Julho

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arm-cranking exercise

Other

Arm-cranking exercise

Other names: Arm exercise, Exercise

Heating

Other

Immersion of the foot in warm water

Primary outcomes

  1. Femoral artery diameter [mm]

    Time frame: 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.

  2. Femoral artery shear rate [sec.-1]

    Time frame: 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.

  3. Femoral artery Blood flow [mL/min]

    Time frame: 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 outcomes

  1. Brachial systolic and diastolic blood pressure [mmHg]

    Time frame: 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)

  2. Heart rate [bpm]

    Time frame: Before and up to 30 minutes into the intervention

    Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland)

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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