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

Sponsor
University of Nove de Julho (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06068504
Collaborator
(none)
20
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arm-cranking exercise
  • Other: Heating
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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:
  • Arm exercise
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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 Outcome Measures

    1. 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)

    2. Heart rate [bpm] [Before and up to 30 minutes into the intervention]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Nove de Julho São Paulo Brazil 01504-001

    Sponsors and Collaborators

    • University of Nove de Julho

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Raphael Mendes Ritti Dias, Principal Investigator, University of Nove de Julho
    ClinicalTrials.gov Identifier:
    NCT06068504
    Other Study ID Numbers:
    • Heating_PAD
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Raphael Mendes Ritti Dias, Principal Investigator, University of Nove de Julho
    exercise
    arm-cranking
    vascular function
    Additional relevant MeSH terms:
    Peripheral Arterial Disease
    Peripheral Vascular Diseases

    Study Results

    No Results Posted as of Oct 5, 2023