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

Primary Purpose

Peripheral Arterial Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Arm-cranking exercise
Heating
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring exercise, arm-cranking, vascular function

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Arm-cranking exercise

Heating

Control

Arm Description

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)

Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)

Patients will remain seated for 60 min

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2023
Last Updated
September 28, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT06068504
Brief Title
Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease
Official Title
Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
exercise, arm-cranking, vascular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm-cranking exercise
Arm Type
Experimental
Arm Description
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)
Arm Title
Heating
Arm Type
Active Comparator
Arm Description
Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will remain seated for 60 min
Intervention Type
Other
Intervention Name(s)
Arm-cranking exercise
Other Intervention Name(s)
Arm exercise, Exercise
Intervention Description
Arm-cranking exercise
Intervention Type
Other
Intervention Name(s)
Heating
Intervention Description
Immersion of the foot in warm water
Primary Outcome Measure Information:
Title
Femoral artery diameter [mm]
Description
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
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
Title
Femoral artery shear rate [sec.-1]
Description
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
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
Title
Femoral artery Blood flow [mL/min]
Description
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
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
Secondary Outcome Measure Information:
Title
Brachial systolic and diastolic blood pressure [mmHg]
Description
Systolic and diastolic blood pressures will be assessment in the arms with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan)
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
Title
Heart rate [bpm]
Description
Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland)
Time Frame
Before and up to 30 minutes into the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Dias
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
One year after the study completion
IPD Sharing Access Criteria
Upon request

Learn more about this trial

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

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