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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06068504
• Other study ID #: Heating_PAD
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Arm-cranking exercise
Arm-cranking exercise
• Heating
Immersion of the foot in warm water

Locations

Country	Name	City	State
Brazil	University Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Heart rate [bpm]	Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland)	Before and up to 30 minutes into the intervention