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

NCT ID: NCT06068504

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Arm-cranking exercise

Intervention Type OTHER

Arm-cranking exercise

Heating

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

Group Type ACTIVE_COMPARATOR

Heating

Intervention Type OTHER

Immersion of the foot in warm water

Control

Patients will remain seated for 60 min

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arm-cranking exercise

Arm-cranking exercise

Intervention Type OTHER

Heating

Immersion of the foot in warm water

Intervention Type OTHER

Other Intervention Names

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Arm exercise Exercise

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Raphael Mendes Ritti Dias

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raphael Dias

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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University Nove de Julho

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Heating_PAD

Identifier Type: -

Identifier Source: org_study_id