NCT06068504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

September 22, 2023

Last Update Submit

February 11, 2026

Conditions

Peripheral Arterial Disease

Keywords

exercisearm-crankingvascular function

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • 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

  • Heart rate [bpm]

    Before and up to 30 minutes into the intervention

Study Arms (3)

Arm-cranking exercise

EXPERIMENTAL

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

Heating

ACTIVE COMPARATOR

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

Other: Heating

Control

NO INTERVENTION

Patients will remain seated for 60 min

Interventions

Arm-cranking exerciseOTHER

Arm-cranking exercise

Also known as: Arm exercise, Exercise
Arm-cranking exercise
HeatingOTHER

Immersion of the foot in warm water

Heating

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Medication change during the study
  • Health problems that contraindicates the practice of physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Nove de Julho

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseMotor Activity

Interventions

Exercise TestExerciseHeating

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEnvironment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Raphael Dias

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 5, 2023

Study Start

November 1, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
One year after the study completion
Access Criteria
Upon request

Locations

BR(1)