Peripheral Arterial DiseaseNCT06068504
Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease
A study testing Arm-cranking exercise and Heating in people with Peripheral Arterial Disease, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Arm-cranking exercise and Heating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Medication change during the study
- Health problems that contraindicates the practice of physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Arm-cranking exercise, Heating
- Keywords
- exercise, arm-cranking, vascular function
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm-cranking exerciseOther
Also called Arm exercise, Exercise
Arm-cranking exercise
HeatingOther
Immersion of the foot in warm water
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Heating |
| Control | No intervention | Patients will remain seated for 60 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral artery diameter [mm]
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
Measured: 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.
Measured: 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.
Measured: 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]
Systolic and diastolic blood pressures will be assessment in the arms with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan)
Measured: 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]
Heart rate assessment with a heart rate monitor (Polar H10, Polar®, Finland)
Measured: Before and up to 30 minutes into the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael Dias, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068504
- Sponsor's protocol ID
- Heating_PAD
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06068504
- Acronym / sponsor ID
- Heating_PAD
- Conditions
- Peripheral Arterial Disease
- Keywords
- exercise, arm-cranking, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm-cranking exercise | Experimental | Other: Arm-cranking exercisePatients 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) |
| Heating | Active comparator | Other: HeatingPatients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees) |
| Control | No intervention | –Patients will remain seated for 60 min |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Medication change during the study
- Health problems that contraindicates the practice of physical exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm-cranking exerciseAlso: Arm exercise, ExerciseArm-cranking exercise | Other | Arm-cranking exercise |
| HeatingImmersion of the foot in warm water | Other | Heating |
Primary outcome
Femoral artery diameter [mm]
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
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
Femoral artery shear rate [sec.-1]
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
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
Femoral artery Blood flow [mL/min]
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
Measurements will be obtained through duplex ultrasound in accordance with global recommendations.
2 secondary outcomes
Brachial systolic and diastolic blood pressure [mmHg]
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
Heart rate [bpm]
Time frame: Before and up to 30 minutes into the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Dias principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm-cranking exercise and Heating in people with Peripheral Arterial Disease, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral artery diameter [mm] (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.