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NCT Number: NCT06828172

Local or Systemic Effects: Mechanisms Related to Arm Crank Exercise - Comparison Between Individuals With and Without PAD

INTRODUCTION: Exercise with an arm ergometer (EB) overcomes the main barrier to physical exercise in patients with Peripheral Artery Disease (PAD), leg pain during walking. Due to its aerobic nature, this type of exercise can cause systemic changes in the regulatory mechanisms of vasodilation. In other words, it provides vascular benefits in the most affected arterial beds in the PAD population. OBJECTIVE: To analyze local and systemic vascular responses, as well as cell signaling pathways after an EB exercise session in patients with PAD and their peers without PAD. METHODS: 24 patients with PAD and 24 individuals without PAD will be recruited, matched by sex and age. Participants will undergo two experimental sessions in approved order (EB and control). The EB session will consist of 15 cycles of 2 min of exercise with an intensity equivalent to 13-15 on the Borg scale of perceived exertion. Before and after the experimental sessions, the vascular function of the brachial and femoral arteries, blood indicators of vasodilation and calf muscle oxygenation will be evaluated. To analyze the acute effect between groups on cardiovascular parameters, a three-way analysis of variance will be performed, taking as factors disease (presence vs. absence), session (EB vs. Control) and time (pre vs. post). In all analyses, when a significant effect is selected, the Bonferroni or Newman-Keuls post-hoc test will be used. For all analyses, a value of P<0.05 will be considered significant.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Intermittent Claudication Motor Activity Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Nove de Julho

São Paulo, 01525-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • If female, must be postmenopausal without hormone replacement therapy;
  • Non-smokers;
  • With a body mass index (BMI) not exceeding 30 kg/m²;
  • With calf skinfold thickness below 20 mm, due to the interference of adiposity in the penetration of light from the NIRS probe, and oxygen saturation in the finger >95% to ensure that impaired pulmonary gas exchange does not affect oxygen saturation measurements in the calf;
  • Not using classic antioxidants or vitamin supplements; and
  • Physically capable of performing an exercise session.
  • For the group of participants with PAD, in addition to the criteria mentioned above, they must have a confirmed diagnosis of the disease, characterized by an ankle-brachial index (ABI) lower than 0.90 in one or both legs, exhibit symptoms of claudication during walking, and be physically capable of performing an exercise session to participate in the project.

Exclusion criteria

  • Only participants who discontinue their participation in the study protocol will be excluded from the sample

Treatment and study plan

Exercise

Behavioral

Two conditions will be tested: Arm-cranking and control condition.

Primary outcomes

  1. Calf Muscle Oxygen Saturation (%)

    Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.

    The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.

Secondary outcomes

  1. Change from baseline in vascular function post-exercise in the brachial and femoral arteries (%).

    Time frame: Before and after 40 minutes of exercise.

    Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.

  2. Oxyhemoglobin (micromol)

    Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.

    The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.

  3. Deoxyhemoglobin (micromol)

    Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.

    The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.

  4. Total hemoglobin (micromol)

    Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.

    The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.

  5. Nitric oxide production markers (micromol)

    Time frame: Before and after 5 minutes of exercise.

    Before and after the sessions, a venous blood sample (10 mL) will be collected in tubes containing Ethylenediaminetetraacetic Acid (EDTA). Plasma will be immediately obtained after refrigerated centrifugation and used for the determination of thiobarbituric acid reactive substances (TBARS), nitrite, and nitrate (Griess test, Sigma Aldrich), as well as for biochemical analyses of lipids (cholesterol, triglycerides, High-Density Lipoprotein (HDL) cholesterol, and Low-Density Lipoprotein (LDL) cholesterol calculation) and glucose levels. Glycated hemoglobin will be determined in whole blood by high-performance liquid chromatography. Cultured human umbilical vein endothelial cells (HUVEC) will be incubated with 0.2% plasma obtained from all individuals for different time intervals. Indicators of nitric oxide production will be determined in the cells (cGMP concentration and endothelial nitric oxide synthase [eNOS] expression) and in the culture medium (nitrite/nitrate concentration).

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • University of Sao Paulo

Registry information

Official study title

Local or Systemic Vascular Effects: Mechanisms Related to Arm Crank Exercise - Comparison Between Individuals With and Without PAD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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