Clinical trial NCT06828172: Local or Systemic Effects: Mechanisms Related to Arm Crank Exercise - Comparison Between Individuals With and Without PAD
Official title: Local or Systemic Vascular Effects: Mechanisms Related to Arm Crank Exercise - Comparison Between Individuals With and Without PAD
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Intermittent claudication
Exercise
Vascular function
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2025-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Calf Muscle Oxygen Saturation (%)
timeFrame: 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.
Secondary outcomes:
measure: Change from baseline in vascular function post-exercise in the brachial and femoral arteries (%).
timeFrame: Before and after 40 minutes of exercise.
measure: Oxyhemoglobin (micromol)
timeFrame: 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.
measure: Deoxyhemoglobin (micromol)
timeFrame: 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.
measure: Total hemoglobin (micromol)
timeFrame: 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.
measure: Nitric oxide production markers (micromol)
timeFrame: Before and after 5 minutes of exercise.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Marilia A Correia, PhD
role: PRINCIPAL_INVESTIGATOR
References: