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Enrolling by invitation NCT06828172

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

No phase Interventional Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (5)
  • Change from baseline in vascular function post-exercise in the brachial and femoral arteries (%). [Time frame: Before and after 40 minutes of exercise.]
  • 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.]
  • 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.]
  • 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.]
  • Nitric oxide production markers (micromol) [Time frame: Before and after 5 minutes of exercise.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • University Nove de Julho — São Paulo

Identifiers

NCT: NCT06828172 · EB_PADvsHealth

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗