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

NCT ID: NCT06828172

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-24
• Study Completion Date: 2026-10-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm crank exercise

In the arm-cranking condition, the patients will perform fifteen bouts of two minutes of arm-cranking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Control Condition

The control condition will consist of resting in the standing position for thirty minutes. The patients will be instructed to rest in the sitting position for two minutes at periods equivalent to the intervals from the exercise conditions, totalling sixty minutes of duration.

Group Type: SHAM_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Marilia de Almeida Correia

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marilia A Correia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

University Nove de Julho

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EB_PADvsHealth

Identifier Type: -

Identifier Source: org_study_id