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Trials / Enrolling By Invitation

Enrolling By InvitationNCT06828172

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

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

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
University of Nove de Julho · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

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

Interventions

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

Timeline

Start date
2025-03-24
Primary completion
2027-07-15
Completion
2027-07-15
First posted
2025-02-14
Last updated
2026-04-13

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT06828172. Inclusion in this directory is not an endorsement.