Clinical trial NCT05611021: Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease
Official title: Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Cardiovascular Diseases
Blood Pressure
Endothelial Dysfunction
Peripheral Arterial Disease
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on the Borg's subjective perceived exertion scale.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.

Detailed description: Twenty patients with peripheral arterial disease and claudication symptoms will be recruited. The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on Borg's Subjective Perceived Exertion Scale. During the experimental conditions (walking, arm-cranking and control) blood pressure, heart rate and cerebral blood velocity will be evaluated, along with perceived exertion and affective responses. Before and after experimental conditions, vascular function, blood pressure, heart rate variability, cerebral blood velocity, subjective perceived exertion and affective responses will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Peripheral arterial disease diagnosis;
* Age ≥ 40 years old;
* If a woman, be in menopause without the use of hormone replacement therapy;
* Do not be an active smoker;
* Be apt to perform exercise.

Exclusion Criteria:

* Any change in medication;
* Any health impairment that contraindicates the practice of physical exercise.

Primary outcomes:
measure: Change from baseline in vascular function post-exercise in the brachial and femoral arteries.
timeFrame: Change from baseline at post-intervention, after 20 minutes.
Secondary outcomes:
measure: Change from baseline in blood pressure post-exercise.
timeFrame: Change from baseline at post-intervention, after 10 minutes.
measure: Change from baseline in heart rate variability post-exercise.
timeFrame: Change from baseline at post-intervention, after 30 minutes.
measure: Change from baseline in cerebral blood velocity post-exercise.
timeFrame: Change from baseline at 35 minutes after the beginning of the exercise.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: Nove de Julho University
name: Marilia Correia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nove de Julho University
name: Raphael Ritti-Dias, PhD
role: STUDY_CHAIR
References: