Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease

Cardiovascular Diseases Clinical Trial

Official title:

Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05611021
• Other study ID #: AcuteEBPAD
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2024
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Endothelial Dysfunction
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Exercise
Three conditions will be tested: Walking, arm-cranking and control condition.

Locations

Country	Name	City	State
Brazil	Nove de Julho University	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in vascular function post-exercise in the brachial and femoral arteries.	Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.	Change from baseline at post-intervention, after 20 minutes.
Secondary	Change from baseline in blood pressure post-exercise.	Blood pressure will be measured by an automatic monitor.	Change from baseline at post-intervention, after 10 minutes.
Secondary	Change from baseline in heart rate variability post-exercise.	Autonomic modulation of the cardiovascular system will be measured by the heart rate variability (HRV) technique, by a heart rate monitor valid for this function.	Change from baseline at post-intervention, after 30 minutes.
Secondary	Change from baseline in cerebral blood velocity post-exercise.	Cerebral blood velocity will be measured by a transcranial doppler ultrasound.	Change from baseline at 35 minutes after the beginning of the exercise.