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

NCT05611021 | Completed

• 1 other identifier: AcuteEBPAD
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication; Cardiovascular Diseases; Blood Pressure; Endothelial Dysfunction; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in blood pressure post-exercise.

  Change from baseline at post-intervention, after 10 minutes.

• Change from baseline in heart rate variability post-exercise.

  Change from baseline at post-intervention, after 30 minutes.

• Change from baseline in cerebral blood velocity post-exercise.

  Change from baseline at 35 minutes after the beginning of the exercise.

Study Arms (3)

Walking Condition

EXPERIMENTAL

In the walking condition, the patients will perform fifteen bouts of two minutes of treadmill walking 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.

Behavioral: Exercise

Arm-Cranking Condition

ACTIVE COMPARATOR

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.

Behavioral: Exercise

Control Condition

SHAM COMPARATOR

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Arm-Cranking Condition; Control Condition; Walking Condition

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01525-000, Brazil

Location

MeSH Terms

Conditions

Intermittent Claudication; Cardiovascular Diseases; Peripheral Arterial Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marilia Correia, PhD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

• Raphael Ritti-Dias, PhD

  Nove de Julho University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is blind for the condition performed by the patients.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 9, 2022
• Study Start: June 8, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Six months after the completion of the study.
• Access Criteria: The data will be shared with certified researchers in the field.

Locations

BR (1)