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

NCT ID: NCT05611021

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2024-12-20

Brief Summary

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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

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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.

Conditions

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Intermittent Claudication Cardiovascular Diseases Blood Pressure Endothelial Dysfunction Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The outcomes assessor is blind for the condition performed by the patients.

Study Groups

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Walking Condition

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Arm-Cranking Condition

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 ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Three conditions will be tested: Walking, 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

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

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Marilia de Almeida Correia

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marilia Correia, PhD

Role: PRINCIPAL_INVESTIGATOR

Nove de Julho University

Raphael Ritti-Dias, PhD

Role: STUDY_CHAIR

Nove de Julho University

Locations

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Nove de Julho University

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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AcuteEBPAD

Identifier Type: -

Identifier Source: org_study_id

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