Effects of Aerobic Exercise on Arteriovenous Fistula

NCT ID: NCT04015674

Last Updated: 2019-07-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-02-01

Brief Summary

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Arteriovenous fistula (AVF) is considered the gold standard for safe and effective vascular access during hemodialytic treatment. It is known that systemic aerobic exercise is capable of promoting peripheral vasodilation, however, its effects on AVF are unknown. For this reason, we will evaluate the effects of aerobic exercise on a stationary bicycle over the AVF caliber.

Detailed Description

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Hemodialysis is a method responsible for filtering blood and helping to control excess blood fluid and impurities in patients with end-stage chronic kidney disease. The vascular accesses commonly used in this procedure is atribute catheter, which is placed in a large caliber vein, usually jugular or femoral vein, and arteriovenous fistula (AVF). In order to use the AVF in the hemodialysis procedure, a maturation process of the AVF is necessary, characterized by the increase of its caliber, which is accelerated by force exercises located in the AVF region, whose purpose is to promote the vasodilation of the AVF. Systemically performed aerobic exercises are also capable of promoting peripheral vasodilation and their effects on AVF are still unknown. Therefore, this study proposes to evaluate the behavior of the AVF through ultrasound before, during and after performing aerobic exercise on a stationary bicycle. For this, all patient will sign the informed consent form, respond to the International Physical Activity Questionnaire (IPAQ) and questionnaire Kidney Disease Quality of Life (KDQOL-SFTM), and use a pedometer for 7 days to measure the number of steps per day to characterize the sample. Patients will remain in supine position for 5 minutes to measure their vascular caliber of the AVF by echography. After, will be instructed to perform 30 minutes on stationary bike (Model Monark). The AVF vascular caliber will be measured during aerobic exercise. Because it is a cross-over trial, participants will perform the other arm after 7 days.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise group

Patients will remain in supine position for 5 minutes to measure their vascular caliber of the AVF by echography. After, will be instructed to perform 30 minutes on stationary bicycle (Model Monark). The AVF vascular caliber will be measured during aerobic exercise. Because it is a cross-over trial, participants will perform the other arm after 7 days.

Group Type EXPERIMENTAL

Exercise group

Intervention Type OTHER

Aerobic exercise on a stationary bicycle

Control group

Intervention Type OTHER

In a rest

Control group

The patients will perform 30 minutes of rest in a chair and the measurements will be performed in the same moments established by the exercise group. Because it is a cross-over trial, participants will perform the other arm after 7 days.

Group Type ACTIVE_COMPARATOR

Exercise group

Intervention Type OTHER

Aerobic exercise on a stationary bicycle

Control group

Intervention Type OTHER

In a rest

Interventions

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Exercise group

Aerobic exercise on a stationary bicycle

Intervention Type OTHER

Control group

In a rest

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who use AVF hemodialysis for at least 1 month.
* Patients on hemodialysis 3 times a week at the HCPA Nephrology Service.
* Age equal to or greater than 18 years.
* Physical conditions to perform exercises proposed in this study.
* Stability of chronic kidney disease for at least 30 days, defined by absence of hospitalization.

Exclusion Criteria

* Acute myocardial infarction in the last 3 months.
* Acute infectious or inflammatory process.
* Decompensated coronary artery disease.
* Symptomatic peripheral arterial disease.
* Arteriovenous fistula in lower limbs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Rovedder, PhD

Role: STUDY_DIRECTOR

UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grade Do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Paula Rovedder, PhD

Role: CONTACT

555133085885

Francini Porcher Andrade

Role: CONTACT

555133598121

Other Identifiers

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02867318.9.0000.5327

Identifier Type: -

Identifier Source: org_study_id

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