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Effects of Aerobic Exercise on Arteriovenous Fistula

Primary Purpose

Chronic Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise group
Control group
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Kidney Diseases focused on measuring Exercise, Vasodilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Arteriovenous fistula caliber
The arteriovenous fistula caliber will be measured using ultrasound.

Secondary Outcome Measures

Arterial pressure of carbon dioxide (PaCO2)
Gasometry
Arterial oxygen pressure (PaO2)
Gasometry

Full Information

First Posted
July 9, 2019
Last Updated
July 9, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04015674
Brief Title
Effects of Aerobic Exercise on Arteriovenous Fistula
Official Title
Effects of Aerobic Exercise on the Vascular Caliber of the Arteriovenous Fistula in Patients With Chronic Kidney Disease on Hemodialysis: a Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
January 2, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Exercise, Vasodilation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise group
Intervention Description
Aerobic exercise on a stationary bicycle
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
In a rest
Primary Outcome Measure Information:
Title
Arteriovenous fistula caliber
Description
The arteriovenous fistula caliber will be measured using ultrasound.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Arterial pressure of carbon dioxide (PaCO2)
Description
Gasometry
Time Frame
after 30 minutes of exercise or rest
Title
Arterial oxygen pressure (PaO2)
Description
Gasometry
Time Frame
after 30 minutes of exercise or rest
Other Pre-specified Outcome Measures:
Title
Creatinine
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest
Title
Urea
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest
Title
phosphorus
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest
Title
potassium
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest
Title
sodium
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest
Title
calcium
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest
Title
blood count
Description
Serum levels
Time Frame
after 30 minutes of exercise or rest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Rovedder, PhD
Phone
555133085885
Email
larove_@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Francini Porcher Andrade
Phone
555133598121
Email
fran_porcher@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Rovedder, PhD
Organizational Affiliation
UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grade Do Sul
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Aerobic Exercise on Arteriovenous Fistula

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