Effects of Aerobic Exercise on Arteriovenous Fistula

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Exercise group; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paula Rovedder, PhD; Phone Number: 555133085885; Email: larove_@hotmail.com
• Study Contact Backup: Name: Francini Porcher Andrade; Phone Number: 555133598121; Email: fran_porcher@hotmail.com

Study Locations

• Brazil
  • Rio Grade Do Sul
    • Porto Alegre, Rio Grade Do Sul, Brazil, 90035903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Exercise group; Aerobic exercise on a stationary bicycle; Other: Control group; In a rest
Active Comparator: 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.	Other: Exercise group; Aerobic exercise on a stationary bicycle; Other: Control group; In a rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arteriovenous fistula caliber	The arteriovenous fistula caliber will be measured using ultrasound.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial pressure of carbon dioxide (PaCO2)	Gasometry	after 30 minutes of exercise or rest
Arterial oxygen pressure (PaO2)	Gasometry	after 30 minutes of exercise or rest

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine	Serum levels	after 30 minutes of exercise or rest
Urea	Serum levels	after 30 minutes of exercise or rest
phosphorus	Serum levels	after 30 minutes of exercise or rest
potassium	Serum levels	after 30 minutes of exercise or rest
sodium	Serum levels	after 30 minutes of exercise or rest
calcium	Serum levels	after 30 minutes of exercise or rest
blood count	Serum levels	after 30 minutes of exercise or rest

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Paula Rovedder, PhD, UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Anticipated): January 2, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Vasodilation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 02867318.9.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No