NCT04015674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 9, 2019

Last Update Submit

July 9, 2019

Conditions

Chronic Kidney Diseases

Keywords

ExerciseVasodilation

Outcome Measures

Primary Outcomes (1)

  • Arteriovenous fistula caliber

    The arteriovenous fistula caliber will be measured using ultrasound.

    30 minutes

Secondary Outcomes (2)

  • Arterial pressure of carbon dioxide (PaCO2)

    after 30 minutes of exercise or rest

  • Arterial oxygen pressure (PaO2)

    after 30 minutes of exercise or rest

Other Outcomes (7)

  • Creatinine

    after 30 minutes of exercise or rest

  • Urea

    after 30 minutes of exercise or rest

  • phosphorus

    after 30 minutes of exercise or rest

  • +4 more other outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

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 groupOther: Control group

Control group

ACTIVE COMPARATOR

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 groupOther: Control group

Interventions

Exercise groupOTHER

Aerobic exercise on a stationary bicycle

Control groupExercise group
Control groupOTHER

In a rest

Control groupExercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grade Do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor ActivityAneurysm

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Paula Rovedder, PhD

    UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

    STUDY DIRECTOR

Central Study Contacts

Paula Rovedder, PhD

CONTACT

555133085885larove_@hotmail.com

Francini Porcher Andrade

CONTACT

555133598121fran_porcher@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 11, 2019

Study Start

March 25, 2019

Primary Completion

January 2, 2020

Study Completion

February 1, 2020

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)