CClinicalTrials.gg
Status unknownNCT04015674Updated Jul 11, 2019

Effects of Aerobic Exercise on Arteriovenous Fistula

An interventional study of Exercise group and Control group in Chronic Kidney Diseases, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2019, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Kidney Diseases

Keywords

  • Exercise
  • Vasodilation
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 10 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • 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 · Other: Control group

  • 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 · Other: Control group

Interventions

  • OtherExercise group

    Aerobic exercise on a stationary bicycle

  • OtherControl group

    In a rest

06

What researchers measure

Primary outcomes

  1. Arteriovenous fistula caliber

    The arteriovenous fistula caliber will be measured using ultrasound.

    Time frame: 30 minutes

Secondary outcomes

  1. Arterial pressure of carbon dioxide (PaCO2)

    Gasometry

    Time frame: after 30 minutes of exercise or rest

  2. Arterial oxygen pressure (PaO2)

    Gasometry

    Time frame: after 30 minutes of exercise or rest

Other outcomes

  1. Creatinine

    Serum levels

    Time frame: after 30 minutes of exercise or rest

  2. Urea

    Serum levels

    Time frame: after 30 minutes of exercise or rest

  3. phosphorus

    Serum levels

    Time frame: after 30 minutes of exercise or rest

  4. potassium

    Serum levels

    Time frame: after 30 minutes of exercise or rest

  5. sodium

    Serum levels

    Time frame: after 30 minutes of exercise or rest

  6. calcium

    Serum levels

    Time frame: after 30 minutes of exercise or rest

  7. blood count

    Serum levels

    Time frame: after 30 minutes of exercise or rest

07

Study locations

1 of 1 sites recruiting
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grade Do Sul 90035903, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04015674
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Jul 11, 2019
Start date
Mar 25, 2019
Primary completion
Jan 2, 2020 (estimated)
Completion
Feb 1, 2020 (estimated)
Last update
Jul 11, 2019

Study contacts

Paula Rovedder, PhD
Contact
larove_@hotmail.com
555133085885
Francini Porcher Andrade
Contact
fran_porcher@hotmail.com
555133598121
Paula Rovedder, PhD
study director · UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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