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出境医 / 临床实验 / Effects of Aerobic Exercise on Arteriovenous Fistula

Effects of Aerobic Exercise on Arteriovenous Fistula

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Other: Exercise group Other: Control group Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : January 2, 2020
Estimated Study Completion Date : February 1, 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Arteriovenous fistula caliber [ Time Frame: 30 minutes ]
    The arteriovenous fistula caliber will be measured using ultrasound.


Secondary Outcome Measures :
  1. Arterial pressure of carbon dioxide (PaCO2) [ Time Frame: after 30 minutes of exercise or rest ]
    Gasometry

  2. Arterial oxygen pressure (PaO2) [ Time Frame: after 30 minutes of exercise or rest ]
    Gasometry


Other Outcome Measures:
  1. Creatinine [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels

  2. Urea [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels

  3. phosphorus [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels

  4. potassium [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels

  5. sodium [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels

  6. calcium [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels

  7. blood count [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Paula Rovedder, PhD 555133085885 larove_@hotmail.com
Contact: Francini Porcher Andrade 555133598121 fran_porcher@hotmail.com

Locations
Layout table for location information
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grade Do Sul, Brazil, 90035903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
Study Director: Paula Rovedder, PhD UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		Arteriovenous fistula caliber [ Time Frame: 30 minutes ]
The arteriovenous fistula caliber will be measured using ultrasound.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Arterial pressure of carbon dioxide (PaCO2) [ Time Frame: after 30 minutes of exercise or rest ]
    Gasometry
  • Arterial oxygen pressure (PaO2) [ Time Frame: after 30 minutes of exercise or rest ]
    Gasometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2019)
  • Creatinine [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
  • Urea [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
  • phosphorus [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
  • potassium [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
  • sodium [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
  • calcium [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
  • blood count [ Time Frame: after 30 minutes of exercise or rest ]
    Serum levels
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Aerobic Exercise on Arteriovenous Fistula
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Chronic Kidney Diseases
Intervention  ICMJE
  • Other: Exercise group
    Aerobic exercise on a stationary bicycle
  • Other: Control group
    In a rest
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Other: Exercise group
    • Other: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paula Rovedder, PhD 555133085885 larove_@hotmail.com
Contact: Francini Porcher Andrade 555133598121 fran_porcher@hotmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015674
Other Study ID Numbers  ICMJE 02867318.9.0000.5327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paula Rovedder, PhD UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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