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Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

Primary Purpose

Arteriovenous Fistula

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hand Exercise
Sponsored by
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring Arteriovenous Fistula, Pre-operative Exercise, Fistula Maturation

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Chronic Kidney failure patients with eGFR less than 20mls/min
  2. Chosen Hemodailysis as their modality of renal replacement therapy

Exclusion Criteria:

  1. Potential fistula vein diameter less than 3mm (with application of tornique) on initial vein mapping
  2. Known left ventricular ejection fraction of less than 20% on Echocardiogram
  3. Previous stroke effecting the AV fistula arm
  4. Calcified brachial or radial arteries and/or duplex evidence of stenosis of >50%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Arm

    Exercise Arm

    Arm Description

    No specific exercise regime for the control group. Usual hospital SOP will be adhered to

    The exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of 6 weeks. This will be performed at least 6 weeks prior to the creation of the AV fistula

    Outcomes

    Primary Outcome Measures

    Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
    AV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared

    Secondary Outcome Measures

    Suitability of cannulation of AV fistula
    Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation
    Secondary fistula failure
    Fistula outcomes will be assessed to review the need for angiographic procedures for AVF maturation and also look at secondary fistula failure

    Full Information

    First Posted
    April 28, 2017
    Last Updated
    April 28, 2017
    Sponsor
    Changi General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03137680
    Brief Title
    Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration
    Official Title
    Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2017 (Anticipated)
    Primary Completion Date
    December 15, 2018 (Anticipated)
    Study Completion Date
    March 20, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Changi General Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    To investigate the effect of pre-operative exercise on Hemodynamics in the fistula artery and vein, pre and post AV fistula formation Suitability of cannulation of AV fistula at 8weeks
    Detailed Description
    Aim: To investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, pre and post AV fistula formation as well as the suitability of cannulation of AV fistula at 8weeks post sugery Methodology: This is a randomised control study with 20 patients each in the exercise arm and the control arm. The subjects will be randomised 1:1 into one of the two groups. Chronic Kidney failure patients with eGFR less than 20mls/min and have chosen Haemodialysis as their modality of renal replacement therapy will be included the study. All the subjects will have an ultrasound doppler vein mapping done prior to entering the study. The exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks. All patients will have a follow up ultrasound doppler of the AV fistula at 8 weeks and 16 weeks post-surgery, looking at the AV fistula vein diameter, arterial diameter and blood flow rate. All the subjects will also be seen by a single vascular surgeon following the scan, to assess the suitability for AVF cannulation. Significance of the proposed study and benefits: A well functioning arterio-venous fistula is the gold standard vascular access for Hemodialysis patients due to its low rates of complications. The primary failure rate of the AVFs remain high at around 20 -25%, contributed by several factors including the diameter of the vessels. If pre-operative exercise improves the hemodynamics of the AV fistula and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AV fistulas.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arteriovenous Fistula
    Keywords
    Arteriovenous Fistula, Pre-operative Exercise, Fistula Maturation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Care Provider
    Masking Description
    Care Provider i.e., vascular surgeon are blinded to subject randomisation
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    No specific exercise regime for the control group. Usual hospital SOP will be adhered to
    Arm Title
    Exercise Arm
    Arm Type
    Experimental
    Arm Description
    The exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of 6 weeks. This will be performed at least 6 weeks prior to the creation of the AV fistula
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hand Exercise
    Intervention Description
    Exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks.
    Primary Outcome Measure Information:
    Title
    Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
    Description
    AV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared
    Time Frame
    22 weeks
    Secondary Outcome Measure Information:
    Title
    Suitability of cannulation of AV fistula
    Description
    Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation
    Time Frame
    8 Weeks
    Title
    Secondary fistula failure
    Description
    Fistula outcomes will be assessed to review the need for angiographic procedures for AVF maturation and also look at secondary fistula failure
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic Kidney failure patients with eGFR less than 20mls/min Chosen Hemodailysis as their modality of renal replacement therapy Exclusion Criteria: Potential fistula vein diameter less than 3mm (with application of tornique) on initial vein mapping Known left ventricular ejection fraction of less than 20% on Echocardiogram Previous stroke effecting the AV fistula arm Calcified brachial or radial arteries and/or duplex evidence of stenosis of >50%
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sreekanth Koduri
    Phone
    85680120
    Email
    Sreekanth_Koduri@cgh.com.sg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    36184076
    Citation
    Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.
    Results Reference
    derived

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    Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

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