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