Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
Primary Purpose
End Stage Renal Disease, Arteriovenous Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for End Stage Renal Disease focused on measuring Arteriovenous Fistula, AVF Maturation, Pre Operative exercise
Eligibility Criteria
Inclusion Criteria:
- Age >=21 to <= 90.
- Chronic Kidney Failure patients with Estimated Glomerular Filtration Rate (eGFR) less than 20mls/min.
- Haemodialysis is chosen as their modality of renal replacement therapy.
Exclusion Criteria:
- Potential fistula vein diameter <= 3mm (with application of tornique) on initial vein mapping.
- Known Left ventricular ejection fraction of less than 20% on Echo diagram.
- Previous stroke effecting the AVF arm.
- Calcified brachial or radial arteries and/or duplex evidence of stenosis of >= 50%
Sites / Locations
- Tang Tjun YipRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Exercise
No Exercise
Arm Description
Patient randomized are required to squeeze a soft ball 10 times for a set. They are required to perform 3 sets of 10 squeezes each at a 1 Minute interval. 3 sets of exercises to be performed twice in the Morning and Evening, for a total of 6 weeks.
Patient is not required to do any exercise.
Outcomes
Primary Outcome Measures
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
Measure with the use of an Ultrasound Doppler
Diameter of the Artery - Brachial & Radial
Measure with the use of an Ultrasound Doppler
Diameter of the Artery used for AVF
Measure with the use of an Ultrasound Doppler
Change of Blood Flow Rate in the Artery
Measure with the use of an Ultrasound Doppler
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis
Measure with the use of an Ultrasound Doppler
Diameter of the artery 2cm above anastomosis
Measure with the use of an Ultrasound Doppler
Suitability for Cannulation
Measure with the use of an Ultrasound Doppler
Secondary Outcome Measures
Full Information
NCT ID
NCT03886116
First Posted
March 14, 2019
Last Updated
September 23, 2021
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03886116
Brief Title
Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
Official Title
Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore 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
No
5. Study Description
Brief Summary
This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery.
This is a randomised control study with 20 patients each in the Control arm (Group A) or the Exercise arm (Group B). The subjects will be randomised into 1:1 into one of the two groups.
The patients will have an ultrasound doppler vein mapping done prior surgery and the necessary follow up visits.
Detailed Description
The incident and prevalent population on renal replacement therapy for End Stage Renal Disease (ESRD) is steadily increasing in Singapore as well as other countries worldwide. Around 85 - 90% of the prevalent dialysis population is on Hemodialysis and Arteriovenous Fistula (AVF).
AVF is considered the Gold standard for safe and effective vascular access for hemodialysis treatment due to its low rates of complication. However, Primary Failure rate of AVFs remain high at around 20 - 25% depending on the site of the surgery, contributed by several factors including the diameter of the artery and the vein used for AVF formation.
If Pre-operative exercise improves the hemodynamics of the AVF and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AVF.
Even though, there is sufficient evidence to support the beneficial role of the forearm exercises on fistula blood flow and maturation, there are no studies looking at the effects of Pre-Operative Exercise on AVF maturation. Our Study is aiming to fulfil this gap in knowledge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Arteriovenous Fistula
Keywords
Arteriovenous Fistula, AVF Maturation, Pre Operative exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Patient randomized are required to squeeze a soft ball 10 times for a set. They are required to perform 3 sets of 10 squeezes each at a 1 Minute interval.
3 sets of exercises to be performed twice in the Morning and Evening, for a total of 6 weeks.
Arm Title
No Exercise
Arm Type
No Intervention
Arm Description
Patient is not required to do any exercise.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.
Primary Outcome Measure Information:
Title
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
Description
Measure with the use of an Ultrasound Doppler
Time Frame
Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Title
Diameter of the Artery - Brachial & Radial
Description
Measure with the use of an Ultrasound Doppler
Time Frame
Baseline
Title
Diameter of the Artery used for AVF
Description
Measure with the use of an Ultrasound Doppler
Time Frame
1 Week Pre-Op
Title
Change of Blood Flow Rate in the Artery
Description
Measure with the use of an Ultrasound Doppler
Time Frame
Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Title
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis
Description
Measure with the use of an Ultrasound Doppler
Time Frame
6 Weeks Post-Op
Title
Diameter of the artery 2cm above anastomosis
Description
Measure with the use of an Ultrasound Doppler
Time Frame
6 Weeks Post-Op
Title
Suitability for Cannulation
Description
Measure with the use of an Ultrasound Doppler
Time Frame
6 Weeks Post-Op
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:
Age >=21 to <= 90.
Chronic Kidney Failure patients with Estimated Glomerular Filtration Rate (eGFR) less than 20mls/min.
Haemodialysis is chosen as their modality of renal replacement therapy.
Exclusion Criteria:
Potential fistula vein diameter <= 3mm (with application of tornique) on initial vein mapping.
Known Left ventricular ejection fraction of less than 20% on Echo diagram.
Previous stroke effecting the AVF 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
Tang Tjun Yip
Phone
65767986
Email
tang.tjun.yip@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Irdina Izwani Bte Shrmani
Email
irdina.izwani.shrmani@sgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang Tjun Yip
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lee Qing Wei Shaun
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tang Tjun Yip
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tjun Yip Tang
Phone
65767986
Email
tang.tjun.yip@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Lee Qingwei Shaun
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25379494
Citation
Kong S, Lee KS, Kim J, Jang SH. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery. Ann Rehabil Med. 2014 Oct;38(5):648-57. doi: 10.5535/arm.2014.38.5.648. Epub 2014 Oct 30.
Results Reference
background
PubMed Identifier
23283645
Citation
Salimi F, Majd Nassiri G, Moradi M, Keshavarzian A, Farajzadegan Z, Saleki M, Nikpoor A, Ghane M. Assessment of effects of upper extremity exercise with arm tourniquet on maturity of arteriovenous fistula in hemodialysis patients. J Vasc Access. 2013 Jul-Sep;14(3):239-44. doi: 10.5301/jva.5000123. Epub 2013 Jan 3.
Results Reference
background
PubMed Identifier
23258587
Citation
Uy AL, Jindal RM, Herndon TW, Yuan CM, Abbott KC, Hurst FP. Impact of isometric handgrip exercises on cephalic vein diameter in non-AVF candidates, a pilot study. J Vasc Access. 2013 Apr-Jun;14(2):157-63. doi: 10.5301/jva.5000116. Epub 2012 Dec 12.
Results Reference
background
PubMed Identifier
14586181
Citation
Rus RR, Ponikvar R, Kenda RB, Buturovic-Ponikvar J. Effect of local physical training on the forearm arteries and veins in patients with end-stage renal disease. Blood Purif. 2003;21(6):389-94. doi: 10.1159/000073441.
Results Reference
background
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Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
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