Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow

Conditions
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End Stage Renal Disease, Arteriovenous Fistula

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>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. | Other: Exercise<br>* 3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.<br>|
| No Intervention: No Exercise<br>Patient is not required to do any exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint | Measure with the use of an Ultrasound Doppler | Baseline, 1 Week Pre-Op, 6 Weeks Post-Op | 
| Diameter of the Artery - Brachial & Radial | Measure with the use of an Ultrasound Doppler | Baseline | 
| Diameter of the Artery used for AVF | Measure with the use of an Ultrasound Doppler | 1 Week Pre-Op | 
| Change of Blood Flow Rate in the Artery | Measure with the use of an Ultrasound Doppler | Baseline, 1 Week Pre-Op, 6 Weeks Post-Op | 
| Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis | Measure with the use of an Ultrasound Doppler | 6 Weeks Post-Op | 
| Diameter of the artery 2cm above anastomosis | Measure with the use of an Ultrasound Doppler | 6 Weeks Post-Op | 
| Suitability for Cannulation | Measure with the use of an Ultrasound Doppler | 6 Weeks Post-Op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous Fistula, AVF Maturation, Pre Operative exercise