Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Behavioral: Hand Exercise


Participation Criteria
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Eligibility Criteria
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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%

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>No specific exercise regime for the control group. Usual hospital SOP will be adhered to | |
| Experimental: Exercise Arm<br>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 | Behavioral: Hand Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suitability of cannulation of AV fistula | Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation | 8 Weeks | 
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous Fistula, Pre-operative Exercise, Fistula Maturation