Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

Study Overview
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Brief Summary
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The purpose of this research study is to determine whether two different types of forearm exercise, performed before fistula creation surgery, can improve surgery success and fistula maturation.

Detailed Description
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This is a randomized, double blinded controlled trial to study the impact of handgrip exercise prior to surgical creation of hemodialysis fistula on vascular remodelling and fistula maturation in chronic kidney disease patients.

Official Title
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The Impact of Exercise on Vascular Remodeling, Arteriovenous Fistula Creation and Use in Patients With Chronic Kidney Disease: A Randomized Controlled Trial

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Progressive Handgrip Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age>18 years old) with chronic kidney disease Hemodialysis is their renal replacement therapy (RRT) modality Deemed eligible for an arteriovenous fistula Anticipated RRT start < 3 months (from the time of vascular surgery assessment) if predialysis Scheduled surgical creation of fistula aniticpated >= 8 weeks Able to follow instructions for an exercise intervention Able to provide informed written consent Exclusion Criteria: Life expectancy < 6 months Need for urgent vascular access (i.e. <4 weeks) Pre-existing fistula distal to site of newly scheduled fistula Ipsilateral central stenosis or occlusions not amenable to correction Contraindications or unable to perform handgrip exercise Unable to withstand transiently raised systolic blood pressure (SBP) by 35 mmHg, and diastolic (DBP) by 25 mmHg severe upper extremity arthritis or other pain Contraindications to general exercise Poorly controlled blood pressure - SBP>180, DBP>90; SBP<110, DBP<50 NYHC IV heart failure

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The control group will receive routine vascular access pre-op teaching and care. | |
| Experimental: Normal Exercise Group<br>Group 1 (Normal Exercise Group): progressive handgrip exercise Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet | Other: Progressive Handgrip Exercise<br>* Group 1 (Normal Exercise Group): Daily, at home for 20 minutes using an adjustable handgrip trainer up to 8 weeks prior to a scheduled surgery for fistula creation. The exercise intensity is tailored using the Borg CR100 scale (Borg & Borg, 2001). Group 2 (Restricted Blood Flow Exercise Group): Same as the exercise performed by Group 1 with controlled tourniquet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late dialysis suitability failure | Late dialysis suitability failure is a fistula that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the sixth month following its creation. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of intra-access flow and vascular diameters at predetermined distances from the fistula anastomosis; arterial stiffness and endothelial function on a randomly determined sub sample of patients. | Ultrasound measurements using duplex ultrasonography | Baseline, week 9 and week 11 | 
| Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels | cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment | Baseline, week 9 and week 11 | 
| Fistula maturation | A fistula will be deemed mature if either criterion are met: 1) the National Kidney Foundation Disease Outcomes Quality Initiative 'rule of six' , or 2) the draining vein diameter is > 4 mm with intra-access flows > 500 ml/min AND an experienced hemodialysis nurse, blinded to group allocation, deems maturation to have occurred. | 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, hemodialysis, vascular access, arteriovenous fistula, forearm exercise