Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

Not Applicable

• Conditions: Chronic Kidney Disease
• Interventions: Other: Progressive Handgrip Exercise

• Registration Number: NCT02205944
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Study Start: 2014-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-04
• Last Update Posted: 2016-07-06
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Adult (age>18 years old) with chronic kidney disease
2. Hemodialysis is their renal replacement therapy (RRT) modality
3. Deemed eligible for an arteriovenous fistula
4. Anticipated RRT start < 3 months (from the time of vascular surgery assessment) if predialysis
5. Scheduled surgical creation of fistula aniticpated >= 8 weeks
6. Able to follow instructions for an exercise intervention
7. Able to provide informed written consent

Exclusion Criteria

1. Life expectancy < 6 months

2. Need for urgent vascular access (i.e. <4 weeks)

3. Pre-existing fistula distal to site of newly scheduled fistula

4. Ipsilateral central stenosis or occlusions not amenable to correction

5. 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

6. Contraindications to general exercise

   • Poorly controlled blood pressure - SBP>180, DBP>90; SBP<110, DBP<50
   • NYHC IV heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Exercise Group	Progressive Handgrip Exercise	Group 1 (Normal Exercise Group): progressive handgrip exercise Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet

Primary Outcome Measures

Name	Time	Method
Late dialysis suitability failure	6 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
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.	Baseline, week 9 and week 11	Ultrasound measurements using duplex ultrasonography
Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels	Baseline, week 9 and week 11	cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment
Fistula maturation	6 weeks after surgery	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.

Trial Locations

Locations (1)

Toronto General Hospital - UHN; 🇨🇦 Toronto, Ontario, Canada