Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Progressive Handgrip Exercise

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital - UHN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will receive routine vascular access pre-op teaching and care.
Experimental: Normal Exercise Group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Charmaine Lok, MD, FRCPC, MSC, University Health Network, Toronto; Principal Investigator: Chris Chan, MD, University Health Network, Toronto; Principal Investigator: Jamie Macdonald, PhD, Bangor University; Principal Investigator: David Cherney, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 4, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: chronic kidney disease; hemodialysis; arteriovenous fistula; vascular access; forearm exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: CAPCR-ID: 13-6763-AE