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Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Progressive Handgrip Exercise
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, hemodialysis, vascular access, arteriovenous fistula, forearm exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto General Hospital - UHNRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Normal Exercise Group

Arm Description

The control group will receive routine vascular access pre-op teaching and care.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
July 9, 2014
Last Updated
July 4, 2016
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02205944
Brief Title
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
Official Title
The Impact of Exercise on Vascular Remodeling, Arteriovenous Fistula Creation and Use in Patients With Chronic Kidney Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, hemodialysis, vascular access, arteriovenous fistula, forearm exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive routine vascular access pre-op teaching and care.
Arm Title
Normal Exercise Group
Arm Type
Experimental
Arm Description
Group 1 (Normal Exercise Group): progressive handgrip exercise Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet
Intervention Type
Other
Intervention Name(s)
Progressive Handgrip Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Late dialysis suitability failure
Description
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.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
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.
Description
Ultrasound measurements using duplex ultrasonography
Time Frame
Baseline, week 9 and week 11
Title
Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels
Description
cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment
Time Frame
Baseline, week 9 and week 11
Title
Fistula maturation
Description
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.
Time Frame
6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Forrester, RN
Phone
416-340-4748
Email
Cathy.Forrester@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charmaine Lok, MD, FRCPC, MSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Chan, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamie Macdonald, PhD
Organizational Affiliation
Bangor University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Cherney, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital - UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

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