Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02205944
• Other study ID #: CAPCR-ID: 13-6763-AE
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: July 4, 2016
• Start date: September 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2016
• Source: University Health Network, Toronto
• Contact: Cathy Forrester, RN
• Phone: 416-340-4748
• Email: Cathy.Forrester[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Study Steering Committee - Toronto General Hospital Research Institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Fistula
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital - UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No