Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

N/AUnknownNCT02205944

University Health Network, Toronto210 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

210

Conditions

Chronic Kidney Disease

Interventions

Progressive Handgrip ExerciseOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Toronto General Hospital - UHN

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 months after surgery

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 6 weeks after surgery

Central Contacts

Cathy Forrester, RN

CONTACT

416-340-4748 Cathy.Forrester@uhn.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.