Clinical trial NCT02205944: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
hemodialysis
vascular access
arteriovenous fistula
forearm exercise
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Late dialysis suitability failure
timeFrame: 6 months after surgery
Secondary outcomes:
measure: 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.
timeFrame: Baseline, week 9 and week 11
measure: Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels
timeFrame: Baseline, week 9 and week 11
measure: Fistula maturation
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital - UHN
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Charmaine Lok, MD, FRCPC, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Chris Chan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangor University
name: Jamie Macdonald, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: David Cherney, MD
role: PRINCIPAL_INVESTIGATOR
References: