Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease, hemodialysis, vascular access, arteriovenous fistula, forearm exercise
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.
Interventions
OTHERProgressive 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late dialysis suitability failure | 6 months after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline, week 9 and week 11 | Ultrasound measurements using duplex ultrasonography |
| Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels | Baseline, week 9 and week 11 | cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment |
| Fistula maturation | 6 weeks after surgery | 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. |
Countries
Canada
Contacts
Primary ContactCathy Forrester, RN
Outcome results
None listed