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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group will receive routine vascular access pre-op teaching and care. | |
| Normal Exercise Group | Experimental | Group 1 (Normal Exercise Group): progressive handgrip exercise Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Handgrip Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels |
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Inclusion Criteria:
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
Contraindications to general exercise
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathy Forrester, RN | Contact | 416-340-4748 | Cathy.Forrester@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Charmaine Lok, MD, FRCPC, MSC | University Health Network, Toronto | Principal Investigator |
| Chris Chan, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital - UHN | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment |
| 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. | 6 weeks after surgery |
| Jamie Macdonald, PhD |
| Bangor University |
| Principal Investigator |
| David Cherney, MD | University Health Network, Toronto | Principal Investigator |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |