Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

NCT02205944 | Unknown

• 1 other identifier: CAPCR-ID: 13-6763-AE
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; hemodialysis; vascular access; arteriovenous fistula; forearm exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels

  Baseline, week 9 and week 11

• Fistula maturation

  6 weeks after surgery

Study Arms (2)

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

Other: Progressive Handgrip Exercise

Interventions

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.

Normal Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age\>18 years old) with chronic kidney disease
• Hemodialysis is their renal replacement therapy (RRT) modality
• Deemed eligible for an arteriovenous fistula
• Anticipated RRT start \< 3 months (from the time of vascular surgery assessment) if predialysis
• Scheduled surgical creation of fistula aniticpated \>= 8 weeks
• Able to follow instructions for an exercise intervention
• Able to provide informed written consent

You may not qualify if:

• 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
• 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
• Contraindications to general exercise
• Poorly controlled blood pressure - SBP\>180, DBP\>90; SBP\<110, DBP\<50
• NYHC IV heart failure

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital - UHN

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Charmaine Lok, MD, FRCPC, MSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Chris Chan, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Jamie Macdonald, PhD

  Bangor University

  PRINCIPAL INVESTIGATOR

• David Cherney, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Forrester, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, University of Toronto

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: August 1, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

CA (1)