Recruiting

Presurgical Exercise

Sponsor:

University Health Network, Toronto

Code:

NCT02205944

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Progressive Handgrip Exercise

Study Details

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

Study ID

NCT02205944

Start date

Sep, 2014

Status verified date

Jul, 2016

Completion date

Mar, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Group

The control group will receive routine vascular access pre-op teaching and care.

experimental: Normal Exercise Group

Group 1 (Normal Exercise Group): progressive handgrip exercise

Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet

Interventions

Progressive 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.

Primary outcome measure

  • Late dialysis suitability failure [ Time Frame: 6 months after surgery ]

Central Contacts and Locations

Central contacts

Cathy Forrester, RN

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

Locations

Toronto General Hospital - UHN

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 6, 2016

Last verified

Jul, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2016-07-06.