Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

University Health Network, Toronto

Status: Unknown

Conditions: Chronic Kidney Disease

Treatments: Other: Progressive Handgrip Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02205944

CAPCR-ID: 13-6763-AE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

Normal Exercise Group

Experimental group

Description:

Group 1 (Normal Exercise Group): progressive handgrip exercise Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet

Treatment:

Other: Progressive Handgrip Exercise