Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes

NCT ID: NCT02205944

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Normal Exercise Group

Group 1 (Normal Exercise Group): progressive handgrip exercise

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

Group Type EXPERIMENTAL

Progressive Handgrip Exercise

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Charmaine Lok

Professor of Medicine, University of Toronto

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charmaine Lok, MD, FRCPC, MSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Chris Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Jamie Macdonald, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangor University

David Cherney, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital - UHN

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Cathy Forrester, RN

Role: CONTACT

416-340-4748

Other Identifiers

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CAPCR-ID: 13-6763-AE

Identifier Type: -

Identifier Source: org_study_id

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