Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
NCT ID: NCT02205944
Last Updated: 2016-07-06
Study Results
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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UNKNOWN
NA
210 participants
INTERVENTIONAL
2014-09-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control Group
The control group will receive routine vascular access pre-op teaching and care.
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
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Charmaine Lok
Professor of Medicine, University of Toronto
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
Countries
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Central Contacts
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Other Identifiers
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CAPCR-ID: 13-6763-AE
Identifier Type: -
Identifier Source: org_study_id
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