Chronic Kidney DiseaseNCT02205944
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
A study testing Progressive Handgrip Exercise in people with Chronic Kidney Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Progressive Handgrip Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital - UHN
Toronto, Ontario, M5G 2C4
About this study
Official title: The Impact of Exercise on Vascular Remodeling, Arteriovenous Fistula Creation and Use in Patients With Chronic Kidney Disease: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Progressive Handgrip Exercise
- Keywords
- chronic kidney disease, hemodialysis, vascular access, arteriovenous fistula, forearm exercise
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Handgrip ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Progressive Handgrip Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Ultrasound measurements using duplex ultrasonography
Measured: Baseline, week 9 and week 11
Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels
cGMP and NO will be sampled in blood plasma collected immediately prior to ultrasound assessment
Measured: Baseline, week 9 and week 11
Fistula maturation
A fistula will be deemed mature if either criterion are met: 1) the National Kidney Foundation Disease Outcomes Quality Initiative 'rule of six' , or 2) the draining vein diameter is > 4 mm with intra-access flows > 500 ml/min AND an experienced hemodialysis nurse, blinded to group allocation, deems maturation to have occurred.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charmaine Lok, University Health Network, Toronto
- Investigators
- Charmaine Lok, MD, FRCPC, MSC, Principal investigator, University Health Network, TorontoChris Chan, MD, Principal investigator, University Health Network, TorontoJamie Macdonald, PhD, Principal investigator, Bangor UniversityDavid Cherney, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205944
- Sponsor's protocol ID
- CAPCR-ID: 13-6763-AE
- Status last verified
- Jul 2016
- First submitted
- 9 Jul 2014
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise on Vascular Remodeling, Arteriovenous Fistula Creation and Use in Patients With Chronic Kidney Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02205944
- Acronym / sponsor ID
- CAPCR-ID: 13-6763-AE
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, hemodialysis, vascular access, arteriovenous fistula, forearm exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive routine vascular access pre-op teaching and care. |
| Normal Exercise Group | Experimental | Other: Progressive Handgrip ExerciseGroup 1 (Normal Exercise Group): progressive handgrip exercise Group 2 (Restricted Blood Flow Exercise Group): progressive handgrip exercise with controlled tourniquet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Handgrip ExerciseGroup 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. | Other | Normal Exercise Group |
Primary outcome
Late dialysis suitability failure
Time frame: 6 months after surgery
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.
3 secondary outcomes
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.
Time frame: Baseline, week 9 and week 11
Plasma cGMP (cyclic guanosine monophosphate) and NO (nitric oxide) levels
Time frame: Baseline, week 9 and week 11
Fistula maturation
Time frame: 6 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charmaine Lok, MD, FRCPC, MSC principal investigator
University Health Network, Toronto
Chris Chan, MD principal investigator
University Health Network, Toronto
Jamie Macdonald, PhD principal investigator
Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Handgrip Exercise in people with Chronic Kidney Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy Forrester, RN (416-340-4748, Cathy.Forrester@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late dialysis suitability failure (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.