End Stage Renal DiseaseNCT03886116
Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
A study testing Exercise in people with End Stage Renal Disease and Arteriovenous Fistula, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- End Stage Renal Disease, Arteriovenous Fistula
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Nov 2018to Dec 2021
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=21 to <= 90.
- Chronic Kidney Failure patients with Estimated Glomerular Filtration Rate (eGFR) less than 20mls/min.
- Haemodialysis is chosen as their modality of renal replacement therapy.
Who cannot join
- Potential fistula vein diameter <= 3mm (with application of tornique) on initial vein mapping.
- Known Left ventricular ejection fraction of less than 20% on Echo diagram.
- Previous stroke effecting the AVF arm.
- Calcified brachial or radial arteries and/or duplex evidence of stenosis of >= 50%
Trial locations and contacts
1 site in 1 country.
Irdina Izwani Bte Shrmani contact
Singapore1 site, 1 recruiting
- Recruiting
Tang Tjun Yip
Singapore
Tjun Yip Tang, 65767986, tang.tjun.yip@singhealth.com.sg
Lee Qingwei Shaun
About this study
This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery.
This is a randomised control study with 20 patients each in the Control arm (Group A) or the Exercise arm (Group B). The subjects will be randomised into 1:1 into one of the two groups.
The patients will have an ultrasound doppler vein mapping done prior surgery and the necessary follow up visits.
Read the detailed description
The incident and prevalent population on renal replacement therapy for End Stage Renal Disease (ESRD) is steadily increasing in Singapore as well as other countries worldwide. Around 85 - 90% of the prevalent dialysis population is on Hemodialysis and Arteriovenous Fistula (AVF).
AVF is considered the Gold standard for safe and effective vascular access for hemodialysis treatment due to its low rates of complication. However, Primary Failure rate of AVFs remain high at around 20 - 25% depending on the site of the surgery, contributed by several factors including the diameter of the artery and the vein used for AVF formation.
If Pre-operative exercise improves the hemodynamics of the AVF and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AVF.
Even though, there is sufficient evidence to support the beneficial role of the forearm exercises on fistula blood flow and maturation, there are no studies looking at the effects of Pre-Operative Exercise on AVF maturation. Our Study is aiming to fulfil this gap in knowledge.
- Conditions
- End Stage Renal Disease, Arteriovenous Fistula
- Being tested
- Exercise
- Keywords
- Arteriovenous Fistula, AVF Maturation, Pre Operative exercise
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Patient randomized are required to squeeze a soft ball 10 times for a set. They are required to perform 3 sets of 10 squeezes each at a 1 Minute interval.
3 sets of exercises to be performed twice in the Morning and Evening, for a total of 6 weeks. Receives: Other: Exercise |
| No Exercise | No intervention | Patient is not required to do any exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
Measure with the use of an Ultrasound Doppler
Measured: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Diameter of the Artery - Brachial & Radial
Measure with the use of an Ultrasound Doppler
Measured: Baseline
Diameter of the Artery used for AVF
Measure with the use of an Ultrasound Doppler
Measured: 1 Week Pre-Op
Change of Blood Flow Rate in the Artery
Measure with the use of an Ultrasound Doppler
Measured: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis
Measure with the use of an Ultrasound Doppler
Measured: 6 Weeks Post-Op
Diameter of the artery 2cm above anastomosis
Measure with the use of an Ultrasound Doppler
Measured: 6 Weeks Post-Op
Suitability for Cannulation
Measure with the use of an Ultrasound Doppler
Measured: 6 Weeks Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start28 Nov 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Singapore General HospitalLee Qing Wei Shaun, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886116
- Sponsor's protocol ID
- 2016/2573
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2019
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong S, Lee KS, Kim J, Jang SH. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery. Ann Rehabil Med. 2014 Oct;38(5):648-57. doi: 10.5535/arm.2014.38.5.648. Epub 2014 Oct 30.
PubMed 25379494Salimi F, Majd Nassiri G, Moradi M, Keshavarzian A, Farajzadegan Z, Saleki M, Nikpoor A, Ghane M. Assessment of effects of upper extremity exercise with arm tourniquet on maturity of arteriovenous fistula in hemodialysis patients. J Vasc Access. 2013 Jul-Sep;14(3):239-44. doi: 10.5301/jva.5000123. Epub 2013 Jan 3.
PubMed 23283645Uy AL, Jindal RM, Herndon TW, Yuan CM, Abbott KC, Hurst FP. Impact of isometric handgrip exercises on cephalic vein diameter in non-AVF candidates, a pilot study. J Vasc Access. 2013 Apr-Jun;14(2):157-63. doi: 10.5301/jva.5000116. Epub 2012 Dec 12.
PubMed 23258587Rus RR, Ponikvar R, Kenda RB, Buturovic-Ponikvar J. Effect of local physical training on the forearm arteries and veins in patients with end-stage renal disease. Blood Purif. 2003;21(6):389-94. doi: 10.1159/000073441.
PubMed 14586181
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
- ClinicalTrials.gov ID
- NCT03886116
- Acronym / sponsor ID
- 2016/2573
- Conditions
- End Stage Renal Disease, Arteriovenous Fistula
- Keywords
- Arteriovenous Fistula, AVF Maturation, Pre Operative exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Mar 2019 (actual)
- 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.
This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery.
This is a randomised control study with 20 patients each in the Control arm (Group A) or the Exercise arm (Group B). The subjects will be randomised into 1:1 into one of the two groups.
The patients will have an ultrasound doppler vein mapping done prior surgery and the necessary follow up visits.
Detailed description
The incident and prevalent population on renal replacement therapy for End Stage Renal Disease (ESRD) is steadily increasing in Singapore as well as other countries worldwide. Around 85 - 90% of the prevalent dialysis population is on Hemodialysis and Arteriovenous Fistula (AVF).
AVF is considered the Gold standard for safe and effective vascular access for hemodialysis treatment due to its low rates of complication. However, Primary Failure rate of AVFs remain high at around 20 - 25% depending on the site of the surgery, contributed by several factors including the diameter of the artery and the vein used for AVF formation.
If Pre-operative exercise improves the hemodynamics of the AVF and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AVF.
Even though, there is sufficient evidence to support the beneficial role of the forearm exercises on fistula blood flow and maturation, there are no studies looking at the effects of Pre-Operative Exercise on AVF maturation. Our Study is aiming to fulfil this gap in knowledge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: ExercisePatient randomized are required to squeeze a soft ball 10 times for a set. They are required to perform 3 sets of 10 squeezes each at a 1 Minute interval. 3 sets of exercises to be performed twice in the Morning and Evening, for a total of 6 weeks. |
| No Exercise | No intervention | –Patient is not required to do any exercise. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >=21 to <= 90.
- Chronic Kidney Failure patients with Estimated Glomerular Filtration Rate (eGFR) less than 20mls/min.
- Haemodialysis is chosen as their modality of renal replacement therapy.
Key exclusion criteria (4 listed)
- Potential fistula vein diameter <= 3mm (with application of tornique) on initial vein mapping.
- Known Left ventricular ejection fraction of less than 20% on Echo diagram.
- Previous stroke effecting the AVF arm.
- Calcified brachial or radial arteries and/or duplex evidence of stenosis of >= 50%
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 |
|---|---|---|
| Exercise3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks. | Other | Exercise |
Primary outcome
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
Time frame: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Diameter of the Artery - Brachial & Radial
Time frame: Baseline
Measure with the use of an Ultrasound Doppler
Diameter of the Artery used for AVF
Time frame: 1 Week Pre-Op
Measure with the use of an Ultrasound Doppler
Change of Blood Flow Rate in the Artery
Time frame: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis
Time frame: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Diameter of the artery 2cm above anastomosis
Time frame: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Suitability for Cannulation
Time frame: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 25379494Kong S, Lee KS, Kim J, Jang SH. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery. Ann Rehabil Med. 2014 Oct;38(5):648-57. doi: 10.5535/arm.2014.38.5.648. Epub 2014 Oct 30.
- Background: PubMed 23283645Salimi F, Majd Nassiri G, Moradi M, Keshavarzian A, Farajzadegan Z, Saleki M, Nikpoor A, Ghane M. Assessment of effects of upper extremity exercise with arm tourniquet on maturity of arteriovenous fistula in hemodialysis patients. J Vasc Access. 2013 Jul-Sep;14(3):239-44. doi: 10.5301/jva.5000123. Epub 2013 Jan 3.
- Background: PubMed 23258587Uy AL, Jindal RM, Herndon TW, Yuan CM, Abbott KC, Hurst FP. Impact of isometric handgrip exercises on cephalic vein diameter in non-AVF candidates, a pilot study. J Vasc Access. 2013 Apr-Jun;14(2):157-63. doi: 10.5301/jva.5000116. Epub 2012 Dec 12.
- Background: PubMed 14586181Rus RR, Ponikvar R, Kenda RB, Buturovic-Ponikvar J. Effect of local physical training on the forearm arteries and veins in patients with end-stage renal disease. Blood Purif. 2003;21(6):389-94. doi: 10.1159/000073441.
- Individual participant dataSharing planned: No
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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.
Irdina Izwani Bte Shrmani contact
Tang Tjun Yip principal investigator
Singapore General Hospital
Lee Qing Wei Shaun principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with End Stage Renal Disease and Arteriovenous Fistula, run by Singapore General Hospital at 1 site in Singapore.
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 3 inclusion and 4 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 27 Sep 2021. 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 Singapore. 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 Tang Tjun Yip (65767986, tang.tjun.yip@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint (time frame: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886116, which also lists 4 linked publications.
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 27 Sep 2021.