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Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow

Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03886116
Enrollment
40
Registered
2019-03-22
Start date
2018-11-28
Completion date
2021-12-31
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula, End Stage Renal Disease

Keywords

Arteriovenous Fistula, AVF Maturation, Pre Operative exercise

Brief 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. 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.

Interventions

OTHERExercise

3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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%

Design outcomes

Primary

MeasureTime frameDescription
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow jointBaseline, 1 Week Pre-Op, 6 Weeks Post-OpMeasure with the use of an Ultrasound Doppler
Diameter of the Artery - Brachial & RadialBaselineMeasure with the use of an Ultrasound Doppler
Diameter of the Artery used for AVF1 Week Pre-OpMeasure with the use of an Ultrasound Doppler
Change of Blood Flow Rate in the ArteryBaseline, 1 Week Pre-Op, 6 Weeks Post-OpMeasure with the use of an Ultrasound Doppler
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis6 Weeks Post-OpMeasure with the use of an Ultrasound Doppler
Diameter of the artery 2cm above anastomosis6 Weeks Post-OpMeasure with the use of an Ultrasound Doppler
Suitability for Cannulation6 Weeks Post-OpMeasure with the use of an Ultrasound Doppler

Countries

Singapore

Contacts

Primary ContactTang Tjun Yip
tang.tjun.yip@singhealth.com.sg65767986
Backup ContactIrdina Izwani Bte Shrmani
irdina.izwani.shrmani@sgh.com.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026