An interventional study of Exercise in End Stage Renal Disease and Arteriovenous Fistula, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 40 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Exercise
Patient is not required to do any exercise.
3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
Measure with the use of an Ultrasound Doppler
Time frame: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Diameter of the Artery - Brachial & Radial
Measure with the use of an Ultrasound Doppler
Time frame: Baseline
Diameter of the Artery used for AVF
Measure with the use of an Ultrasound Doppler
Time frame: 1 Week Pre-Op
Change of Blood Flow Rate in the Artery
Measure with the use of an Ultrasound Doppler
Time frame: 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
Time frame: 6 Weeks Post-Op
Diameter of the artery 2cm above anastomosis
Measure with the use of an Ultrasound Doppler
Time frame: 6 Weeks Post-Op
Suitability for Cannulation
Measure with the use of an Ultrasound Doppler
Time frame: 6 Weeks Post-Op
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital