Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

Arteriovenous Fistula Clinical Trial

Official title:

Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03137680
• Other study ID #: 2016/2573
• Status: Not yet recruiting
• Phase: N/A
• First received: April 28, 2017
• Last updated: April 28, 2017
• Start date: May 15, 2017
• Est. completion date: March 20, 2019

Study information

• Verified date: April 2017
• Source: Changi General Hospital
• Contact: Sreekanth Koduri
• Phone: 85680120
• Email: Sreekanth_Koduri[@]cgh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of pre-operative exercise on

1. Hemodynamics in the fistula artery and vein, pre and post AV fistula formation

2. Suitability of cannulation of AV fistula at 8weeks

Description:

Aim: To investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, pre and post AV fistula formation as well as the suitability of cannulation of AV fistula at 8weeks post sugery

Methodology: This is a randomised control study with 20 patients each in the exercise arm and the control arm. The subjects will be randomised 1:1 into one of the two groups. Chronic Kidney failure patients with eGFR less than 20mls/min and have chosen Haemodialysis as their modality of renal replacement therapy will be included the study. All the subjects will have an ultrasound doppler vein mapping done prior to entering the study.

The exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks.

All patients will have a follow up ultrasound doppler of the AV fistula at 8 weeks and 16 weeks post-surgery, looking at the AV fistula vein diameter, arterial diameter and blood flow rate. All the subjects will also be seen by a single vascular surgeon following the scan, to assess the suitability for AVF cannulation.

Significance of the proposed study and benefits: A well functioning arterio-venous fistula is the gold standard vascular access for Hemodialysis patients due to its low rates of complications. The primary failure rate of the AVFs remain high at around 20 -25%, contributed by several factors including the diameter of the vessels. If pre-operative exercise improves the hemodynamics of the AV fistula and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AV fistulas.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 20, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Chronic Kidney failure patients with eGFR less than 20mls/min

2. Chosen Hemodailysis as their modality of renal replacement therapy

Exclusion Criteria:

1. Potential fistula vein diameter less than 3mm (with application of tornique) on initial vein mapping

2. Known left ventricular ejection fraction of less than 20% on Echocardiogram

3. Previous stroke effecting the AV fistula arm

4. Calcified brachial or radial arteries and/or duplex evidence of stenosis of >50%

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Behavioral:
• Hand Exercise
Exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamics in the fistula artery and vein, pre and post AV fistula formation	AV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared	22 weeks
Secondary	Suitability of cannulation of AV fistula	Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation	8 Weeks
Secondary	Secondary fistula failure	Fistula outcomes will be assessed to review the need for angiographic procedures for AVF maturation and also look at secondary fistula failure	1 year