Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

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

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

Study Overview

• Status: Unknown
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Behavioral: Hand Exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; No specific exercise regime for the control group. Usual hospital SOP will be adhered to
Experimental: Exercise Arm; 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 6 weeks. This will be performed at least 6 weeks prior to the creation of the AV fistula	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suitability of cannulation of AV fistula	Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation	8 Weeks
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

Collaborators and Investigators

• Sponsor: Changi General Hospital

Publications and helpful links

General Publications

• Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2017
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): March 20, 2019

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Arteriovenous Fistula; Pre-operative Exercise; Fistula Maturation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2016/2573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No