Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

• Sponsor: Changi General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03137680
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 22.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Arteriovenous Fistula	Behavioral: Hand Exercise	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Care Provider)
• Masking Description: Care Provider i.e., vascular surgeon are blinded to subject randomisation
• Primary Purpose: Treatment
• Official Title: Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow
• Anticipated Study Start Date: May 15, 2017
• Anticipated Primary Completion Date: Dec 15, 2018
• Anticipated Study Completion Date: Mar 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Hemodynamics in the fistula artery and vein, pre and post AV fistula formation [22 weeks]

   AV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared

Secondary Outcome Measures

1. Suitability of cannulation of AV fistula [8 Weeks]

   Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation

2. Secondary fistula failure [1 year]

   Fistula outcomes will be assessed to review the need for angiographic procedures for AVF maturation and also look at secondary fistula failure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Changi General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sreekanth Koduri, Consultant, Changi General Hospital
• ClinicalTrials.gov Identifier: NCT03137680
• Other Study ID Numbers: 2016/2573
• First Posted: May 3, 2017
• Last Update Posted: May 3, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sreekanth Koduri, Consultant, Changi General Hospital: Arteriovenous Fistula; Pre-operative Exercise; Fistula Maturation
• Additional relevant MeSH terms: Arteriovenous Fistula; Fistula

Study Results

No Results Posted as of May 3, 2017