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

September 23, 2021 updated by: Singapore General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise

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
3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.
No Intervention: No Exercise
Patient is not required to do any exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint
Time Frame: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Diameter of the Artery - Brachial & Radial
Time Frame: Baseline
Measure with the use of an Ultrasound Doppler
Baseline
Diameter of the Artery used for AVF
Time Frame: 1 Week Pre-Op
Measure with the use of an Ultrasound Doppler
1 Week Pre-Op
Change of Blood Flow Rate in the Artery
Time Frame: Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
Baseline, 1 Week Pre-Op, 6 Weeks Post-Op
Diameter of the fistula vein at 5cm, 10cm & 15cm from anastomosis
Time Frame: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
6 Weeks Post-Op
Diameter of the artery 2cm above anastomosis
Time Frame: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
6 Weeks Post-Op
Suitability for Cannulation
Time Frame: 6 Weeks Post-Op
Measure with the use of an Ultrasound Doppler
6 Weeks Post-Op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Tang Tjun Yip, Singapore General Hospital
  • Principal Investigator: Lee Qing Wei Shaun, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/2573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe