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

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ClinicalTrials.gov Identifier: NCT03886116
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Arteriovenous Fistula Other: Exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Diameter of the Artery - Brachial & Radial [ Time Frame: Baseline ]
    Measure with the use of an Ultrasound Doppler

  3. Diameter of the Artery used for AVF [ Time Frame: 1 Week Pre-Op ]
    Measure with the use of an Ultrasound Doppler

  4. 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

  5. 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. Diameter of the artery 2cm above anastomosis [ Time Frame: 6 Weeks Post-Op ]
    Measure with the use of an Ultrasound Doppler

  7. Suitability for Cannulation [ Time Frame: 6 Weeks Post-Op ]
    Measure with the use of an Ultrasound Doppler


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886116


Contacts
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Contact: Tang Tjun Yip 65767986 tang.tjun.yip@singhealth.com.sg
Contact: Irdina Izwani Bte Shrmani irdina.izwani.shrmani@sgh.com.sg

Locations
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Singapore
Tang Tjun Yip Recruiting
Singapore, Singapore
Contact: Tjun Yip Tang    65767986    tang.tjun.yip@singhealth.com.sg   
Sub-Investigator: Lee Qingwei Shaun         
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Tang Tjun Yip Singapore General Hospital
Principal Investigator: Lee Qing Wei Shaun Singapore General Hospital
More Information
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Publications:

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03886116    
Other Study ID Numbers: 2016/2573
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Arteriovenous Fistula
AVF Maturation
Pre Operative exercise
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Arteriovenous Fistula
Fistula
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Renal Insufficiency
 Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities