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

NCT03886116 | Unknown

• 1 other identifier: 2016/2573
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Arteriovenous Fistula

Keywords

Arteriovenous Fistula; AVF Maturation; Pre Operative exercise

Outcome Measures

Primary Outcomes (7)

• Change of Diameter of the vein at 5cm, 10cm & 15cm from wrist joint/elbow joint

  Measure with the use of an Ultrasound Doppler

  Baseline, 1 Week Pre-Op, 6 Weeks Post-Op

• Diameter of the Artery - Brachial & Radial

  Measure with the use of an Ultrasound Doppler

  Baseline

• Diameter of the Artery used for AVF

  Measure with the use of an Ultrasound Doppler

  1 Week Pre-Op

• Change of Blood Flow Rate in the Artery

  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

  Measure with the use of an Ultrasound Doppler

  6 Weeks Post-Op

• Diameter of the artery 2cm above anastomosis

  Measure with the use of an Ultrasound Doppler

  6 Weeks Post-Op

• Suitability for Cannulation

  Measure with the use of an Ultrasound Doppler

  6 Weeks Post-Op

Study Arms (2)

Exercise

ACTIVE COMPARATOR

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

No Exercise

NO INTERVENTION

Patient is not required to do any exercise.

Interventions

Exercise OTHER

3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.

Exercise

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Tang Tjun Yip

Singapore, Singapore

RECRUITING

Related Publications (4)

• Kong S, Lee KS, Kim J, Jang SH. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery. Ann Rehabil Med. 2014 Oct;38(5):648-57. doi: 10.5535/arm.2014.38.5.648. Epub 2014 Oct 30.

  PMID: 25379494 BACKGROUND

• Salimi F, Majd Nassiri G, Moradi M, Keshavarzian A, Farajzadegan Z, Saleki M, Nikpoor A, Ghane M. Assessment of effects of upper extremity exercise with arm tourniquet on maturity of arteriovenous fistula in hemodialysis patients. J Vasc Access. 2013 Jul-Sep;14(3):239-44. doi: 10.5301/jva.5000123. Epub 2013 Jan 3.

  PMID: 23283645 BACKGROUND

• Uy AL, Jindal RM, Herndon TW, Yuan CM, Abbott KC, Hurst FP. Impact of isometric handgrip exercises on cephalic vein diameter in non-AVF candidates, a pilot study. J Vasc Access. 2013 Apr-Jun;14(2):157-63. doi: 10.5301/jva.5000116. Epub 2012 Dec 12.

  PMID: 23258587 BACKGROUND

• Rus RR, Ponikvar R, Kenda RB, Buturovic-Ponikvar J. Effect of local physical training on the forearm arteries and veins in patients with end-stage renal disease. Blood Purif. 2003;21(6):389-94. doi: 10.1159/000073441.

  PMID: 14586181 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tang Tjun Yip

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Lee Qing Wei Shaun

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tang Tjun Yip

CONTACT

65767986; tang.tjun.yip@singhealth.com.sg

Irdina Izwani Bte Shrmani

CONTACT

irdina.izwani.shrmani@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 22, 2019
• Study Start: November 28, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)