Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

NCT03137680 | Unknown DMC

• 1 other identifier: 2016/2573
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the effect of pre-operative exercise on

1. 1.Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
2. 2.Suitability of cannulation of AV fistula at 8weeks

Conditions

Arteriovenous Fistula

Keywords

Arteriovenous Fistula; Pre-operative Exercise; Fistula Maturation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Suitability of cannulation of AV fistula

  8 Weeks

• Secondary fistula failure

  1 year

Study Arms (2)

Control Arm

NO INTERVENTION

No specific exercise regime for the control group. Usual hospital SOP will be adhered to

Exercise Arm

EXPERIMENTAL

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

Interventions

Hand Exercise BEHAVIORAL

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.

Exercise Arm

Eligibility Criteria

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

You may qualify if:

• Chronic Kidney failure patients with eGFR less than 20mls/min
• Chosen Hemodailysis as their modality of renal replacement therapy

You may not qualify if:

• Potential fistula vein diameter less than 3mm (with application of tornique) on initial vein mapping
• Known left ventricular ejection fraction of less than 20% on Echocardiogram
• Previous stroke effecting the AV fistula arm
• Calcified brachial or radial arteries and/or duplex evidence of stenosis of \>50%

Sponsors & Collaborators

• Changi General Hospital: lead

Related Publications (1)

• 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.

  PMID: 36184076 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sreekanth Koduri

CONTACT

85680120; Sreekanth_Koduri@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care Provider i.e., vascular surgeon are blinded to subject randomisation
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 3, 2017
• Study Start: May 15, 2017
• Primary Completion: December 15, 2018
• Study Completion: March 20, 2019
• Last Updated: May 3, 2017

Record last verified: 2017-04