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Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration

Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03137680
Enrollment
40
Registered
2017-05-03
Start date
2017-05-15
Completion date
2019-03-20
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula

Keywords

Arteriovenous Fistula, Pre-operative Exercise, Fistula Maturation

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

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.

Interventions

BEHAVIORALHand 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.

Sponsors

Changi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

Care Provider i.e., vascular surgeon are blinded to subject randomisation

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
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%

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamics in the fistula artery and vein, pre and post AV fistula formation22 weeksAV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared

Secondary

MeasureTime frameDescription
Suitability of cannulation of AV fistula8 WeeksAssessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation
Secondary fistula failure1 yearFistula outcomes will be assessed to review the need for angiographic procedures for AVF maturation and also look at secondary fistula failure

Contacts

Primary ContactSreekanth Koduri
Sreekanth_Koduri@cgh.com.sg85680120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026