Arteriovenous FistulaNCT03137680
Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration
A study testing Hand Exercise in people with Arteriovenous Fistula, run by Changi General Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Hand Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2017to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Kidney failure patients with eGFR less than 20mls/min
- Chosen Hemodailysis as their modality of renal replacement therapy
Who cannot join
- 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%
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow
To investigate the effect of pre-operative exercise on
- Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
- Suitability of cannulation of AV fistula at 8weeks
Read the 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.
- Conditions
- Arteriovenous Fistula
- Being tested
- Hand Exercise
- Keywords
- Arteriovenous Fistula, Pre-operative Exercise, Fistula Maturation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Hand Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 22 weeks
Secondary outcomes (2)
Suitability of cannulation of AV fistula
Assessment of suitability of AV fistula cannulation by blinded vascular surgeon 8 week post creation
Measured: 8 Weeks
Secondary fistula failure
Fistula outcomes will be assessed to review the need for angiographic procedures for AVF maturation and also look at secondary fistula failure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start15 May 2017 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion20 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sreekanth Koduri, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137680
- Sponsor's protocol ID
- 2016/2573
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36184076
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow
- ClinicalTrials.gov ID
- NCT03137680
- Acronym / sponsor ID
- 2016/2573
- Conditions
- Arteriovenous Fistula
- Keywords
- Arteriovenous Fistula, Pre-operative Exercise, Fistula Maturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 20 Mar 2019 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of pre-operative exercise on
- Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –No specific exercise regime for the control group. Usual hospital SOP will be adhered to |
| Exercise Arm | Experimental | Behavioral: Hand ExerciseThe 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 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Kidney failure patients with eGFR less than 20mls/min
- Chosen Hemodailysis as their modality of renal replacement therapy
Key exclusion criteria (4 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand ExerciseExercise 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. | Behavioural | Exercise Arm |
Primary outcome
Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
Time frame: 22 weeks
AV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared
2 secondary outcomes
Suitability of cannulation of AV fistula
Time frame: 8 Weeks
Secondary fistula failure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 36184076Nantakool 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.
- Individual participant dataSharing planned: Undecided
Related trials for Arteriovenous Fistula
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Exercise in people with Arteriovenous Fistula, run by Changi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sreekanth Koduri (85680120, Sreekanth_Koduri@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamics in the fistula artery and vein, pre and post AV fistula formation (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.