ISRCTN - ISRCTN15802482: Effect of a postoperative exercise program on arteriovenous fistula maturation

Plain English Summary

Background and study aims
An arteriovenous fistula (AVF) is a connection of an artery to a vein. It causes extra pressure and blood flow into the vein, making it grow larger and providing easy access to blood vessels. It is still the method of choice for achieving vascular access (i.e. a surgically created vein used to remove blood from, and return blood to, the body) during dialysis for patients with advanced kidney failure, as it causes fewer complications (such as infections, thrombosis and even death) than other methods. However, central venous catheters (where a catheter is placed in a large vein in the neck, chest or groin) is still widely used, probably due to a delay in creating the AVF and problems with the maturation process (the time between the AVF is created and when it can used, which usually is about 1 month). It is therefore crucial to increase the maturation and use of AVF. Exercises in the pre- and postoperative period have been recommended by current vascular access guidelines as helpful to improve vascular access maturation, increasing flow and muscle mass, decreasing superficial fat, and enhancing vein prominence (size). Currently, preoperative exercise can increase the diameter of a vein and this is linked to an increase in AVF maturation. However, postoperative exercise programs (after AVF creation) have not been clearly shown to be useful. Only one study has looked at the effect of exercise after AVF creation and this had severe limitations (few patients, excessive early examinations and very low maturation rates). The aim of this study is to determine whether a postoperative exercise program can really increase AVF maturation at 1 month, and determine if exercises after AVF creation should or should not be recommended.

Who can participate?
Patients of all ages with advanced chronic kidney disease needing dialysis and candidates for a AVF.

What does the study involve?
After each patient have had AVF surgery, they are randomly allocated into one of two groups. Those in group 1 (exercise group) are asked to follow a specific exercise programme. Those in group 2 (control group) are asked not to perform specific exercises and follow their usual lifestyle. We then investigate AVF maturation for all patients in both groups after 1 month via physical examination and ultrasound.

What are the possible benefits and risks of participating?
There are no benefits or risks associated to taking part to our study, more than the possible (and investigated) benefit related to exercise itself.

Where is the study run from?
Hospital Clinic of Barcelona (Spain)

When is the study starting and how long is it expected to run for?
November 2012 to November 2014

Who is funding the study?
Hospital Clinic of Barcelona (Spain)

Who is the main contact?
Dr Nestor Fontsere
FONTSERE@clinic.ub.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nestor Fontsere

ORCID ID

http://orcid.org/0000-0001-9598-9277

Contact details

Hospital Clinic
C\Villarroel 170
Barcelona
08036
Spain
932275400
FONTSERE@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Hospital Clinic Investigational Committee registration: 2013/8042 (Hospital Clinic, Barcelona, Spain)

Study information

Scientific title

Effect of a postoperative exercise program on arteriovenous fistula maturation: a randomized controlled trial

Acronym

Study hypothesis

A postoperative exercise program increase arteriovenous fistula maturation after its surgical creation

Ethics approval

Hospital Clinic CEIC (Ethical Committee of Clinical Investigation) and Investigational Committee, 10/01/2013, ref: 2013/8042

Study design

A single-center randomized controlled trial (interventional) was designed, including all patients visited in our center, who were candidates to arteriovenous fistula creation. After this surgery, patients were randomized to exercise group (following a controlled postoperative exercise programÇ) or to control group (following usual life-style)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet.

Condition

Arteriovenous fistula is a surgically connection between an artery and a vein, that is created as a method for achieving vascular access in chronic hemodialysis patients.

Intervention

After arteriovenous fistula creation, all patients will be randomized to an exercise or control group. Patients in the exercise group will be asked to follow a previously designed controlled exercise program (the exercises included a specific table with a flex-band for 1-month after AVF creation) and the control group will be asked not to perform specific exercises (following a usual lifestyle). Single-blind masking will be performed (specialists dedicated to this study will be blind to the results of randomization in all phases of the study; only the nurse instructing patients to follow the exercise program and the patients themselves will know the results of randomization).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Primary outcome is arteriovenous fistula maturation one month after fistula creation (yes/no, and % of arteriovenous fistula). It is measured by clinical and ultrasonographic methods:
1. Clinical maturation is defined, after physical examination by a dedicated nurse and medical specialists, as an easily palpable vein, with a straight-superficial segment, length more than 10 cm, sufficient diameter and good palpable thrill.
2. Ultrasonographic maturation is defined, after ultrasound examination, as a draining vein diameter ≥ 5 mm, skin-vein distance ≤ 6 mm and brachial blood flow rate (BFR) ≥ 500 mL/min.

Secondary outcome measures

N/A

Overall trial start date

01/11/2012

Overall trial end date

30/11/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All patients with chronic kidney diseases stages 5 (pre-dialysis) and 5D (hemodialysis) who visited in our center and are candidates for the creation of native AVF (arteriovenous fistula) in the upper extremity are invited to participate in this study. The inclusion criteria consisted of:
1. Ambulatory status
2. The ability to understand and perform the exercise program and attend a follow-up visit
3. Acceptance to participate
4. Provision of signed informed consent after receiving full information on the program

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

82 patients (41 per group) will be needed.

Participant exclusion criteria

1. Patients with previous dysfunctioning AVF in the same arm (AVF repairs)
2. Prosthetic accesses
3. Known arterial or venous diseases in the same arm

Recruitment start date

01/06/2013

Recruitment end date

30/11/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clinic
C\ Villarroel, 170
Barcelona
08036
Spain

Sponsor information

Organisation

Hospital Clinic

Sponsor details

C\ Villarroel 170
Barcelona
08036
Spain
932275400
gasparmestres@gmail.com

Sponsor type

Hospital/treatment centre

Website

www.hospitalclinic.org

Funders

Funder type