To investigate whether pre-operative supervised forearm exercise increases blood vessel size and success rates of AVF surgery in end stage renal disease patients.
ID
Source
Brief title
Condition
- Nephropathies
- Vascular therapeutic procedures
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Per-patient change in cephalic vein or radial artery diameter after six weeks
of forearm exercise, as assessed by duplex ultrasound at pre-specified
locations in the forearm.
Secondary outcome
- Change in operative plan i.e. when the initial plan of brachiocephalic
fistula creation is changed into radiocephalic fistula creation following six
weeks of forearm exercise. Minimal cephalic vein diameter at the wrist must be
2.0mm in order to proceed for a radiocephalic fistula.
- Cephalic vein diameter end flow six weeks after the operation, as assessed by
duplex ultrasound.
- Per-patient change of cephalic or basilic vein diameter from the operation
until six weeks postoperatively.
- If applicable, shunt flow 6 and 12 weeks postoperatively
Background summary
The number of patients on hemodialysis worldwide is increasing. In the
Netherlands the incidence is 115:1 million. This means almost 2000 new
dialysispatients per year. A well functioning arterio-venous fistel (AVF) is
essential for succesfull dialysis en form vital importance for dialysis
patients.
A major problem in creating a AVF for dialysis purposes is the percentage of
non-maturation (30-50%). This means that he AVF does not reach an adequate flow
and diameter within 6 weeks after surgery. In this case frequent
re-interventions are necessary and it is often necessary to create a new AVF,
or patients are dependant on a synthetic graft or use of central venous
catheters, with all associated risks ( infection, trombosis, short patency).
All this results in delay in the dialysis traject en causes significant
morbidity.
The prefered site for creating an AVF is the wrist ( a radio-cephalic AVF) of
the non dominant arm, because the risk of ischemic complications for the hand
is smallest in this case. However, non-maturation is more frequent in
radio-cephalic AVF, correlating with a smaller diameter of blood vessels at
this location.
Small, non randomized studies suggest that performing postoperative forearm
exercises have a positive influence on the blood vessel diameter en therefore
promotes the process of maturation. Bases on these results, international
guidelines advise standard postoperative exercises after AFV surgery.
The significance of performing pre-operative pinch exercises has never been
investigated, while theoretically this would promote vessel diameter before
surgery and might make the operation technically easier and potentially
decreases the non maturation rate. Because it is known that the succes of
exercise therapy is correlating with the intensity of supervision and
standardisation of these exercises, an electronically (app-based) training
schedule, combined with structural physiotherapy can be of great importance.
Study objective
To investigate whether pre-operative supervised forearm exercise increases
blood vessel size and success rates of AVF surgery in end stage renal disease
patients.
Study design
Single blind randomized controlled trial
Intervention
Participants will receive a daily program of structured forearm exercises for
the arm that is planned for surgery. At home training program adherence is
stimulated and monitored for efficacy and frequency by validated e-devices
coupled to a handgrip trainer. Moreover, patients are expected to attend
focused physiotherapy group sessions once a week. After six weeks, an
additional Duplex ultrasound examination will be executed to compare blood
vessel diameters. After the operation, patients are followed up according to
regular protocol. The control group does not undergo forearm exercise prior to
AVF surgery, as is standard practice to date. During the study period, all
participants will be asked to fill in the e-questionnaires about quality of
life, burden of disease and (study) treatment, and forearm exercises apart from
the study protocol.
Study burden and risks
The burden is mainly due to physical fatigue during exercise. Moreover, there
are about 5 additional site visits for physiotherapy, as many as possible
planned on days that patients already have appointments in the outpatient
clinic for other reasons. There will be six e-questionnaire moments during the
exercise program. The risk of damage to the patient, besides temporary fatigue
is neligible.
Lijnbaan 32 32
Den Haag 2512 VA
NL
Lijnbaan 32 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
1. Patients who are scheduled for creation of an AVF for maintenance
haemodialysis.
2. Male or female * 18 years old.
3. Patients are able and willing to give written informed consent.
4. Patients are able to attend once weekly physiotherapy classes.
5. Patients have a cephalic vein diameter equalling at least 1mm.
Exclusion criteria
1. Any concurrent illness, disability or clinically significant abnormality
that may, as judged
by the investigator, affect the interpretation of clinical efficacy or safety
data or prevent
the subject from safely completing the assessments required by the protocol.
2. Current participation in another interventional clinical trial
3. Previous AVF in the ipsilateral arm
4. Patients who are unlikely to adequately comply with the trial*s procedures
(due for
instance to medical conditions likely to require an extended interruption or
discontinuation, history of substance abuse or noncompliance).
5. Patients with absent cephalic vein in the ipsilateral arm.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59337.098.16 |
| OMON | NL-OMON26121 |