No registrations found.
ID
Source
Brief title
Health condition
hemodialysis acces, AVF, maturation failure, nonmaturation, exercise, vein diameter
hemodialyse, toegangschirurgie, AVF, maturatie falen, nonmaturatie, training, vene diameter
Sponsors and support
Lijnbaan 32
2512VA Den Haag
Intervention
Outcome measures
Primary outcome
To investigate whether supervised, monitored forearm exercise increases blood
vessel size at pre-specified locations in the forearm of target vessels for AVF
surgery in ESRD patients.
Secondary outcome
To investigate whether supervised, monitored forearm exercise leads to a
change in surgical AVF site, using pre-specified criteria for the surgical plans.
- To investigate whether supervised, monitored forearm exercise increases AVF
maturation rate, with maturation being a diameter of 6mm and a flow of
600m1/min
- To investigate whether response to supervised, monitored forearm exercise on
top of absolute diameter, predicts AVF maturation
Background summary
Background: Failure of maturation occurs in 30-50% of creation of AV fistulas for hemodialysis, with highest rates in distal radiocephalic fistulas. This can partially be attributed to initial small blood vessel size with limited blood flow capacity. Forearm exercise has shown potential as stimulus for increasing blood vessel size in patients with end-stage renal disease (ESRD) and may promote maturation of AVFs in the upper limb when applied postoperatively. However, it is presently unknown if forearm exercise increases blood vessel size pre-operatively, which may facilitate more distal AVF creation, and might raise success rates of AVF surgery. This study will investigate these issues.
Methods and results: The PINCH trial is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with 1:1 randomization to perform supervised fore-arm exercises, or no exercise 6 weeks pre-operatively before creation of an AVF. 40 patients receiving an AVF will be included. The main study parameters/endpoints are blood vessel diameter (cephalic or basilic vein and radial and ulnar artery), AVF surgical plan (radiocephalic or brachiobasilic/-cephalic), and three-month (assisted) maturation rate. The burden of the performed fore-arm exercises will be evaluated using Quality of life (KDQOL-SF Dutch version 1.2 ) and exercise specific questionnaires. The PINCH trial will start in June 2017. Enrolment is expected to be completed after two years.
Conclusions: The PINCH study is the first trial to evaluate the effect of pre-operative, supervised forearm exercises on vein diameter and fistula maturation in hemodialysis patients
Study objective
pre-operative, supervised forearm exercises have a positive influence on vein diameter and therefore might improve fistula maturation in hemodialysis patients
Study design
finalisation handgrip trainer coupled e-device may 2017
first inclusion: june 2017
ending enrollment: 2019
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 traìner. 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.
E.D. Wilschut
postbus 432
Den Haag 2501 CK
The Netherlands
d.wilschut@haaglandenmc.nl
E.D. Wilschut
postbus 432
Den Haag 2501 CK
The Netherlands
d.wilschut@haaglandenmc.nl
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 parlicipation 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
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6226 |
| NTR-old | NTR6382 |
| CCMO | NL59337.098.16 |
| OMON | NL-OMON50205 |