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The PINCH Study: Supervised preoperative forearm exercise to increase blood vessel diameter in patients that require an arteriovenous access for hemodialysis

The PINCH Study: Supervised preoperative forearm exercise to increase blood vessel diameter in patients that require an arteriovenous access for hemodialysis - The PINCH study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50205
Enrollment
48
Registered
2016-12-12
Start date
2017-12-14
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Blood vessel diameter Blood vessel size

Interventions

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 fre

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)