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Prehabilitation within patients with severe vascular disease of the legs

Effect of multimodal Prehabilitation On Chronic limb-threatening Ischemia (POCI-trial) - POCI-study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58069
Enrollment
300
Registered
2025-07-30
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

peripheral arterial disease, chronic limb-threatening ischemia severe vascular disease of the legs

Interventions

All patients undergo a general health screening by a vascular nurse practitioner (VNP) or researcher at the Multidisciplinary Vascular surgical outpatient clinic for the Elderly (MVE). Afterwards pati

Sponsors

Amphia Ziekenhuis
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged 65 years or olderDiagnosis of Chronic Limb Threatening Ischemia (CLTI), based on:Anamnestic complaints of ischemic rest pain or night pain (Rutherford stage 4) OR (Minor) tissue loss, non-healing ulcer and/or focal gangrene with diffuse pedal ischemia (Rutherford stage 5 and 6) (8)ANDImpaired perfusion, quantified by a flat or barely pulsatile ankle or metatarsal PVR (pulse volume recording), a low resting ankle pressure, a low ankle brachial index and/or a low toe pressure.Informal caregiver of an elderly patient (= 65 years) with CLTI

Exclusion criteria

Exclusion criteria: Need for urgent surgery or endovascular therapy (<2 weeks), based on either:WIfI-score of W = 3WIfI-score of fI = 3Inability to complete questionnaires, due to either lingual or cognitive incompetence. 

Design outcomes

Primary

MeasureTime frame
The primary outcome is the LOS.

Secondary

MeasureTime frame
Secondary outcomes will be QoL of the patient and their IC, 6-month mortality, hospital readmission rate, postoperative complications, level of perceived SDM and preferred participation in SDM of the patient and their IC, perceived and preferred roles in decision making (DM) of the patient and their IC and cost-effectiveness. 

Countries

Netherlands

Contacts

Public ContactS Verbaan

Amphia Ziekenhuis

sverbaan@amphia.nl0765954246

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 31, 2026