Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

This two-arm, parallel-group randomized clinical trial investigates the effectiveness of an additional telerehabilitation program compared with standard care in patients with Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase is crucial for consolidating recovery and ensuring continuity of care, with telerehabilitation offering a promising tool to enhance long-term adherence and outcomes.

The primary objective is to evaluate whether a structured, multidisciplinary remote rehabilitation program can reduce the risk of rehospitalization and mortality while improving clinical, functional, and psychosocial recovery. Approximately 326 patients aged 30-75 years will be enrolled after inpatient rehabilitation and randomly assigned to either a four-month structured telerehabilitation program or standard post-discharge follow-up.

All participants will undergo assessments at 4 and 12 months to monitor physical, cognitive, psychological, and metabolic recovery, with the ultimate aim of promoting a more complete and sustained rehabilitation after critical illness.

Eligibility criteria

Qualifiers

Adults aged 30-75 years

Previous ICU admission ≥48 hours

Neuromotor impairment, defined as Diagnosis of Critical Illness Myopathy (CIM) or Critical Illness Polyneuropathy (CIP), confirmed by electromyography (EMG)

Cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score < 26

Disqualifiers

Prognostically unfavorable malnutrition defined as: CONUT score ≥5.

Delirium present at the time of the enrollment, documented by a positive Confusion Assessment Method (CAM or CAM-ICU)

Trial design

Treatments tested in this trial

  • Tele-rehabilitation
  • Standard of Care

Treatment groups

326 Participants
are divided into 2 treatment groups