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

Recruiting now · Not applicable

Conditions studied: Critical Illness, Post Intensive Care Syndrome (PICS), Cardiopathy

In brief

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.

Key facts

Study ID

NCT07599306

Run by

Fondazione Don Carlo Gnocchi ETS

People needed

326

Starts

2026-04-13

Expected to finish

2028-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 30-75 years
• Previous ICU admission ≥48 hours
• Presence of Post-Intensive Care Syndrome (PICS), defined as at least one of the following objectively assessed impairments at baseline (T0):
• 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
• Psychological impairment, defined as Patient Health Questionnaire-9 (PHQ-9) score ≥ 10
• Nutritional impairment, defined as the presence of malnutrion according to GLIM criteria, requiring at least one phenotypic criterion (non-volitional weight loss >5% within 6 months or >10% beyond 6 months; BMI <20 kg/m² if <70 years or <22 kg/m² if ≥70 years; reduced muscle mass) and at least one etiologic criterion (reduced food intake or assimilation for >1 week, or any acute/chronic inflammatory burden) and/or presence of sarcopenia assessed by calf circumference <31 cm and reduced muscle strength measured by handgrip strength
• Metabolic or bone metabolism disorder, defined as altered bone metabolism markers (Bone Turnover Markers outside reference range)
• Ability to provide written informed consent

You may not qualify if…

• 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)
• Pre-existing severe cognitive impairment or dementia, defined as:
• documented diagnosis in the medical record prior to ICU admission
• Any clinical condition limiting participation in the rehabilitation program, including: severe orthopedic, neurological, or functional limitations not related to PICS

Where it is running

• Fondazione Don Carlo Gnocchi ETS — Milan, Milano, Italy (enrolling)

Full record on ClinicalTrials.gov

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