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

Summary

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

Inclusion Criteria:

* 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

Exclusion Criteria

* 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

Conditions4

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