Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS): Impact on Mortality, Rehospitalization, and Clinical-functional Outcomes.
Fondazione Don Carlo Gnocchi Onlus
326 participants
Apr 13, 2026
INTERVENTIONAL
Conditions
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 Criteria9
- 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 Criteria5
- 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
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Interventions
A structured, multidimensional telerehabilitation program delivered via the Maia Connected Care platform (AB Medica, MDR class IIa), lasting 16 weeks (4 months), in addition to standard post-rehabilitation care. 1. Synchronous sessions (televisits): Weeks 1-4: 2 sessions/week (physiotherapy + psychological support) Weeks 5-16: 1 session/week (alternating physiotherapy and psychological support) 1 session/month (nutritional counseling) 2. Asynchronous rehabilitation program (continuous for 16 weeks): Personalized exercise training (endurance and resistance training) delivered via video-guided modules; Remote monitoring and adaptation by clinicians 3. Cognitive training: Delivered via digital platform (RICORDO-DTx) Multidomain exercises tailored based on baseline MoCA performance 4\. Nutritional support: Monthly teleconsultations with a dietitian Monitoring using validated tools (MUST, SARC-F, BIA)
Routine clinical care and standard rehabilitative treatment according to current hospital practices.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07599306