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.
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
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)
Parallel
Tele-rehabilitation
Other interventionA 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)
Standard of Care
Other interventionRoutine clinical care and standard rehabilitative treatment according to current hospital practices.
The Cumulative incidence of all-cause mortality and all-cause rehospitalization
This is a composite outcome measure defined as the cumulative incidence of the first occurrence of either death from any cause or hospital readmission for any cause.
The cumulative incidence of Major Adverse Cardiovascular Events
MACE is defined as a composite endpoint consisting of the first occurrence of any of the following: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Change in six minute walk test
The 6MWT assesses sub-maximal functional exercise capacity. It measures the distance a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The distance is measured in meters. Higher values represent better functional mobility and endurance. The change is calculated as the 4 months distance minus the baseline distance and the 12 months distance minus the baseline distance.
Change in Total Body Mass
Total body mass (weight) is measured in kilograms (kg) using a calibrated digital scale. The change is calculated as the body mass at 4 months of follow-up minus the body mass at baseline and the body mass at 12 months of follow-up minus the body mass at baseline.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The KCCQ is a 23-item, self-administered instrument that quantifies physical limitations, symptoms, social limitations, and quality of life in patients with heart failure. The domains are combined into an Overall Summary Score. Scores are transformed to a range from 0 to 100. Higher scores represent a better health-related quality of life and fewer symptoms. The change is calculated as the score at 4 months of follow-up minus the score at baseline and as the score at 12 months of follow-up minus the score at baseline.
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