RecruitingNot ApplicableNCT07599306

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.


Sponsor

Fondazione Don Carlo Gnocchi ETS

Enrollment

326 participants

Start Date

Apr 13, 2026

Study Type

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

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of Care and Tele-rehabilitation for people with cardiopathy, critical illness, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTele-rehabilitation

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)

OTHERStandard of Care

Routine clinical care and standard rehabilitative treatment according to current hospital practices.


Locations(1)

Fondazione Don Carlo Gnocchi ETS

Milan, Milano, Italy

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NCT07599306


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