NCT07599306 Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
| NCT ID | NCT07599306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 326 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 326 participants in total. It began in 2026-04-13 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07599306 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07599306 currently recruiting?
Yes, NCT07599306 is actively recruiting participants. Contact the research team at atoccafondi@dongnocchi.it for enrollment information.
Where is the NCT07599306 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07599306 clinical trial?
NCT07599306 is sponsored by Fondazione Don Carlo Gnocchi Onlus. The trial plans to enroll 326 participants.