💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Tele-rehabilitation
- Standard of Care
Fondazione Don Carlo Gnocchi ETS
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky