Structured telerehabilitation for cardiac patients after ICU care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-arm randomized trial compares a structured telerehabilitation program delivered remotely to standard post-discharge care in adults with Post-Intensive Care Syndrome following ICU hospitalization. It aims to reduce rehospitalization and mortality while improving clinical, functional, and psychosocial outcomes across multiple domains. Participants are 30–75 years old and have completed inpatient rehabilitation, then are randomized to four months of multidisciplinary telerehabilitation or usual follow-up, with assessments at 4 and 12 months. The intervention leverages remote, multicomponent rehabilitation to support adherence and continuity of care after discharge.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Don Carlo Gnocchi ETS
  Milan, Milano, Italy Recruiting

Study contacts

• Study coordinator: Anastasia Toccafondi, physioterapist
• Email: atoccafondi@dongnocchi.it
• Phone: 02-40308570

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Virtual reality to help recovery after intensive care (PICS)

  This study will try whether immersive virtual-reality brain-training helps adults recovering from ICU-related memory and thinking problems improve more than the same games on a tablet or usual care.

  Recruiting University of Minho · Porto, Porto District · NCT07585500

• PROTECT-ICU: Training ICU staff to reduce post-ICU health problems

  This trial will test whether training ICU staff to use a standard or expanded care bundle helps adults who spend at least 48 hours in the ICU have fewer physical, thinking, or emotional problems three months after hospital discharge.

  Recruiting Spanish Society of Critical Care Medicine and Coronary Units · Orihuela, Alicante and 1 other locations · NCT07542613

• Predicting Extubation Problems With Machine Learning

  This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

  Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

• Levetiracetam Dosing in Critically Ill on CRRT

  This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.

  Recruiting Chulalongkorn University · Pathum Wan, Bangkok · NCT07918833

• Respiratory Physiotherapy in Critically Ill Pneumonia Patients

  This study tests whether a structured breathing and chest therapy program can change inflammatory biomarkers in adults with pneumonia in the ICU compared to usual care.

  Recruiting Hospital H+ Queretaro · Querétaro · NCT07909616

• Immersive VR for improving upper limb function in critically ill ICU patients

  This trial tests whether fully immersive virtual reality training added to standard ICU rehabilitation can help improve upper limb strength and coordination in adults with ICU-acquired weakness.

  Recruiting National and Kapodistrian University of Athens · Athens, Attica · NCT07901855

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.