Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patien… (NCT07599306) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
Italy326 participantsStarted 2026-04-13
Plain-language 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.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-exi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing a tele-rehabilitation program delivered remotely for cardiac patients who've had a serious illness requiring intensive care, am I the right kind of patient for this — and does my specific heart condition and ICU history match what they're looking for?
2The trial is measuring deaths and hospital readmissions as its main outcomes, which are serious events — what does that tell us about how significant my current risk level is, and how might joining or not joining this program affect that risk in my situation?
3Because this is a non-drug, non-surgical study with no assigned phase, the evidence on how well this tele-rehab approach works is still being built — given that, would you recommend I consider this trial over or alongside standard in-person cardiac rehabilitation?
4Tele-rehabilitation means I'd likely be doing sessions from home using some kind of technology — is that realistic for me given my current physical condition after intensive care, and do I have the equipment and support at home to participate safely?
5If I join this trial and my condition worsens or I'm rehospitalized during the study, what happens to my participation — and would being in the trial delay or limit my access to other treatments you might want to try?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Cumulative incidence of all-cause mortality and all-cause rehospitalization