Home rehab program aims to keep heart patients out of hospital

NCT ID NCT07599306

Disease control Sponsor: Fondazione Don Carlo Gnocchi Onlus Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 4-month structured telerehabilitation program, delivered via video calls and an app, can reduce deaths and hospital readmissions in heart patients who have Post-Intensive Care Syndrome (PICS). About 326 adults aged 30-75 who were in the ICU for at least 48 hours will be randomly assigned to either the telerehab program plus standard care, or standard care alone. The program includes exercise sessions, psychological support, and nutritional counseling, all done from home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: telerehabilitation program (exercise, psychological support, nutritional counseling via video calls and app)
What this could lead to: If it works, this could offer a practical home-based rehab program to help heart patients recover more fully after intensive care and reduce their risk of returning to the hospital.
What could go wrong: This is a relatively small, early-stage trial (326 people) testing a complex program. The results may not apply to all patients, and the extra effort of telerehab might not provide clear benefits over standard care.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 326 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute quadriplegic myopathy Cognitive Dysfunction Critical Illness critical illness polyneuropathy heart disorder metabolic disease polyneuropathy postintensive care syndrome Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiopathy Critical illness Post-intensive care syndrome (PICS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Home rehab program aims to keep heart patients out of hospital

What the study statuses mean