Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)

NCT07599306 | Recruiting

• 2 other identifiers: Cardio-PICSPost-critical and Heart
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Post Intensive Care Syndrome (PICS); Cardiopathy

Keywords

ICU; PICS; Multimodal rehabilitation; critical illness recovery; Polyneuropathies; Sarcopenia; Nutrition Assessment; Cognitive Dysfunction; Metabolic Diseases; tele-rehabilitation

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence of Major Adverse Cardiovascular Events at 12 months

  MACE is defined as a composite endpoint consisting of the first occurrence of any of the following: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

  From enrollment to 12 months

Secondary Outcomes (10)

• Change in six minute walk test

  Baseline, 4 months of follow-up, 12 months of follow-up

• Change in Total Body Mass

  Baseline, 4 months of follow-up, 12 months of follow-up

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

  Baseline, 4 months of follow-up, 12 months of follow-up.

• Change in Urinary Calcium to Creatinine Ratio (24-hour collection)

  Baseline (0 months), 4 months, and 12 months

• Change in 24-Hour Creatinine Clearance

  Baseline, 4 months, and 12 months.

Study Arms (2)

Tele-rehabilitation group

EXPERIMENTAL

Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach.

Other: Tele-rehabilitation

Standard Care Group

ACTIVE COMPARATOR

Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines.

Other: Standard of Care

Interventions

Tele-rehabilitation OTHER

A structured, multidimensional telerehabilitation program delivered via the Maia Connected Care platform (AB Medica, MDR class IIa), lasting 16 weeks (4 months), in addition to standard post-rehabilitation care. 1. Synchronous sessions (televisits): Weeks 1-4: 2 sessions/week (physiotherapy + psychological support) Weeks 5-16: 1 session/week (alternating physiotherapy and psychological support) 1 session/month (nutritional counseling) 2. Asynchronous rehabilitation program (continuous for 16 weeks): Personalized exercise training (endurance and resistance training) delivered via video-guided modules; Remote monitoring and adaptation by clinicians 3. Cognitive training: Delivered via digital platform (RICORDO-DTx) Multidomain exercises tailored based on baseline MoCA performance 4\. Nutritional support: Monthly teleconsultations with a dietitian Monitoring using validated tools (MUST, SARC-F, BIA)

Tele-rehabilitation group

Standard of Care OTHER

Routine clinical care and standard rehabilitative treatment according to current hospital practices.

Standard Care Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi ETS

Milan, Milano, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome; Heart Diseases; Polyneuropathies; Sarcopenia; Cognitive Dysfunction; Metabolic Diseases

Interventions

Telerehabilitation; Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Anastasia Toccafondi, physioterapist

CONTACT

02-40308570; atoccafondi@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: Single-center, two-arm parallel randomized study

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: May 20, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

IT (1)