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

Official title

Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS): Impact on Mortality, Rehospitalization, and Clinical-functional Outcomes.

Overview

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.

Detailed description

This interventional, two-arm, parallel-group randomized clinical trial aims to evaluate the effectiveness of an additional rehabilitation intervention compared with standard clinical practice in patients affected by Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase represents a critical period for consolidating the therapeutic gains achieved during inpatient rehabilitation and reinforcing the clinical recommendations provided. In this framework, telerehabilitation emerges as a potentially valuable strategy to enhance adherence to post-rehabilitation prescriptions and ensure continuity of care.

The primary objective of the study is to assess whether a structured remote intervention can reduce the risk of rehospitalization and mortality, while improving clinical and functional outcomes across the four key domains of PICS. Specifically, the study will determine whether a multidisciplinary, remotely delivered cardiac telerehabilitation program can promote recovery and decrease the incidence of readmissions or complications among patients previously hospitalized in the Intensive Care Unit.

Following completion of the inpatient rehabilitation program, participants will be randomly allocated to one of two groups: the intervention group will undergo a structured four-month telerehabilitation program, whereas the control group will continue with standard discharge recommendations and conventional follow-up. All participants will be evaluated at 4 and 12 months after discharge to monitor physical, cognitive, psychological, and metabolic outcomes and to assess the long-term effectiveness of the intervention.

A total of approximately 326 patients aged between 30 and 75 years will be enrolled. Participation will be offered to individuals exhibiting signs or symptoms consistent with Post-Intensive Care Syndrome (PICS), with the overall aim of promoting a more complete and sustained recovery following the critical illness phase.

Interventions

• Other Tele-rehabilitation
  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 1
• Other Standard of Care
  Routine clinical care and standard rehabilitative treatment according to current hospital practices.

Primary outcome measures

• The Cumulative incidence of all-cause mortality and all-cause rehospitalization [Time frame: From enrollment to 12 months]

Secondary outcome measures (11)

• The cumulative incidence of Major Adverse Cardiovascular Events [Time frame: From enrollment to 6 and 12 months]
• Change in six minute walk test [Time frame: Baseline, 4 months of follow-up, 12 months of follow-up]
• Change in Total Body Mass [Time frame: Baseline, 4 months of follow-up, 12 months of follow-up]
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [Time frame: Baseline, 4 months of follow-up, 12 months of follow-up.]
• Change in Urinary Calcium to Creatinine Ratio (24-hour collection) [Time frame: Baseline (0 months), 4 months, and 12 months]
• Change in 24-Hour Creatinine Clearance [Time frame: Baseline, 4 months, and 12 months.]
• Change in Serum Osteocalcin Levels [Time frame: Baseline, 4 months, and 12 months.]
• Change in Intact Parathyroid Hormone (PTH) Levels [Time frame: Baseline, 4 months, and 12 months.]
• Change in Serum C-terminal Telopeptide of Type I Collagen (CTX) [Time frame: Baseline, 4 months, and 12 months.]
• Change in Thyroid-Stimulating Hormone (TSH) Levels [Time frame: Baseline, 4 months, and 12 months.]
• Change in Bone-Specific Alkaline Phosphatase (BsALP) [Time frame: Baseline, 4 months, and 12 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Italy · 1 center

• Fondazione Don Carlo Gnocchi ETS — Milan

Identifiers

NCT: NCT07599306 · Cardio-PICS · Post-critical and Heart

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗