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

3 czerwca 2026 zaktualizowane przez: Anastasia Toccafondi, Fondazione Don Carlo Gnocchi Onlus

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.

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

326

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Włochy
    • Milano
      • Milan, Milano, Włochy, 20148
        • Rekrutacyjny
        • Fondazione Don Carlo Gnocchi ETS
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Tele-rehabilitation group
Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach.
Inny: 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 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)
Aktywny komparator: Standard Care Group
Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines.
Inny: Standard of Care
Routine clinical care and standard rehabilitative treatment according to current hospital practices.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The Cumulative incidence of all-cause mortality and all-cause rehospitalization
Ramy czasowe: From enrollment to 12 months
This is a composite outcome measure defined as the cumulative incidence of the first occurrence of either death from any cause or hospital readmission for any cause.
From enrollment to 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in six minute walk test
Ramy czasowe: Baseline, 4 months of follow-up, 12 months of follow-up
The 6MWT assesses sub-maximal functional exercise capacity. It measures the distance a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The distance is measured in meters. Higher values represent better functional mobility and endurance. The change is calculated as the 4 months distance minus the baseline distance and the 12 months distance minus the baseline distance.
Baseline, 4 months of follow-up, 12 months of follow-up
Change in Total Body Mass
Ramy czasowe: Baseline, 4 months of follow-up, 12 months of follow-up
Total body mass (weight) is measured in kilograms (kg) using a calibrated digital scale. The change is calculated as the body mass at 4 months of follow-up minus the body mass at baseline and the body mass at 12 months of follow-up minus the body mass at baseline.
Baseline, 4 months of follow-up, 12 months of follow-up
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Ramy czasowe: Baseline, 4 months of follow-up, 12 months of follow-up.
The KCCQ is a 23-item, self-administered instrument that quantifies physical limitations, symptoms, social limitations, and quality of life in patients with heart failure. The domains are combined into an Overall Summary Score. Scores are transformed to a range from 0 to 100. Higher scores represent a better health-related quality of life and fewer symptoms. The change is calculated as the score at 4 months of follow-up minus the score at baseline and as the score at 12 months of follow-up minus the score at baseline.
Baseline, 4 months of follow-up, 12 months of follow-up.
Change in Urinary Calcium to Creatinine Ratio (24-hour collection)
Ramy czasowe: Baseline (0 months), 4 months, and 12 months
This ratio evaluates calcium excretion normalized by creatinine levels in 24-hour urine collection to assess bone resorption and mineral metabolism. Measured in mg/mg (or mmol/mmol). The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline (0 months), 4 months, and 12 months
Change in 24-Hour Creatinine Clearance
Ramy czasowe: Baseline, 4 months, and 12 months.
A measure of glomerular filtration rate (GFR) calculated from 24-hour urine volume, urine creatinine, and serum creatinine levels to assess renal function. Measured in mL/min. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Serum Osteocalcin Levels
Ramy czasowe: Baseline, 4 months, and 12 months.
A biochemical marker of bone formation reflecting osteoblastic activity. Measured in ng/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Intact Parathyroid Hormone (PTH) Levels
Ramy czasowe: Baseline, 4 months, and 12 months.
A key regulator of calcium and phosphate metabolism. Measured in pg/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Serum C-terminal Telopeptide of Type I Collagen (CTX)
Ramy czasowe: Baseline, 4 months, and 12 months.
A specific marker of bone resorption reflecting osteoclast activity. Measured in ng/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Thyroid-Stimulating Hormone (TSH) Levels
Ramy czasowe: Baseline, 4 months, and 12 months.
Assessment of thyroid function, which can influence bone turnover rates. Measured in µIU/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Bone-Specific Alkaline Phosphatase (BsALP)
Ramy czasowe: Baseline, 4 months, and 12 months.
An isoenzyme of alkaline phosphatase that serves as a specific marker for bone formation and osteoblast activity. Measured in µg/L. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
The cumulative incidence of Major Adverse Cardiovascular Events
Ramy czasowe: From enrollment to 6 and 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 6 and 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 kwietnia 2026

Zakończenie podstawowe (Szacowany)

31 października 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

13 lutego 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Cardio-PICS
  • Post-critical and Heart (Inny identyfikator: Fondazione Don Gnocchi ETS)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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