Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS) (CARDIO-PICS)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Anastasia Toccafondi, physioterapist
- Telefonnummer: 02-40308570
- E-post: atoccafondi@dongnocchi.it
Studiesteder
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Milano
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Milan, Milano, Italia, 20148
- Rekruttering
- Fondazione Don Carlo Gnocchi ETS
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Ta kontakt med:
- Anastasia Toccafondi, BcS
- Telefonnummer: 02 403081
- E-post: atoccafondi@dongnocchi.it
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Tele-rehabilitation group
Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach.
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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) |
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Aktiv komparator: Standard Care Group
Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines.
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Routine clinical care and standard rehabilitative treatment according to current hospital practices.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Cumulative incidence of all-cause mortality and all-cause rehospitalization
Tidsramme: From enrollment to 12 months
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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.
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From enrollment to 12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in six minute walk test
Tidsramme: Baseline, 4 months of follow-up, 12 months of follow-up
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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.
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Baseline, 4 months of follow-up, 12 months of follow-up
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Change in Total Body Mass
Tidsramme: Baseline, 4 months of follow-up, 12 months of follow-up
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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.
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Baseline, 4 months of follow-up, 12 months of follow-up
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Tidsramme: 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.
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Baseline, 4 months of follow-up, 12 months of follow-up.
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Change in Urinary Calcium to Creatinine Ratio (24-hour collection)
Tidsramme: 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.
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Baseline (0 months), 4 months, and 12 months
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Change in 24-Hour Creatinine Clearance
Tidsramme: Baseline, 4 months, and 12 months.
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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.
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Baseline, 4 months, and 12 months.
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Change in Serum Osteocalcin Levels
Tidsramme: Baseline, 4 months, and 12 months.
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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.
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Baseline, 4 months, and 12 months.
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Change in Intact Parathyroid Hormone (PTH) Levels
Tidsramme: 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.
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Baseline, 4 months, and 12 months.
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Change in Serum C-terminal Telopeptide of Type I Collagen (CTX)
Tidsramme: Baseline, 4 months, and 12 months.
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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.
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Baseline, 4 months, and 12 months.
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Change in Thyroid-Stimulating Hormone (TSH) Levels
Tidsramme: Baseline, 4 months, and 12 months.
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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.
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Baseline, 4 months, and 12 months.
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Change in Bone-Specific Alkaline Phosphatase (BsALP)
Tidsramme: Baseline, 4 months, and 12 months.
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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.
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Baseline, 4 months, and 12 months.
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The cumulative incidence of Major Adverse Cardiovascular Events
Tidsramme: From enrollment to 6 and 12 months
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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.
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From enrollment to 6 and 12 months
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
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Andre studie-ID-numre
- Cardio-PICS
- Post-critical and Heart (Annen identifikator: Fondazione Don Gnocchi ETS)
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