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| ID | Type | Description | Link |
|---|---|---|---|
| Post-critical and Heart | Other Identifier | Fondazione Don Gnocchi ETS |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-rehabilitation group | Experimental | Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach. |
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| Standard Care Group | Active Comparator | Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative incidence of all-cause mortality and all-cause rehospitalization | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative incidence of Major Adverse Cardiovascular Events | 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 |
| Change in six minute walk test |
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Inclusion Criteria:
Ability to provide written informed consent
Exclusion Criteria
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Toccafondi, physioterapist | Contact | 02-40308570 | atoccafondi@dongnocchi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Don Carlo Gnocchi ETS | Recruiting | Milan | Milano | 20148 | Italy |
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Single-center, two-arm parallel randomized study
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| Standard of Care | Other | Routine clinical care and standard rehabilitative treatment according to current hospital practices. |
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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. |
| Baseline, 4 months of follow-up, 12 months of follow-up |
| Change in Total Body Mass | 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 | 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) | 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 | 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 | 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 | 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) | 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 | 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) | 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. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| C000657744 | postintensive care syndrome |
| D006331 | Heart Diseases |
| D011115 | Polyneuropathies |
| D055948 | Sarcopenia |
| D060825 | Cognitive Dysfunction |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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