Critical IllnessCARDIO-PICSNCT07599306
Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
A study testing Tele-rehabilitation in people with Critical Illness and Post Intensive Care Syndrome (PICS), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Critical Illness, Post Intensive Care Syndrome (PICS), Cardiopathy
- What is being tested?
- Tele-rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi ETS
Milan, Milano, 20148
Anastasia Toccafondi, BcS, 02 403081, atoccafondi@dongnocchi.it
About this study
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.
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.
Read the 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.
- Being tested
- Tele-rehabilitation, Standard of Care
- Keywords
- ICU, PICS, Multimodal rehabilitation, critical illness recovery, Polyneuropathies, Sarcopenia, Nutrition Assessment, Cognitive Dysfunction, Metabolic Diseases, tele-rehabilitation
- Medical subject headings
- Critical Illness, postintensive care syndrome, Heart Diseases, Polyneuropathies, Sarcopenia, Cognitive Dysfunction, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitationOther
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
- Nutritional support: Monthly teleconsultations with a dietitian Monitoring using validated tools (MUST, SARC-F, BIA)
Standard of CareOther
Routine clinical care and standard rehabilitative treatment according to current hospital practices.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation group | Experimental | Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 months
Secondary outcomes (11)
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.
Measured: From enrollment to 6 and 12 months
Change in six minute walk test
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 Apr 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, two-arm parallel randomized study
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Toccafondi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599306
- Sponsor's protocol ID
- Cardio-PICS
- Other IDs
- Post-critical and Heart
- Acronym
- CARDIO-PICS
- Status last verified
- May 2026
- First submitted
- 13 Feb 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07599306
- Acronym / sponsor ID
- CARDIO-PICS / Cardio-PICS
- Keywords
- ICU, PICS, Multimodal rehabilitation, critical illness recovery, Polyneuropathies, Sarcopenia, Nutrition Assessment, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, two-arm parallel randomized study
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation group | Experimental | Other: Tele-rehabilitationParticipants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach. |
| Standard Care Group | Active comparator | Other: Standard of CareParticipants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-rehabilitationA 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) | Other | Tele-rehabilitation group |
| Standard of CareRoutine clinical care and standard rehabilitative treatment according to current hospital practices. | Other | Standard Care Group |
Primary outcome
The Cumulative incidence of all-cause mortality and all-cause rehospitalization
Time frame: 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.
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation in people with Critical Illness and Post Intensive Care Syndrome (PICS), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Toccafondi, physioterapist (02-40308570, atoccafondi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cumulative incidence of all-cause mortality and all-cause rehospitalization (time frame: From enrollment to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.