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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 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

326

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Itália
    • Milano
      • Milan, Milano, Itália, 20148
        • Recrutamento
        • Fondazione Don Carlo Gnocchi ETS
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Tele-rehabilitation group
Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach.
Outro: 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)
Comparador Ativo: Standard Care Group
Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines.
Outro: Standard of Care
Routine clinical care and standard rehabilitative treatment according to current hospital practices.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Cumulative incidence of all-cause mortality and all-cause rehospitalization
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in six minute walk test
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fondazione Don Carlo Gnocchi Onlus

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de abril de 2026

Conclusão Primária (Estimado)

31 de outubro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

13 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de maio de 2026

Primeira postagem (Real)

20 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Cardio-PICS
  • Post-critical and Heart (Outro identificador: Fondazione Don Gnocchi ETS)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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