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Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)

NCT06572826 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-10-29

No results posted yet for this study

Summary

This is a prospective and retrospective multicentre study conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health (PNRR-MCNT2-2023-12377767). Using the Altshock registry, the largest multicentre Cardiogenic Shock (CS) registry in Italy, which currently has registered more than 1,000 CS patients across Italy, we will recruit patients to: (1) provide a granular assessment of post-acute phase programmes, patients' functional disability, return to work and quality of life, including specific reference to gender; (2) implement specific pathways of care in the post-acute phase; (3) provide a multidimensional assessment, thus validating an innovative model in comparison with the traditional pathway, defining the potential benefits to and impact on economic efficiency and the general sustainability of this therapeutic trajectory.

Conditions

  • Cardiogenic Shock

Interventions

OTHER

Cardiac Rehabilitation intervention

The cardiac rehabilitation program for post-CS patients includes respiratory physiotherapy, muscle strengthening and endurance training such as walking, treadmill exercises, and cycling, all tailored to the patient's capabilities. Cardiovascular training involves interval and continuous aerobic exercises to improve heart function. The program emphasizes secondary prevention strategies, including lifestyle changes and medication management. Neuromotor rehabilitation addresses sarcopenia and polyneuropathies through targeted exercises like balance training, gait retraining, and the use of advanced technologies like functional electrical stimulation (FES), robotic devices, and virtual/augmented reality. Cognitive-behavioral therapy (CBT) helps manage the psychological effects of severe cardiovascular events. The program also includes speech and occupational therapy, planning for home reintegration, and telerehabilitation to ensure long-term recovery.

Sponsors & Collaborators

  • Ospedale Civile Ss. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

    collaborator UNKNOWN

  • Azienda Ospedaliera Brotzu

    collaborator OTHER

  • Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

    collaborator OTHER

  • ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy

    collaborator UNKNOWN

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-03-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572826 on ClinicalTrials.gov