RecruitingNCT06572826

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

A framEwork for aN InteGrated assessMent of cArdiac Rehabilitation Programs in Patients Acutely Managed for Cardiogenic Shock - ENIGMA-shock

Sponsor

Fondazione Don Carlo Gnocchi ETS

Enrollment

2,000 participants

Start Date

Aug 31, 2024

Study Type

OBSERVATIONAL

Conditions

Cardiogenic Shock

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.

Eligibility

Min Age: 18 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cardiac Rehabilitation intervention for people with cardiogenic shock. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 110 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCardiac 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.