Actively Recruiting

Age: 18Years - 110Years
All Genders
ID06572826

A Framework for an Integrated Assessment of Cardiac Rehabilitation Programs in Patients Acutely Managed for Cardiogenic Shock - ENIGMA-shock

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-10-29

2000

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

F

Fondazione Don Carlo Gnocchi Onlus

Lead Sponsor

O

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter study involving patients who have experienced Cardiogenic Shock (CS) to better understand post-acute care programs, patients' functional recovery, return to work, and quality of life. The study will also evaluate new care pathways compared with traditional methods to assess their impact on health outcomes, economic efficiency, and sustainability. This research is funded by the Italian Ministry of Health and coordinated by IRCCS Fondazione Don Gnocchi using data from the Altshock registry, the largest CS registry in Italy. The study focuses on cardiac rehabilitation interventions for CS survivors, including respiratory physiotherapy, muscle strengthening, endurance exercises like walking and cycling, and cardiovascular training. Neuromotor rehabilitation targets muscle loss and nerve damage with specialized exercises and technologies such as functional electrical stimulation, robotics, and virtual reality. Additional support includes cognitive-behavioral therapy for psychological effects, speech and occupational therapy, home reintegration planning, and telerehabilitation to support long-term recovery. Participants will be followed for up to one year after ICU discharge, with assessments at six months measuring survival rates, hospital readmissions, functional recovery, and patient-reported health status. Researchers will collect clinical, economic, and patient experience data to compare outcomes between those receiving post-acute care services and those who do not. The goal is to validate an innovative care model that improves quality of life and reduces mortality while demonstrating cost-effectiveness and healthcare sustainability.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All consecutive patients with a clinical diagnosis of Cardiogenic Shock
Not Eligible

You will not qualify if you...

  • Refusal to give informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 1 year

Participants who undergo routine care for cardiogenic shock are observed over time to assess survival, hospital readmissions, and functional recovery.

Follow-up visits at 6 months and 1 year

Surveillance

Duration - 6 months

Participants' functional recovery and patient-reported outcomes related to illness severity, disease-specific symptoms, and chronic conditions are assessed.

Assessments at 6 months including functional tests and questionnaires

Trial Site Locations

Total: 1 location

1

Fondazione Don Gnocchi

Milan, Italy, 20148

Actively Recruiting

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Research Team

N

Nuccia Morici, MD

P

Paolo Pedersini, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.

Stephan Mueller, Ephraim B Winzer, André Duvinage...

https://pubmed.ncbi.nlm.nih.gov/33560320

Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis.

Lindsey Anderson, Neil Oldridge, David R Thompson...

https://pubmed.ncbi.nlm.nih.gov/26764059

Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association.

Gary J Balady, Philip A Ades, Vera A Bittner...

https://pubmed.ncbi.nlm.nih.gov/22082676