Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

Last updated: April 2, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

4

Condition

Circulation Disorders

Heart Attack (Myocardial Infarction)

Heart Failure

Treatment

Usual care

Individually tailored rehabilitation intervention

Clinical Study ID

NCT05173740
H-20049654
  • Ages 18-65
  • All Genders

Study Summary

This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA.

Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • All adult survivors with first time out-of-hospital cardiac arrest

  • Discharged from the Hospitals will be assessed eligible for inclusion

Exclusion

Exclusion criteria:

  • Survivors who prior to the cardiac arrest were not part of the labour force with atleast two years until they are qualified to receive retirement state pensions

  • Patients that cannot understand and fulfil the study surveys (in Danish)

  • Patients with short witnessed cardiac arrests with return of spontaneous circulationestimated less than 4 minutes and immediate awakening without ICU treatment

Study Design

Total Participants: 214
Treatment Group(s): 2
Primary Treatment: Usual care
Phase: 4
Study Start date:
February 01, 2022
Estimated Completion Date:
July 31, 2028

Study Description

The ROCK trial is a two-arm multicentre investigator-initiated clinical randomised controlled superiority trial evaluating the effectiveness of a comprehensive individually tailored rehabilitation intervention focusing on supporting labour marked participation of survivors of out-of-hospital cardiac arrest compared to usual care, with primary endpoint measured after 12 months follow-up.

The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. The investigators hypothesize that the intervention will result in a higher-level labour marked attachment one year after hospital discharge in addition to increased health-related quality of life.

A full statistical analysis plan describing all details have been developed. In short, data from the national register on social transfer payments (DREAM database) will form the basis for the primary outcome. The primary outcome is labour market participation, defined as the proportion of employment vs. on social transfer payment, and the primary end point will be collected 12 months after hospital discharge.

Connect with a study center

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.