NCT05173740

Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiac Arrest
• Heart Arrest
• Cardiopulmonary Resuscitation
• Return to Work
• Return-to-work
• Rehabilitation
• Recovery of Function
• Cardiac Rehabilitation

Interventions

Type	Name	Description
OTHER	Individually tailored rehabilitation intervention	Individually tailored rehabilitation intervention
OTHER	Usual care	Usual care

Timeline

• Start date: 2022-02-01
• Primary completion: 2027-07-31
• Completion: 2028-07-31
• First posted: 2021-12-30
• Last updated: 2025-12-08

Locations

1 site across 1 country: Denmark