NCT03543332

Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2

Physical Activity After Cardiac Arrest; Protocol of a Sub-study in the Targeted Hypothermia Versus Targeted Normothermia After Out-of-Hospital Cardiac Arrest Trial (TTM2)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

The Target Temperature Management trial 2 (TTM2) is an international multi-center study, that randomize patients with OHCA of a presumed cardiac or unknown cause to target temperature management at 33°C or normothermia but avoiding fever (37.8°C) for the first 24 hours after the OHCA. The TTM2 study (clinicaltrials.gov Identifier NCT02908308) includes a detailed follow-up of functional outcome, health-related quality of life and neurocognitive function at 6 and 24 months post-arrest. This protocol describes a sub-study within the TTM2 trial that specifically focus on physical activity among the OHCA survivors.

Detailed description

The primary aim of this study is to investigate whether OHCA-survivors have lower levels of self-reported physical activity compared to a non-cardiac arrest (CA) control group who had acute myocardial infarction (MI). Additional aims are to explore potential predictors of physical inactivity (older age, female gender, problems with general physical function, global cognition, mental processing speed/attention, anxiety symptoms, depression symptoms, kinesiophobia, fatigue), and to investigate the relationship between self-reported and objectively measured physical activity among OHCA-survivors.

Conditions

• Heart Arrest, Out-Of-Hospital
• Physical Activity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measures of physical activity and kinesiophobia	Groups will be compared regarding kinesiophobia with TSK heart.

Timeline

• Start date: 2018-07-21
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2018-06-01
• Last updated: 2021-09-16

Locations

8 sites across 3 countries: Denmark, Sweden, United Kingdom