Heart Arrest, Out-Of-Hospital, Physical Activity
Conditions
Keywords
Physical training, Kinesiophobia
Brief 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.
Interventions
Groups will be compared regarding kinesiophobia with TSK heart.
Sponsors
Study design
Eligibility
Inclusion criteria
* The TTM2 main trial includes adult, unconscious patients with sustained return of spontaneous circulation after cardiac arrest of a presumed cardiac origin. The aim is to include 100-150 OHCA-survivors to the sub-study.
Exclusion criteria
* An exclusion criterion for the TTM2 main trial is an unwitnessed cardiac arrest with initial rhythm asystole, temperature at admission \<30°C, on extracorporeal membrane oxygenation (ECMO) prior to return of spontaneous circulation (ROSC), obvious or suspected pregnancy, intracranial bleeding and/or severe chronic obstructive pulmonary disease (COPD) on home oxygen. An additional exclusion criterion for the sub-study is the inability to speak the local language well enough to complete the test without an interpreter. Patients with major cognitive impairment, patients sitting in a wheel chair, Clinical Frailty Score 8 or 9 (very severely frail or terminally ill), active drug abuse and when a face-to face follow-up is not possible will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity level | 7 months after cardiac arrest | Questions about physical activity and physical training (patient reported), accelerometer, performance measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and Depression | 7 months after cardiac arrest | Hospital Anxiety and Depression scale HADS is a self-reported questionnaire with seven questions related to anxiety and seven questions related to depression. Each item on the questionnaire is scored from 0-3. A total sum is calculated for each subscale and the total score range between zero and 21. |
| Lower extremity strength | 6 months post arrest | Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength |
| Cognitive impairment | 6 months post arrest | The Symbol Digit Modalities Test (SDMT) The total amount of correct answers within 90 seconds are calculated. There are normative scores and depending on age and education level |
| Kinesiophobia | 7 months after cardiac arrest | Tampa Scale for Kinesiophobia Heart, questionnaire TSK-SV Heart includes17 statements/questions summed into a total score that range from17 to 68. The higher the value, the greater degree of kinsiophobia. Values \>37 is considered as a high level of kinesiophobia. |
Countries
Denmark, Sweden, United Kingdom