Skip to main content
OpenTrials
Completed

NCT Number: NCT03543332

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Arrest, Out-Of-Hospital Anxiety Disorders Behavior Cardiovascular Diseases Heart Arrest Heart Diseases Kinesiophobia Mental Disorders Motor Activity Out-of-Hospital Cardiac Arrest Phobic Disorders Physical Activity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hans Kirkegaard, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measures of physical activity and kinesiophobia

Diagnostic Test

Groups will be compared regarding kinesiophobia with TSK heart.

Primary outcomes

  1. Physical activity level

    Time frame: 7 months after cardiac arrest

    Questions about physical activity and physical training (patient reported), accelerometer, performance measure

Secondary outcomes

  1. Anxiety and Depression

    Time frame: 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.

  2. Lower extremity strength

    Time frame: 6 months post arrest

    Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength

  3. Cognitive impairment

    Time frame: 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

  4. Kinesiophobia

    Time frame: 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.

  5. Cognitive impairment

    Time frame: 6 months post arrest

    The Montreal Cognitive Assessment (MoCA). It contains 11 sub-tests of several cognitive domains as executive functioning, short-term memory and delayed recall combined into a total maximum score of 30. A score ≥26 points is considered within the normal range, 25-18 indicate mild impairment, 17-10 indicate moderate impairment, and less than 10 indicate severe cognitive impairment.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Halmstad County Hospital
  • Lund University
  • Sahlgrenska University Hospital

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2018
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.