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

Completed

• Conditions: Heart Arrest, Out-Of-Hospital; Physical Activity
• Interventions: Diagnostic Test: Measures of physical activity and kinesiophobia

• Registration Number: NCT03543332
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-01
• Study Start: 2018-07-21
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac arrest	Measures of physical activity and kinesiophobia	-
Myocardial infarction	Measures of physical activity and kinesiophobia	Myocardial infarction without cardiac arrest

Primary Outcome Measures

Name	Time	Method
Physical activity level	7 months after cardiac arrest	Questions about physical activity and physical training (patient reported), accelerometer, performance measure

Secondary Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (8)

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Salgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Halmstad Hospital; 🇸🇪 Halmstad, Sweden

Skane University Hospital Lund; 🇸🇪 Lund, Sweden

Hans Kirkegaard; 🇩🇰 Aarhus, Denmark

Skane University hospital; 🇸🇪 Malmö, Sweden

Thomas Keeble; 🇬🇧 Basildon, Essex, United Kingdom

Mattthew P Wise; 🇬🇧 Cardiff, United Kingdom