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

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

Sponsors

Lead sponsor: Region Skane

Collaborator: Lund University
Halmstad County Hospital
Sahlgrenska University Hospital, Sweden
Stockholm South General Hospital

Source 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

At this follow-up physical activity will be evaluated by self-reported questions based on the recommended levels from American College of Sports Medicine and the American Heart Association for physical activity and physical training for secondary prevention after myocardial infarction The first aim of this sub-study is to investigate the validity of two self-reported questions on physical activity. The second aim is to explore kinesiophobia among OHCA-survivors.

Overall Status Enrolling by invitation
Start Date July 21, 2018
Completion Date July 2021
Primary Completion Date July 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Physical activity level 7 months after cardiac arrest
Secondary Outcome
Measure Time Frame
Anxiety and Depression 7 months after cardiac arrest
Lower extremity strength 6 months post arrest
Cognitive impairment 6 months post arrest
Kinesiophobia 7 months after cardiac arrest
Cognitive impairment 6 months post arrest
Enrollment 200
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Measures of physical activity and kinesiophobia

Description: Groups will be compared regarding kinesiophobia with TSK heart.

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Overall Official
Location
facility
Hans Kirkegaard | Aarhus, Denmark
Salgrenska University Hospital | Göteborg, Sweden
Halmstad Hospital | Halmstad, Sweden
Helsingborg Hospital | Helsingborg, Sweden
Skane University Hospital Lund | Lund, Sweden
Skane University hospital | Malmö, Sweden
Thomas Keeble | Basildon, Essex, United Kingdom
Mattthew P Wise | Cardiff, United Kingdom
Location Countries

Denmark

Sweden

United Kingdom

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Cardiac arrest

Arm group label: Myocardial infarction

Description: Myocardial infarction without cardiac arrest

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov