Clinical trial NCT03543332: Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest, Out-Of-Hospital
Physical Activity
Keywords: Physical training
Kinesiophobia
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Halmstad County Hospital
name: Sahlgrenska University Hospital
First posted: 2018-06-01
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surviving patients in the TTM2-trial are invited to a structured face-to-face follow-up visit at 180 days (+/- 2 weeks). Survivors at selected sites will be invited to an extended study on physical activity at their follow-up visit.

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.

Eligibility 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.

Primary outcomes:
measure: Physical activity level
timeFrame: 7 months after cardiac arrest
Secondary outcomes:
measure: Anxiety and Depression
timeFrame: 7 months after cardiac arrest
measure: Lower extremity strength
timeFrame: 6 months post arrest
measure: Cognitive impairment
timeFrame: 6 months post arrest
measure: Kinesiophobia
timeFrame: 7 months after cardiac arrest
measure: Cognitive impairment
timeFrame: 6 months post arrest
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Hans Kirkegaard
city: Göteborg
country: Sweden
facility: Salgrenska University Hospital
city: Halmstad
country: Sweden
facility: Halmstad Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Lund
country: Sweden
facility: Skane University Hospital Lund
city: Malmö
country: Sweden
facility: Skane University hospital
city: Basildon
country: United Kingdom
facility: Thomas Keeble
state: Essex
city: Cardiff
country: United Kingdom
facility: Mattthew P Wise
Study officials:
affiliation: Lund University
name: Niklas Nielsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Gisela Lilja, OT PhD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Tobias Cronberg, PhD MD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Åsa B Tornberg, RPT PhD
role: STUDY_DIRECTOR
References:
citation: Heimburg K, Lilja G, Tornberg AB, Ullen S, Blennow Nordstrom E, Friberg H, Nielsen N, Ostergaard LG, Grejs AM, Hill H, Keeble TR, Kirkegaard H, Mion M, Rylander C, Segerstrom M, Unden J, Wise MP, Cronberg T. 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). Resusc Plus. 2021 Jan 29;5:100076. doi: 10.1016/j.resplu.2021.100076. eCollection 2021 Mar.