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

NCT ID: NCT03543332

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-21
• Study Completion Date: 2021-02-28

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.

Conditions

Heart Arrest, Out-Of-Hospital; Physical Activity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac arrest

Measures of physical activity and kinesiophobia

Intervention Type: DIAGNOSTIC_TEST

Groups will be compared regarding kinesiophobia with TSK heart.

Myocardial infarction

Myocardial infarction without cardiac arrest

Measures of physical activity and kinesiophobia

Intervention Type: DIAGNOSTIC_TEST

Groups will be compared regarding kinesiophobia with TSK heart.

Interventions

Measures of physical activity and kinesiophobia

Groups will be compared regarding kinesiophobia with TSK heart.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Halmstad County Hospital

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niklas Nielsen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Gisela Lilja, OT PhD

Role: STUDY_DIRECTOR

Lund University

Tobias Cronberg, PhD MD

Role: STUDY_DIRECTOR

Lund University

Åsa B Tornberg, RPT PhD

Role: STUDY_DIRECTOR

Lund University

Locations

Hans Kirkegaard

Aarhus, , Denmark

Salgrenska University Hospital

Gothenburg, , Sweden

Halmstad Hospital

Halmstad, , Sweden

Helsingborg Hospital

Helsingborg, , Sweden

Skane University Hospital Lund

Lund, , Sweden

Skane University hospital

Malmo, , Sweden

Thomas Keeble

Basildon, Essex, United Kingdom

Mattthew P Wise

Cardiff, , United Kingdom

Countries

Denmark; Sweden; United Kingdom

References

Heimburg K, Nordstrom EB, Friberg H, Oestergaard LG, Grejs AM, Keeble TR, Kirkegaard H, Mion M, Nielsen N, Rylander C, Segerstrom M, Tornberg AB, Ullen S, Unden J, Wise MP, Cronberg T, Lilja G. Comparison of self-reported physical activity between survivors of out-of-hospital cardiac arrest and patients with myocardial infarction without cardiac arrest: a case-control study. Eur J Cardiovasc Nurs. 2025 Jul 21;24(5):700-709. doi: 10.1093/eurjcn/zvaf032.

Reference Type: DERIVED

PMID: 39999023 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34223342 (View on PubMed)

Other Identifiers

Cardiac Arrest Physical

Identifier Type: -

Identifier Source: org_study_id