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

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)

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Heart Arrest, Out-Of-Hospital
• Intervention / Treatment: Diagnostic test: Measures of physical activity and kinesiophobia

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Hans Kirkegaard
• Sweden
  • Göteborg, Sweden
    • Salgrenska University hospital
  • Halmstad, Sweden
    • Halmstad Hospital
  • Helsingborg, Sweden
    • Helsingborg Hospital
  • Lund, Sweden
    • Skane University Hospital Lund
  • Malmö, Sweden
    • Skåne University Hospital
• United Kingdom
  • Cardiff, United Kingdom
    • Mattthew P Wise
  • Essex
    • Basildon, Essex, United Kingdom
      • Thomas Keeble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac arrest	Diagnostic test: Measures of physical activity and kinesiophobia; Groups will be compared regarding kinesiophobia with TSK heart.
Myocardial infarction; Myocardial infarction without cardiac arrest	Diagnostic test: Measures of physical activity and kinesiophobia; Groups will be compared regarding kinesiophobia with TSK heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Questions about physical activity and physical training (patient reported), accelerometer, performance measure	7 months after cardiac arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and Depression	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.	7 months after cardiac arrest
Lower extremity strength	Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength	6 months post arrest
Cognitive impairment	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	6 months post arrest
Kinesiophobia	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.	7 months after cardiac arrest
Cognitive impairment	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.	6 months post arrest

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Sahlgrenska University Hospital, Sweden; Halmstad County Hospital
• Investigators: Principal Investigator: Niklas Nielsen, MD PhD, Lund University; Study Director: Gisela Lilja, OT PhD, Lund University; Study Director: Tobias Cronberg, PhD MD, Lund University; Study Director: Åsa B Tornberg, RPT PhD, Lund University

Publications and helpful links

General Publications

• Heimburg K, Lilja G, Tornberg ÅB, Ullén S, Blennow Nordström E, Friberg H, Nielsen N, Østergaard LG, Grejs AM, Hill H, Keeble TR, Kirkegaard H, Mion M, Rylander C, Segerström M, Undén 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2018
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Kinesiophobia; Physical training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: Cardiac Arrest Physical

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No