NCT03543332

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 21, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

May 17, 2018

Last Update Submit

September 15, 2021

Conditions

Heart Arrest, Out-Of-HospitalPhysical Activity

Keywords

Physical trainingKinesiophobia

Outcome Measures

Primary Outcomes (1)

  • Physical activity level

    Questions about physical activity and physical training (patient reported), accelerometer, performance measure

    7 months after cardiac arrest

Secondary Outcomes (5)

  • 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

Study Arms (2)

Cardiac arrest

Diagnostic Test: Measures of physical activity and kinesiophobia

Myocardial infarction

Myocardial infarction without cardiac arrest

Diagnostic Test: Measures of physical activity and kinesiophobia

Interventions

Measures of physical activity and kinesiophobiaDIAGNOSTIC_TEST

Groups will be compared regarding kinesiophobia with TSK heart.

Cardiac arrestMyocardial infarction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hans Kirkegaard

Aarhus, Denmark

Location

Salgrenska University Hospital

Gothenburg, Sweden

Location

Halmstad Hospital

Halmstad, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Skane University Hospital Lund

Lund, Sweden

Location

Skane University hospital

Malmo, Sweden

Location

Thomas Keeble

Basildon, Essex, United Kingdom

Location

Mattthew P Wise

Cardiff, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 39999023DERIVED

  • 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.

    PMID: 34223342DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestMotor ActivityKinesiophobia

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesBehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Niklas Nielsen, MD PhD

    Lund University

    PRINCIPAL INVESTIGATOR

  • Gisela Lilja, OT PhD

    Lund University

    STUDY DIRECTOR

  • Tobias Cronberg, PhD MD

    Lund University

    STUDY DIRECTOR

  • Åsa B Tornberg, RPT PhD

    Lund University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 1, 2018

Study Start

July 21, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

SE(5)DK(1)GB(2)