Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03543332




Registration number
NCT03543332
Ethics application status
Date submitted
17/05/2018
Date registered
1/06/2018
Date last updated
16/09/2021

Titles & IDs
Public title
Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2
Scientific 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)
Secondary ID [1] 0 0
Cardiac Arrest Physical
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest, Out-Of-Hospital 0 0
Physical Activity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cardiac arrest -

Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2021
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niklas Nielsen, MD PhD
Address 0 0
Lund University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03543332