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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
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Measures of physical activity and kinesiophobia

Cardiac arrest -

Myocardial infarction - Myocardial infarction without cardiac arrest


Diagnosis / Prognosis: Measures of physical activity and kinesiophobia
Groups will be compared regarding kinesiophobia with TSK heart.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical activity level
Assessment method [1] 0 0
Questions about physical activity and physical training (patient reported), accelerometer, performance measure
Timepoint [1] 0 0
7 months after cardiac arrest
Secondary outcome [1] 0 0
Anxiety and Depression
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
7 months after cardiac arrest
Secondary outcome [2] 0 0
Lower extremity strength
Assessment method [2] 0 0
Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength
Timepoint [2] 0 0
6 months post arrest
Secondary outcome [3] 0 0
Cognitive impairment
Assessment method [3] 0 0
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
Timepoint [3] 0 0
6 months post arrest
Secondary outcome [4] 0 0
Kinesiophobia
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
7 months after cardiac arrest
Secondary outcome [5] 0 0
Cognitive impairment
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
6 months post arrest

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)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus
Country [2] 0 0
Sweden
State/province [2] 0 0
Göteborg
Country [3] 0 0
Sweden
State/province [3] 0 0
Halmstad
Country [4] 0 0
Sweden
State/province [4] 0 0
Helsingborg
Country [5] 0 0
Sweden
State/province [5] 0 0
Lund
Country [6] 0 0
Sweden
State/province [6] 0 0
Malmö
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Essex
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lund University
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Halmstad County Hospital
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sahlgrenska University Hospital
Country [3] 0 0

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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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