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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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Cardiac Arrest Physical
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Arrest, Out-Of-Hospital
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Physical Activity
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Physical activity level
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Assessment method [1]
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Questions about physical activity and physical training (patient reported), accelerometer, performance measure
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Timepoint [1]
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7 months after cardiac arrest
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Secondary outcome [1]
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Anxiety and Depression
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Assessment method [1]
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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.
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Timepoint [1]
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7 months after cardiac arrest
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Secondary outcome [2]
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Lower extremity strength
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Assessment method [2]
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Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength
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Timepoint [2]
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6 months post arrest
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Secondary outcome [3]
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Cognitive impairment
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Assessment method [3]
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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
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Timepoint [3]
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6 months post arrest
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Secondary outcome [4]
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Kinesiophobia
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Assessment method [4]
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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.
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Timepoint [4]
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7 months after cardiac arrest
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Secondary outcome [5]
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Cognitive impairment
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Assessment method [5]
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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.
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Timepoint [5]
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6 months post arrest
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/02/2021
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Sample size
Target
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Accrual to date
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Final
109
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Aarhus
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Country [2]
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Sweden
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State/province [2]
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Göteborg
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Country [3]
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Sweden
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State/province [3]
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Halmstad
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Country [4]
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Sweden
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State/province [4]
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Helsingborg
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Country [5]
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Sweden
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State/province [5]
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Lund
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Country [6]
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Sweden
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State/province [6]
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Malmö
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Country [7]
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United Kingdom
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State/province [7]
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Essex
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Country [8]
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United Kingdom
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State/province [8]
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Cardiff
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Funding & Sponsors
Primary sponsor type
Other
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Name
Region Skane
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Lund University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Halmstad County Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Sahlgrenska University Hospital, Sweden
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03543332
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Niklas Nielsen, MD PhD
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Address
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Lund University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03543332
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