Heart Arrest, Out-Of-HospitalNCT03543332
Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2
An observational study of Heart Arrest, Out-Of-Hospital and Physical Activity, run by Region Skane at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Arrest, Out-Of-Hospital, Physical Activity
- What is being tested?
- Measures of physical activity and kinesiophobia
- How many people
- 109 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 21 Jul 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Sweden5 sites
Salgrenska University Hospital
Gothenburg
Halmstad Hospital
Halmstad
Helsingborg Hospital
Helsingborg
Skane University Hospital Lund
Lund
Skane University hospital
Malmö
United Kingdom2 sites
Thomas Keeble
Basildon, Essex
Mattthew P Wise
Cardiff
About this study
Official 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)
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.
Read the 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.
- Conditions
- Heart Arrest, Out-Of-Hospital, Physical Activity
- Being tested
- Measures of physical activity and kinesiophobia
- Keywords
- Physical training, Kinesiophobia
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of physical activity and kinesiophobiaDiagnostic test
Groups will be compared regarding kinesiophobia with TSK heart.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest | Not described Receives: Diagnostic Test: Measures of physical activity and kinesiophobia | |
| Myocardial infarction | Myocardial infarction without cardiac arrest Receives: Diagnostic Test: Measures of physical activity and kinesiophobia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Questions about physical activity and physical training (patient reported), accelerometer, performance measure
Measured: 7 months after cardiac arrest
Secondary outcomes (5)
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.
Measured: 7 months after cardiac arrest
Lower extremity strength
Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months post arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start21 Jul 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Halmstad County Hospital, Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Niklas Nielsen, MD PhD, Principal investigator, Lund UniversityGisela Lilja, OT PhD, Study director, Lund UniversityTobias Cronberg, PhD MD, Study director, Lund UniversityÅsa B Tornberg, RPT PhD, Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543332
- Sponsor's protocol ID
- Cardiac Arrest Physical
- Status last verified
- Sep 2021
- First submitted
- 17 May 2018
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39999023Heimburg 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.
PubMed 34223342
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03543332
- Acronym / sponsor ID
- Cardiac Arrest Physical
- Conditions
- Heart Arrest, Out-Of-Hospital, Physical Activity
- Keywords
- Physical training, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Halmstad County Hospital, Sahlgrenska University Hospital
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest | – | Diagnostic Test: Measures of physical activity and kinesiophobia |
| Myocardial infarction | – | Diagnostic Test: Measures of physical activity and kinesiophobiaMyocardial infarction without cardiac arrest |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measures of physical activity and kinesiophobiaGroups will be compared regarding kinesiophobia with TSK heart. | Diagnostic test | Cardiac arrest, Myocardial infarction |
Primary outcome
Physical activity level
Time frame: 7 months after cardiac arrest
Questions about physical activity and physical training (patient reported), accelerometer, performance measure
5 secondary outcomes
Anxiety and Depression
Time frame: 7 months after cardiac arrest
Lower extremity strength
Time frame: 6 months post arrest
Cognitive impairment
Time frame: 6 months post arrest
Kinesiophobia
Time frame: 7 months after cardiac arrest
Cognitive impairment
Time frame: 6 months post arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 39999023Heimburg 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.
- Derived from this study: PubMed 34223342Heimburg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklas Nielsen, MD PhD principal investigator
Lund University
Gisela Lilja, OT PhD study director
Lund University
Tobias Cronberg, PhD MD study director
Lund University
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest, Out-Of-Hospital and Physical Activity, run by Region Skane at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden, United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: 7 months after cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543332, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.