Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT03543332
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity level', 'timeFrame': '7 months after cardiac arrest', 'description': 'Questions about physical activity and physical training (patient reported), accelerometer, performance measure'}], 'secondaryOutcomes': [{'measure': 'Anxiety and Depression', 'timeFrame': '7 months after cardiac arrest', 'description': '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.'}, {'measure': 'Lower extremity strength', 'timeFrame': '6 months post arrest', 'description': 'Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength'}, {'measure': 'Cognitive impairment', 'timeFrame': '6 months post arrest', 'description': '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'}, {'measure': 'Kinesiophobia', 'timeFrame': '7 months after cardiac arrest', 'description': '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.'}, {'measure': 'Cognitive impairment', 'timeFrame': '6 months post arrest', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical training', 'Kinesiophobia'], 'conditions': ['Heart Arrest, Out-Of-Hospital', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '39999023', 'type': 'DERIVED', 'citation': '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': '34223342', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.\n\nAn 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.'}, 'identificationModule': {'nctId': 'NCT03543332', 'briefTitle': 'Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'Cardiac Arrest Physical'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac arrest', 'interventionNames': ['Diagnostic Test: Measures of physical activity and kinesiophobia']}, {'label': 'Myocardial infarction', 'description': 'Myocardial infarction without cardiac arrest', 'interventionNames': ['Diagnostic Test: Measures of physical activity and kinesiophobia']}], 'interventions': [{'name': 'Measures of physical activity and kinesiophobia', 'type': 'DIAGNOSTIC_TEST', 'description': 'Groups will be compared regarding kinesiophobia with TSK heart.', 'armGroupLabels': ['Cardiac arrest', 'Myocardial infarction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Hans Kirkegaard', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Salgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Halmstad', 'country': 'Sweden', 'facility': 'Halmstad Hospital', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Helsingborg Hospital', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skane University Hospital Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skane University hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Thomas Keeble', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Mattthew P Wise', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Niklas Nielsen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}, {'name': 'Gisela Lilja, OT PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lund University'}, {'name': 'Tobias Cronberg, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lund University'}, {'name': 'Åsa B Tornberg, RPT PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}, {'name': 'Halmstad County Hospital', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}