Physical Activity After Cardiac Arrest; a Sub-study in the Target Temperature Management Trial 2

Physical Activity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543332
• Other study ID #: Cardiac Arrest Physical
• Status: Completed
• Start date: July 21, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Heart Arrest
• Heart Arrest, Out-Of-Hospital
• Out-of-Hospital Cardiac Arrest
• Physical Activity

Intervention

Diagnostic Test:
• Measures of physical activity and kinesiophobia
Groups will be compared regarding kinesiophobia with TSK heart.

Locations

Country	Name	City	State
Denmark	Hans Kirkegaard	Aarhus
Sweden	Salgrenska University Hospital	Göteborg
Sweden	Halmstad Hospital	Halmstad
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Skane University Hospital Lund	Lund
Sweden	Skane University hospital	Malmö
United Kingdom	Thomas Keeble	Basildon	Essex
United Kingdom	Mattthew P Wise	Cardiff

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Halmstad County Hospital, Lund University, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level	Questions about physical activity and physical training (patient reported), accelerometer, performance measure	7 months after cardiac arrest
Secondary	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.	7 months after cardiac arrest
Secondary	Lower extremity strength	Timed-Stands Test (TST) assess the overall physical function by assessing lower extremity strength	6 months post arrest
Secondary	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	6 months post arrest
Secondary	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.	7 months after cardiac arrest
Secondary	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.	6 months post arrest