1] To explore the course of performance-based physical functional recovery at ICU admission, hospital discharge, three months post-hospital discharge and at six months post-hospital discharge of ICU survivors who have been * 48 at mechanical…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
criticall ilness, multi-orgaanfalen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1] Performance-based physical function;
Secondary outcome
2] Cardiorespiratory fitness; 3] Self-reported physical function pre-ICU
admission; 4] (Health Related) Quality of life; 5] Psychological distress; 6]
Self-reported daily physical activity; 7] Self-reported use of healthcare
resources; 8] Participation in work and/or study; 9] Global perceived recovery
in comparison to pre-ICU status; 10] Proportion of included patients who
completed entire follow-up per protocol
Background summary
Prolonged mechanical ventilation in critical ill patients during intensive care
unit (ICU) stay can lead to general skeletal muscle weakness and muscle
dysfunction, which hampers physical functioning and cardiorespiratory fitness
on the short and longer term.
Study objective
1] To explore the course of performance-based physical functional recovery at
ICU admission, hospital discharge, three months post-hospital discharge and at
six months post-hospital discharge of ICU survivors who have been * 48 at
mechanical ventilation; 2] To explore: A] Cardiorespiratory fitness levels
three and six months post-hospital discharge; B] Self-reported physical
function pre-ICU admission; C] (Health Related) Quality of life three and six
months post-hospital discharge; D] Psychological distress six months
post-hospital discharge; E] Self-reported daily physical activity levels three
and six months post-hospital discharge; F] Self-reported use of healthcare
resources three and six months post-hospital discharge; G] Participation in
work and/or study three and six months post-hospital; H] Global perceived
recovery in comparison to pre-ICU status at hospital discharge, three months
post-hospital discharge and six months post-hospital discharge;I] Proportion of
included patients who completed entire follow-up per protocol.
Study design
A single-centre, prospective cohort design.
Study burden and risks
The performance based-tests during ICU and hospital stay are part of usual
care. Furthermore, the performance-based tests mimic daily life physical
activities, so no extra burden associated with testing is expected during
follow-up after hospital discharge when patient are at home or at a
rehabilitation setting. Additionally, maximal symptom-limited exercise testing
is reported to be a safe procedure, even in ICU survivors and severe
deconditioned patient groups. Safety procedures will be followed before, during
and after maximal exercise testing. Hence, no extra burden associated with
study participation is expected by the questionnaires which do not impact or
influence patient behaviour.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
- * 18 years
- having received between * 48 hours of mechanical ventilation
- conscious and adequate (Richmond Agitation and Sedation Scale (RASS) score *
2)
- cooperative (Standard 5 Questions * 3)
- free from delirium for at least 24 hours (i.e. being eligible to test)
Exclusion criteria
- pre-existing orthopaedic or neuromuscular comorbidity that affects adequate
physical function assessment
- central neurologic or spinal cord pathology
- non-ambulatory prior to ICU admission
- receiving palliative care
- Insufficient understanding of the Dutch language
- Unable to give written informed consent to participate in the study
- Not eligible to perform maximal exercise testing at 3-6 months post-ICU
discharge using the American College of Sports Medicine screening form (ACSM,
1998)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68583.058.18 |