Primary Objective: (1) To determine the feasibility of the measurement protocol of a large prospective longitudinal study to describe the exercise capacity and physical functioning of critical illness survivors up to 5 years after discharge from the…
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Brief title
Condition
- Other condition
Synonym
Health condition
Variabel (Intensive Care)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Maximal exercise capacity
The primary outcome measure is the peak oxygen uptake (VO2peak) assessed
through CPET. This measure is considered the gold standard for exercise
capacity, and provides a standardized, objective, and integrated assessment of
the cardiac, respiratory, and musculoskeletal system.
(2) Perceived physical functioning
Measured as the Physical Component Score (PCS) of the Dutch version of the
Short Form 36-item Health Survey (SF-36 survey).
Secondary outcome
(3) Muscle function
For muscle function we will assess measures of muscle strength, muscle quantity
and physical performance. The Medical Research Council score will be used to
assess strength in upper and lower extremity muscle groups. In addition, the
maximal voluntary contraction (MVC) of the knee extensor muscles will be
assessed using a fixed dynamometer. Bioelectrical impedance analysis (BIA) will
be used to estimate the muscle mass as a measure of muscle quantity, and 3d
ultrasound as a measure of muscle quality. As a measure of physical
performance, the 4-m usual walking speed test will be performed. Together these
measures also allow to assess the presence of sarcopenia.
(4) Daily activity
Activity monitors will be used to determine the total step count, and to
establish the total time spent in different individual intensity zones (e.g.
low, moderate and vigorous) during 7 consecutive days. Subjects will also be
asked to keep an activity diary.
(5) Health-related quality of life
Assessed using the Dutch version of the Short Form 36-item Health Survey
(SF36). The physical health component scores and mental health component scores
will be calculated, using age-correlated means and standard deviations of a
healthy Dutch population.
(6) Fatigue
The level of fatigue will be measured using the MFI-20 (Multidimensional
Fatigue Inventory). The MFI-20 is a self-reported instrument to measure fatigue
that was validated in patients with a variety of chronic conditions and has
been used in ICU survivors before.
(7) Endurance capacity.
Endurance capacity will be assessed with the 6 minute walking test (6MWT). The
6MWT provides an integrated assessment of the cardiac, respiratory and
musculoskeletal system during walking. In addition the 2 minute step test
(TMST) will be conducted. There are norm values available for this validated
test for the population of 60 and older, and it is considered an alternative
test for determination of the endurance capacity for participants who are
unable to complete the 6 MWT.
(8) Dietary intake.
Subjects will be asked to keep a dietary intake diary.
(9) Return to work
Information about the manner in which the participant was able to return to
work will be obtained through a self-developed questionnaire.
(10) Mental functioning
Mental functioning will be assessed using the Hospital Anxiety and Depression
Scale (HADS) and The Global Psychotrauma Screen (GPS). The HADS is the most
often used questionnaire to measure symptoms of anxiety and depression in ICU
survivors. The GPS is adapted from the Primary Care PTSD screen (PC-PTSD) and
was recently validated by researchers from the AMC psychiatry department (Dr M.
Olff, publication in progress). The questionnaire consists of 22 items (yes/no
answers) aiming to screen for the presence of psychological trauma as a result
of the critical illness and ICU admission.
(11) Cognitive functioning
ICU survivors experience long-term cognitive impairment. Cognitive functioning
will be measured using the validated abbreviated 14-item Cognitive Failure
Questionnaire (CFQ-14).
Background summary
Several studies evaluated the deleterious effect of critical illness on
physical functioning, with exercise limitations and neuromuscular
abnormalities, during and shortly after hospital discharge. As survival rates
improve among critically ill patients, there is a growing need to also
understand the long-term effects. This information is currently lacking, but
crucial for the development of optimal rehabilitation strategies for critical
illness survivors after hospital discharge. Therefore, we aim to set up a large
prospective longitudinal study to describe the exercise capacity and physical
functioning of critical illness survivors up to 5 years after discharge from
the Intensive Care Unit (ICU) and to explore potential determinants. To
determine the feasibility of the measurement protocol, we will first conduct a
cross-sectional feasibility study, including critical illness survivors in
different phases of their recovery.
Study objective
Primary Objective:
(1) To determine the feasibility of the measurement protocol of a large
prospective longitudinal study to describe the exercise capacity and physical
functioning of critical illness survivors up to 5 years after discharge from
the ICU.
Secondary Objective(s):
(2) To describe the exercise capacity and physical functioning of critical
illness survivors.
(3) To determine potential determinants for exercise capacity and physical
functioning in critical illness survivors.
(4) To describe the relative contribution of cardiac, respiratory, and
musculoskeletal impairment to exercise limitations in critical illness
survivors.
Study design
A cross-sectional feasibility study will be conducted at the outpatient clinic
of the Department of Rehabilitation of the Amsterdam UMC, location AMC.
Study burden and risks
A physician assistant with advanced life support skills will be present during
the exercise tests, minimizing the risk associated with the study procedures.
Subjects will not benefit directly from participation in the study. The group
of mechanically ventilated ICU patients may in the future benefit from the
results as it will increase our understanding of the long-term effects on daily
physical functioning. This will contribute to better rehabilitation strategies
for critical illness survivors after hospital discharge. Therewith the
potential (future) benefits outweigh the burden and minimal risk associated
with the study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
(1) Admitted to an ICU.
(2) Mechanically ventilated >= 24 hours.
(3) Discharged alive from the ICU.
(4) Minimum age of 18 years.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
(1) Contraindication for being physically active (according to the guidelines
by the American College of Sports Medicine).
(2) Documented history of neurologic disease or psychiatric disease or
significant cognitive impairment.
(3) Unable to follow verbal or written instructions.
(4) Insufficient mastery of the Dutch language.
Design
Recruitment
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 | NL71725.018.19 |