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Physical recovery of Intensive Care Unit survivors.

Physical recovery of Intensive Care Unit survivors. - Physical recovery of ICU survivors.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48487
Enrollment
30
Registered
2019-12-12
Start date
2020-09-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Variabel (Intensive Care) Critical illness Post-intensive care syndrome (PICS)

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
(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

MeasureTime frame
(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 end

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026