Muscle Function After Intensive Care

Final objective of critical care is no longer only survival. The role of medical and paramedical teams should also be to restore functional capacities, autonomy and quality of life. What has been call "intensive care unit - acquired weakness" (ICU-AW) is associated to acute and long term increased mortality, prolonged ICU and hospital stay, prolonged duration of mechanical ventilation, altered quality of life in survivors and increased health-related costs. In order to target efficient secondary prevention and early rehabilitation, prompt identification of muscle weakness is crucial. Several methods, aiming to assess muscle mass, muscle strength or physical function, are described. Manual muscle testing using the Medical Research Council (MRC) scale is still the most commonly utilized tool to diagnose ICU-AW (MRC <48/60). Dynamometry is an objective alternative and one of the most accurate clinimetric tool to assess muscle strength. Literature is overflowing with insufficiently standardized dynamometry data. Using the investigator's published standardized protocol of quadriceps strength (QS) assessment, this observational study aim to describe physical performances of CC patients and thus to define the weakest ones, by comparing them to surgical and healthy subjects.

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Key information

Conditions

Critically Ill Colorectal Surgery Critical Illness Disease Attributes Healthy Muscle Strength Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Collaborative ICU patients with length of stay > 48h
Surgical patients scheduled for colorectal surgery
Healthy subjects

Exclusion criteria

a score > 1 or < -1 on the Richmond Agitation and Sedation Scale (RASS)
coma
total hip or knee arthroplasty in the dominant limb
unauthorized support on the dominant leg
open wound located at the ankle's anterior face of the dominant leg
pre-existing myopathy or polyneuropathy
para- or tetraparesis, para- or tetraplegia
refusal.

Treatment and study plan

Patient follow up

Other

Patient follow up during one month

Primary outcomes

Change in Quadriceps strength

Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0

Maximal isometric voluntary quadriceps contraction is assessed using a hand-held dynamometer (MicroFet2®, Hoggan Health Industries, West Jordan, UT, USA) with a curved transducer pad. The highly standardized protocol is detailed in a previously published validation study (Rousseau et al, Acta Anaesthesiologica Belgica 2018). Measurements are performed at bedside with patient lying on supine position. The dominant limb is tested (kicking leg). The best performance out of 3 measurements is considered for the analysis. Muscle strength is expressed in Newton (N). Relative strength, normalized according to actual body weight, is expressed in N/kg.

Secondary outcomes

Change in Medical Research Council test (MRC)

Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0

Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.
Change in 4-items Physical Function Intensive care Test (PFIT-s)

Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0

This test measures strength and functional outcomes, by ranking 4 components: assistance (sit and stand), cadence (steps/min), shoulder flexion strength and knee extension strength. Maximal score is 10.
Change in Barthel index for activities of daily living

Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0

This score assesses functional independence by ranking patient's independence in the following areas: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility in level surfaces and stairs. Maximal total score is 100 = totally independent).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Muscle Strength and Function After Intensive Care, Compared to Surgical and Healthy Subjects

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Apr 19, 2019
Registry last updated: Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed