Muscle Function After Intensive Care

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922113
• Other study ID #: FAIC
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2019
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Surgery
• Critical Illness
• Critically Ill
• Healthy
• Muscle Strength

Intervention

Other:
• Patient follow up
Patient follow up during one month

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quadriceps strength	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.	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
Secondary	Change in Medical Research Council test (MRC)	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.	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
Secondary	Change in 4-items Physical Function Intensive care Test (PFIT-s)	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.	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
Secondary	Change in Barthel index for activities of daily living	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).	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