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出境医 / 临床实验 / Muscle Function After Intensive Care

Muscle Function After Intensive Care

Study Description
Brief 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.

Condition or disease Intervention/treatment
Critically Ill Colorectal Surgery Healthy Muscle Strength Other: Patient follow up

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Muscle Strength and Function After Intensive Care, Compared to Surgical and Healthy Subjects
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018
Arms and Interventions
Group/Cohort Intervention/treatment
Critically ill patients
Patients who spent a minimum of 48h in ICU
 Other: Patient follow up
Patient follow up during one month
Surgical patients
Patients who were scheduled for elective colorectal surgery
 Other: Patient follow up
Patient follow up during one month
Healthy subjects
Healthy volunteers
 Other: Patient follow up
Patient follow up during one month
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Collaborative ICU patients with length of stay > 48h
  • Surgical patients scheduled for colorectal surgery
  • Healthy subjects
Criteria

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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date April 13, 2019
First Posted Date April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date September 1, 2015
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 18, 2019)
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Muscle Function After Intensive Care
Official Title Muscle Strength and Function After Intensive Care, Compared to Surgical and Healthy Subjects
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • Collaborative ICU patients with length of stay > 48h
  • Surgical patients scheduled for colorectal surgery
  • Healthy subjects
Condition
  • Critically Ill
  • Colorectal Surgery
  • Healthy
  • Muscle Strength
Intervention Other: Patient follow up
Patient follow up during one month
Study Groups/Cohorts
  • Critically ill patients
    Patients who spent a minimum of 48h in ICU
    Intervention: Other: Patient follow up
  • Surgical patients
    Patients who were scheduled for elective colorectal surgery
    Intervention: Other: Patient follow up
  • Healthy subjects
    Healthy volunteers
    Intervention: Other: Patient follow up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2019) 		104
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03922113
Other Study ID Numbers FAIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rousseau, University of Liege
Study Sponsor University of Liege
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Liege
Verification Date April 2019

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