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Trial · NCT03021902

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPhysical functioningHospital discharge (up to 26 weeks after randomization)6-minute walk distance
SecondaryOverall strength-upper extremityHospital discharge (up to 26 weeks after randomization)MRC Sum-score (Medical Research Council (MRC) Scale for Muscle Strength). Subscales scored 0-5, where 5 is normal. Total score is the sum of the 6 upper extremity subscales.
SecondaryOverall strength-lower extremityHospital discharge (up to 26 weeks after randomization)MRC Sum-score (Medical Research Council (MRC) Scale for Muscle Strength). Subscales scored 0-5, where 5 is normal. Total score is the sum of the 6 lower extremity subscales.
SecondaryQuadriceps force-lower extremity strengthHospital discharge (up to 26 weeks after randomization)Hand held dynamometry
SecondaryDistal strength-hand grip strengthICU and hospital discharge (up to 26 weeks after randomization)Hand held dynamometry
SecondaryOverall Physical Functional status - Short Physical Performance BatteryICU and hospital discharge (up to 26 weeks after randomization)Short Physical Performance Battery
SecondaryOverall Physical Functional status - Functional Status Score - ICUICU and hospital discharge (up to 26 weeks after randomization)
Functional Status Score - ICU 5 items are performed: rolling, transfer from supine to sit, sitting at the edge of bed, transfer from sit to stand, and walking Each task is evaluated using an eight-point ordinal scale ranging from 0 (unable to perform) to 7 (complete independence) Item scores are summed The total score ranges from 0-35, with higher scores indicating better physical functioning.
SecondaryMortalityICU and hospital discharge (up to 26 weeks after randomization)Chart review
SecondaryLength of ventilationICU and hospital discharge (up to 26 weeks after randomization)Chart review
SecondaryICU stayICU and hospital discharge (up to 26 weeks after randomization)Chart review
SecondaryHospital stayICU and hospital discharge (up to 26 weeks after randomization)Chart review
SecondaryICU readmissionHospital discharge (up to 26 weeks after randomization)Chart review
SecondaryRe-intubationHospital discharge (up to 26 weeks after randomization)Chart review
SecondaryHospital-acquired infectionsHospital discharge (up to 26 weeks after randomization)Chart review
SecondaryDischarge location (e.g. home vs. rehab)Hospital discharge (up to 26 weeks after randomization)Chart review
SecondaryBody composition - UltrasoundEnrollment, hospital discharge, & ICU discharge (up to 26 weeks after randomization)Ultrasound of quadriceps
SecondaryBody composition - CT - Chest when clinically availableEnrollment, hospital discharge, & ICU discharge (up to 26 weeks after randomization)Chest CT
SecondaryBody composition - CT - Abdominal Scan when clinically availableEnrollment, hospital discharge, & ICU discharge (up to 26 weeks after randomization)Abdominal CT scan at 3rd lumbar vertebra
SecondaryHealth-related quality of life - SF-36Telephone survey at 6 months
36-Item Short Form Health Survey (SF-36) All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100 Items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scale scores represent the average for all items in the scale that the respondent answered.
SecondaryHealth-related quality of life - EQ-5D-5LTelephone survey at 6 monthsEuroQol Group standardized measure of health status (EQ-5D-5L)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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