The Effect of High Protein and Early Resistance Exercise Versus Usual Care in Critically Ill Patients

NCT04261543 | Active Not Recruiting

• 1 other identifier: MREC ID NO: 20181115-6890
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-arm, parallel-group, randomized controlled trial that investigates the effect of combined high protein and early resistance exercise versus usual care on muscle mass, quality and strength, clinical outcomes, functional outcomes and quality of life in mechanically ventilated critically ill patients

Conditions

Critical Illness

Keywords

protein; exercise; muscle

Outcome Measures

Primary Outcomes (4)

• Rectus femoris cross-sectional area (RFCSA)

  RFCSA measured by ultrasonography

  Change in RFCSA between Day 1 and Day 10 of randomization

• Rectus femoris cross-sectional area (RFCSA)

  RFCSA measured by ultrasonography

  Change in RFCSA between Day 1 of randomization and within 72 hours before discharge from the hospital

• Rectus femoris linear depth (RF LD)

  RF LD measured by ultrasonography

  Change in RF LD between Day 1 and Day 10 of randomization

• Rectus femoris linear depth (RF LD)

  RF LD measured by ultrasonography

  Change in RF LD between Day 1 of randomization and within 72 hours before discharge from the hospital

Secondary Outcomes (16)

• Quadriceps muscle echogenicity

  Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital

• Quadriceps muscle pennation angle

  Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital

• Quadriceps muscle fascicle length

  Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital

• Functional Status Score for the Intensive Care Unit (FSS-ICU)

  Day 1 of randomization (surrogate interview), within 72 hours before discharge from the ICU and hospital (by trained physiotherapist)

• Short Physical Performance Batteries (SPPB)

  Within 72 hours before discharge from the ICU and hospital

Study Arms (2)

High Protein and Early Exercise

EXPERIMENTAL

High protein is defined as a protein prescription of ≥2.2 gram/kg body weight; Early exercise is defined as exercise by using cycle ergometry for 45 minutes per day within 24 hours of randomization

Other: High protein and early exercise

Usual Care

ACTIVE COMPARATOR

Usual care has a protein prescription of ≤1.2 gram/kg body weight and exercise prescription as per the discretion of attending clinicians

Other: Usual Care

Interventions

High protein and early exercise OTHER

High protein is defined as protein prescription of ≥2.2 gram/kg body weight and early exercise is defined as starting cycle ergometry intervention within 24 hours of randomization

High Protein and Early Exercise

Usual Care OTHER

Usual care group has protein prescription of ≤1.2 gram/kg body weight and exercise at the discretion of attending clinicians

Usual Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old and above
• Mechanically ventilated and expected to remain mechanically ventilated for an additional 48 hours from screening
• High nutritional risk (at least one of the following):
• BMI ≤ 25 or ≥ 35
• Moderate to severe malnutrition as defined by Subjective Global Assessment (SGA)
• Frailty (Clinical Frailty Scale ≥ 5 from proxy)
• SARC-F (note: 'sarc-f' is the full name, not an abbreviation) questionnaire ≥ 4
• From point of screening, projected duration of mechanical ventilation of \>4 days

You may not qualify if:

• \>96 continuous hours of mechanical ventilation before screening
• Expected death or withdrawal of life-sustaining treatments within 7 days from screening
• Pregnant (Note: post-partum and lactating patients are not excluded from the trial)
• The responsible clinician feels that the patient either needs low or high protein
• Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.
• Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted)
• Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)
• Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
• Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)
• Intracranial or spinal process affecting motor function
• Patients in hospital \>5 days prior to ICU admission
• Not expected to stay ≥4 days after enrollment
• Lower extremity injury or impairments that prevents cycling (e.g. amputation, knee/hip injury)
• Weight ≥150 kg
• Physician declines enrolment for Exercise

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (3)

• Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

  PMID: 21470008 BACKGROUND

• Heyland DK, Stapleton RD, Mourtzakis M, Hough CL, Morris P, Deutz NE, Colantuoni E, Day A, Prado CM, Needham DM. Combining nutrition and exercise to optimize survival and recovery from critical illness: Conceptual and methodological issues. Clin Nutr. 2016 Oct;35(5):1196-206. doi: 10.1016/j.clnu.2015.07.003. Epub 2015 Jul 16.

  PMID: 26212171 BACKGROUND

• Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3.

  PMID: 28374096 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Zheng Yii Lee

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 7, 2020
• Study Start: August 5, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)