Active — Not RecruitingNot Applicable

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

Malaysia120 participantsStarted 2019-08-05

Plain-language 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

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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):

Exclusion criteria

✕. \>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

What they're measuring

Rectus femoris cross-sectional area (RFCSA)

Timeframe: Change in RFCSA between Day 1 and Day 10 of randomization

Rectus femoris cross-sectional area (RFCSA)

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

Rectus femoris linear depth (RF LD)

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

Rectus femoris linear depth (RF LD)

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

Trial details

NCT IDNCT04261543

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Critical Illness trials

Plain-language summary

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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):

Exclusion criteria

✕. \>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

What they're measuring

Rectus femoris cross-sectional area (RFCSA)

Timeframe: Change in RFCSA between Day 1 and Day 10 of randomization

Rectus femoris cross-sectional area (RFCSA)

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

Rectus femoris linear depth (RF LD)

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

Rectus femoris linear depth (RF LD)

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