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Completed NCT04261543

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

Conditions: Critical Illness

Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 51
Sponsor: University of Malaya

Location: University of Malaya Kuala Lumpur Kuala Lumpur

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

Eligibility Criteria

Inclusion Criteria: 1. Age 18 years old and above 2. Mechanically ventilated and expected to remain mechanically ventilated for an additional 48 hours from screening 3. 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 Exclusion Criteria: 1. \>96 continuous hours of mechanical ventilation before screening 2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening 3. Pregnant (Note: post-partum and lactating patients are not excluded from the trial) 4. The responsible clinician feels that the patient either needs low or high protein 5. Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group. 6. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted) 7. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury) 8. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 9. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre) 10. Intracranial or spinal process affecting motor function 11. Patients in hospital \>5 days prior to ICU admission 12. Not expected to stay ≥4 days after enrollment 13. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) 14. Lower extremity injury or impairments that prevents cycling (e.g. amputation, knee/hip injury) 15. Weight ≥150 kg 16. Physician declines enrolment for Exercise

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04261543). StuddyBuddy aggregates publicly available trial information.