The Effect of High Protein and Early Resistance Exercise Versus Usual Care in Critically Ill Patients (EFFORT-X Trial)

STATUS

Recruiting
participants needed

120
sponsor

University of Malaya

Updated on 19 February 2024

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Summary

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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

Description

With the advancement of critical care, about 80% of ICU patients are surviving critical illness. However, ICU survivors often experience significant post-ICU morbidities including muscle weakness and impairments in physical functioning that can persist for years. We hypothesized that early intervention with two of the most basic features of critical care: nutrition (feeding high protein) together with mobility (early resistance exercise) may help to attenuate muscle loss, thereby reducing the severity of ICU-acquired weakness and its associated physical impairments. A 2-arm, parallel-group, randomized controlled trial is proposed to investigate the effect of the combined interventions. The intervention will be conducted for up to 28 days in the ICU. Outcome measurements will be conducted by a blinded assessor at baseline (within 24 hours of randomization), Day 10 post-randomization, before hospital discharge and at 6-month post-randomization. Ultrasound and bioelectrical impedance analysis will be conducted to measure muscle mass and quality. Manual muscle testing, handgrip and knee extension strength will also be measured. Physical function will be assessed by a series of test including the six minutes walk test. Telephone interview will be conducted to administer quality of life questionnaires at 6 months. These combined simple and non-invasive interventions, if proven effective, may potentially revolutionize critical care.

Details

Condition	Critical Illness
Age	18years - 90years
Treatment	Usual care, High protein and early exercise
Clinical Study Identifier	NCT04261543
Sponsor	University of Malaya
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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)
	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
	>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
	Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
	Lower extremity injury or impairments that prevents cycling (e.g. amputation, knee/hip injury)
	Weight 150 kg
	Physician declines enrolment for Exercise

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The Effect of High Protein and Early Resistance Exercise Versus Usual Care in Critically Ill Patients (EFFORT-X Trial)

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The Effect of High Protein and Early Resistance Exercise Versus Usual Care in Critically Ill Patients (EFFORT-X Trial)

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