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

University of Malaya

Status: Active, not recruiting

Conditions: Critical Illness

Treatments: Other: High protein and early exercise; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04261543

MREC ID NO: 20181115-6890

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

High Protein and Early Exercise

Experimental group

Description:

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

Treatment:

Other: High protein and early exercise

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care