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

N/AActive Not RecruitingNCT04261543

University of Malaya120 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Critical Illness

Interventions

High protein and early exerciseOTHER

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

Usual CareOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Rectus femoris cross-sectional area (RFCSA)

RFCSA measured by ultrasonography

Time frame: Change in RFCSA between Day 1 and Day 10 of randomization

Rectus femoris cross-sectional area (RFCSA)

RFCSA measured by ultrasonography

Time frame: 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

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

Rectus femoris linear depth (RF LD)

RF LD measured by ultrasonography

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

Secondary Outcomes

Quadriceps muscle echogenicity

Quadriceps muscle echogenicity measured by ultrasonography

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

Quadriceps muscle pennation angle

Quadriceps muscle pennation angle measured by ultrasonography

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

Quadriceps muscle fascicle length

Quadriceps muscle fascicle length measured by ultrasonography

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

Data from ClinicalTrials.gov

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