High Protein Intake and Early Exercise in Adult Intensive Care Patients

Study Overview
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Brief Summary
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This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.

Detailed Description
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The muscle weakness associated to intensive care, one of the components of Post Intensive Care Syndrome (PICS) has a significant impact on the short-term and long-term outcomes in the critically ill patient (1, 2). Puthucheary et al. (3) analyzed 63 septic patients with imaging examination and established a clear relationship between the number of organ failures and muscle loss in the first 10 days of ICU. Although a study involving 244 critically ill patients has shown an alarming relationship between reduced muscle mass at admission and mortality (4), evidences that nutritional interventions can attenuate muscle loss and result in improvement in outcome are unclear. Recent studies evaluating the impact of nutritional therapy on clinical outcomes have surprisingly demonstrated that patients who received full nutritional intake did not differ in outcomes when compared to those receiving reduced nutritional intake, the so-called permissive underfeeding (5, 6, 7). Careful analysis of these studies, however, reveals that the authors define hyponutrition as synonymous with reduced calorie intake, without mentioning the protein intake offered to the patients. The study with the greatest scientific repercussion (8) used reduced caloric intake in the study group, but the protein intake did not differ between groups. Observational studies comparing high protein intake with conventional intake have shown improvement in outcome indicators in patients receiving more than 1.6 and even more than 2.0 g / kg / day of protein (9, 10). Recently the intensive care medicine research agenda published in the journal of the European Society of Intensive Care Medicine, the top priority of the nutrition research in the critically ill patients was to compare normal and hyperproteic nutrition ideally associated with physical activity (11). Several recent studies have shown benefits of early physical rehabilitation in the critically ill patient (12, 13). The optimal integration between adequate protein intake and exercise in the critically ill patient may have an impact on short- and long-term outcomes, but this hypothesis has not yet been tested by studies with a good methodology. The hypothesis of this prospective randomized phase II study is that the association of high protein intake with early physical rehabilitation improves physical function after hospital discharge with a significant impact on quality of life.

Official Title
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High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.

Conditions
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Critically Ill Patients

Intervention / Treatment
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* Dietary Supplement: High protein nutrition
* Device: Cycle ergometry exercise
* Other: Usual care group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We will include 180 consecutive patients admitted to one of the study ICUs Aged 18 years or above. Non-pregnant. Requiring mechanical ventilation for at least 48 hours. Expected ICU stay higher than 3 days. Exclusion Criteria: Inability to walk without assistance before the acute illness that led to ICU admission (use of gait aid is not an exclusion criterion). Cognitive impairment prior to hospitalization described by relatives and evaluated by the ICU psychology team. Neuromuscular diseases that compromise weaning from mechanical ventilation. Acute pelvic fracture. Unstable spinal cord trauma. Patients considered moribund. In some situations patients will not be included in the resistive exercise program for as long as a temporary limiting factor remains: Patients undergoing neuromuscular blocking drugs. Patients under high-dose vasoactive drug use. Mechanical ventilation with FIO2 (fraction of inspired oxygen) ≥ 60% and / or PEEP (positive end-expiratory pressure)> 12 cm H2O. Intracranial hypertension. . Open abdomen. Status epilepticus.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein and exercise (HPE) group<br>Begining within 48 hours of ICU admission participants will receive nutrition support with energy expenditure measured by indirect calorimetry, 2.0 to 2.2 g/kg/day of protein and in-bed cycle ergometry exercise. | Dietary Supplement: High protein nutrition<br>* Patients in the HPE group will be submitted to nutritional support preferably through the enteral route. Energy expenditure will be determined by indirect calorimetry. They will receive 2.0 to 2.2 grams/kg/day of protein.<br>Device: Cycle ergometry exercise<br>* Patients will be submitted to two daily sessions of exercise (cycle ergometry) 15 minutes duration each, during the 7 days of the week. The intervention will be maintained exclusively duting the patient's stay in the ICU. The cycle ergometer will be the MotoMed Letto II (Reck Technik, Germany).<br>|
| Other: Usual care group<br>Participants randomized to the usual care group will receive usual care protein and exercise | Other: Usual care group<br>* Participants randomized to the usual care group will receive usual care protein and exercise.<br>* Other names: No intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical component summary (PCS) 3 months after randomization | Blind assessment of PCS after 3 months after randomization | 3 months after randomization | 
| Physical component summary (PCS) 6 months after randomization | Blind assessment of PCS after 6 months after randomization | 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| handgrip strength | handgrip strength measured at ICU discharge, | 20 days | 
| Duration of mechanical ventilation | Length of time under mechanical ventilation | 20 days | 
| Length of ICU stay | Length of ICU stay | 20 days | 
| Hospital mortality | Hospital mortality | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein, exercise, critical illness, outcome,