High Protein Intake and Early Exercise in Adult Intensive Care Patients

July 24, 2021 updated by: José Raimundo Araujo de Azevedo, Hospital Sao Domingos

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Maranhão
      • Sao Luis, Maranhão, Brazil, 65060-645
        • Icu Hospital Sao Domingos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High protein and exercise (HPE) group
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
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.
Device: Cycle ergometry exercise
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).
Other: Usual care group
Participants randomized to the usual care group will receive usual care protein and exercise
Other: Usual care group
Participants randomized to the usual care group will receive usual care protein and exercise.
Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical component summary (PCS) 3 months after randomization
Time Frame: 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
Time Frame: 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
Time Frame: 20 days
handgrip strength measured at ICU discharge,
20 days
Duration of mechanical ventilation
Time Frame: 20 days
Length of time under mechanical ventilation
20 days
Length of ICU stay
Time Frame: 20 days
Length of ICU stay
20 days
Hospital mortality
Time Frame: 6 months
Hospital mortality
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Domingos

Investigators

  • Study Director: WIDLANI s MONTENEGRO, RN, Ms, Hospital São Domingos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

March 11, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 24, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICUHSD 03/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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