CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
High protein nutrition +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03469882
NCT03469882N/ACompleted
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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.

Hospital Sao Domingos·interventional·Posted Mar 19, 2018·Updated Jul 30, 2021

In Brief

A clinical study evaluating High protein nutrition, Cycle ergometry exercise, and 1 other intervention for Critically Ill Patients. Completed, enrolled 180 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritically Ill Patients
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartJun 1, 2018
Primary CompletionDec 31, 2019
Study CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.3 years ago

Interventions

High protein nutritiondietary

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.

Cycle ergometry exercisedevice

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).

Usual care groupother

Participants randomized to the usual care group will receive usual care protein and exercise.