High Protein Intake and Early Exercise in Adult Intensive Care Patients

NCT03469882 | Completed DMC

• 1 other identifier: ICUHSD 03/18
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critically Ill Patients

Keywords

Protein, exercise, critical illness, outcome,

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• handgrip strength

  20 days

• Duration of mechanical ventilation

  20 days

• Length of ICU stay

  20 days

• Hospital mortality

  6 months

Study Arms (2)

High protein and exercise (HPE) group

EXPERIMENTAL

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; Device: Cycle ergometry exercise

Usual care group

OTHER

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

Other: Usual care group

Interventions

High protein nutrition DIETARY_SUPPLEMENT

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.

High protein and exercise (HPE) group

Cycle ergometry exercise DEVICE

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).

High protein and exercise (HPE) group

Usual care group OTHER

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

Also known as: No intervention

Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Icu Hospital Sao Domingos

São Luís, Maranhão, 65060-645, Brazil

Location

Related Publications (16)

• Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.

  PMID: 24758618 BACKGROUND

• Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.

  PMID: 24247473 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.

  PMID: 24825371 BACKGROUND

• National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.

  PMID: 22307571 BACKGROUND

• Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.

  PMID: 23689848 BACKGROUND

• Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.

  PMID: 25271389 BACKGROUND

• Arabi YM, Aldawood AS, Haddad SH, Al-Dorzi HM, Tamim HM, Jones G, Mehta S, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L; PermiT Trial Group. Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults. N Engl J Med. 2015 Jun 18;372(25):2398-408. doi: 10.1056/NEJMoa1502826. Epub 2015 May 20. Erratum In: N Engl J Med. 2015 Sep 24;373(13):1281. doi: 10.1056/NEJMx150028.

  PMID: 25992505 BACKGROUND

• Allingstrup MJ, Esmailzadeh N, Wilkens Knudsen A, Espersen K, Hartvig Jensen T, Wiis J, Perner A, Kondrup J. Provision of protein and energy in relation to measured requirements in intensive care patients. Clin Nutr. 2012 Aug;31(4):462-8. doi: 10.1016/j.clnu.2011.12.006. Epub 2011 Dec 29.

  PMID: 22209678 BACKGROUND

• Nicolo M, Heyland DK, Chittams J, Sammarco T, Compher C. Clinical Outcomes Related to Protein Delivery in a Critically Ill Population: A Multicenter, Multinational Observation Study. JPEN J Parenter Enteral Nutr. 2016 Jan;40(1):45-51. doi: 10.1177/0148607115583675. Epub 2015 Apr 21.

  PMID: 25900319 BACKGROUND

• Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3.

  PMID: 28374096 BACKGROUND

• Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.

  PMID: 19623052 BACKGROUND

• Gruther W, Pieber K, Steiner I, Hein C, Hiesmayr JM, Paternostro-Sluga T. Can Early Rehabilitation on the General Ward After an Intensive Care Unit Stay Reduce Hospital Length of Stay in Survivors of Critical Illness?: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Sep;96(9):607-615. doi: 10.1097/PHM.0000000000000718.

  PMID: 28181920 BACKGROUND

• Chrispin PS, Scotton H, Rogers J, Lloyd D, Ridley SA. Short Form 36 in the intensive care unit: assessment of acceptability, reliability and validity of the questionnaire. Anaesthesia. 1997 Jan;52(1):15-23. doi: 10.1111/j.1365-2044.1997.015-az014.x.

  PMID: 9014540 BACKGROUND

• Ciconelli RM, Ferraz MB, Santos W, Meirão 1, Quaresma MR. Brazilian-portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Rev Bras Reumatologia. 1999; 39 (3): 143-50.

  BACKGROUND

• de Azevedo JRA, Lima HCM, Frota PHDB, Nogueira IROM, de Souza SC, Fernandes EAA, Cruz AM. High-protein intake and early exercise in adult intensive care patients: a prospective, randomized controlled trial to evaluate the impact on functional outcomes. BMC Anesthesiol. 2021 Nov 13;21(1):283. doi: 10.1186/s12871-021-01492-6.

  PMID: 34773985 DERIVED

MeSH Terms

Conditions

Motor Activity; Critical Illness

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• WIDLANI s MONTENEGRO, RN, Ms

  Hospital Sao Domingos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded outcomes assessment
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 19, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)