Feeding With Indirect Calorimetry and Cycling in the Elderly

NCT03540732 | Unknown DMC

• 1 other identifier: 2017/00573
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of early exercise by cycle ergometry and early targeted feeding in reducing muscle atrophy and improve functional outcomes in the older critically ill patient.

Conditions

Calorimetry, Indirect; Exercise Therapy; Critical Care; Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• Change in quadriceps muscle thickness

  Change in quadriceps muscle thickness

  Change in thickness of quadriceps muscle (as assessed by ultrasound scanning) over the first 2 weeks of study.

Secondary Outcomes (14)

• MRC-ss

  On discharge from ICU, up to 1 year from recruitment.

• MRC-ss

  14 days after recruitment

• MRC-ss

  On discharge from hospital, up to 1 year from recruitment.

• FSS-ICU

  On discharge from ICU, up to 1 year from recruitment.

• FSS-ICU

  14 days after recruitment

Study Arms (2)

1. Control

NO INTERVENTION

* Standard physiotherapy * Empiric formula directed feeding (daily caloric requirement calculated by 25 kcal/kg/day)

2. Intervention

ACTIVE COMPARATOR

* Up to 60 minutes of cycle ergometry daily in addition to standard physiotherapy sessions. * Indirect calorimetry directed feeding (use of indirect calorimetry to calculate daily caloric requirement)

Other: Indirect Calorimetry directed feeding.; Procedure: Cycle Ergometry

Interventions

Indirect Calorimetry directed feeding. OTHER

Indirect calorimetry directed feeding (use of indirect calorimetry to calculate daily caloric requirement)

2. Intervention

Cycle Ergometry PROCEDURE

Up to 60 minutes of cycle ergometry daily in addition to standard physiotherapy sessions.

2. Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 60 years old
• Mechanically ventilated within 3 days of ICU admission
• Expected to be mechanically ventilated for more than 3 days at time of recruitment
• Able to ambulate with or without a gait aid before hospitalization
• Able to be enterally fed within 48 hours of ICU admission

You may not qualify if:

• Unable to follow commands at baseline before hospital admission (e.g. Severe dementia)
• Acute condition where cycling is a contraindication (e.g. leg fracture)
• Not expected to survive the subsequent 48 hours
• Body habitus unable to fit the cycle ergometry
• Patients at high risk of refeeding (i.e. NUTRIC score \>= 5): malnourished patients with anorexia nervosa, chronic malabsorption syndromes, chronic alcoholism, or patients with massive weight loss.
• Extremes of BMI: i.e. BMI \< 16 or \> 30
• Liver failure
• Cycling exemptions precluding cycling within the first 4 days of mechanical ventilation
• Requirement for inspired oxygen content (FiO2) greater than 0.8
• Expected to be on renal replacement therapy for longer than 12 hours per session
• PEEP \> 15mmHg
• Air leaks through chest drains
• Palliative goals of care or limitation of treatment established by the CARE form
• Readmissions to ICU

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Health System

Singapore, 119074, Singapore

Location

Related Publications (10)

• 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

• Wei X, Day AG, Ouellette-Kuntz H, Heyland DK. The Association Between Nutritional Adequacy and Long-Term Outcomes in Critically Ill Patients Requiring Prolonged Mechanical Ventilation: A Multicenter Cohort Study. Crit Care Med. 2015 Aug;43(8):1569-79. doi: 10.1097/CCM.0000000000001000.

  PMID: 25855901 BACKGROUND

• Wichansawakun S, Meddings L, Alberda C, Robbins S, Gramlich L. Energy requirements and the use of predictive equations versus indirect calorimetry in critically ill patients. Appl Physiol Nutr Metab. 2015 Feb;40(2):207-10. doi: 10.1139/apnm-2014-0276. Epub 2014 Oct 27.

  PMID: 25610953 BACKGROUND

• Parry SM, Huang M, Needham DM. Evaluating physical functioning in critical care: considerations for clinical practice and research. Crit Care. 2017 Oct 4;21(1):249. doi: 10.1186/s13054-017-1827-6.

  PMID: 28978333 BACKGROUND

• Reid CL. Poor agreement between continuous measurements of energy expenditure and routinely used prediction equations in intensive care unit patients. Clin Nutr. 2007 Oct;26(5):649-57. doi: 10.1016/j.clnu.2007.02.003. Epub 2007 Apr 6.

  PMID: 17418917 BACKGROUND

• Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.

  PMID: 21340655 BACKGROUND

• Kho ME, Molloy AJ, Clarke FJ, Ajami D, McCaughan M, Obrovac K, Murphy C, Camposilvan L, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Zanni JM, Mourtzakis M, Piraino T, Cook DJ; Canadian Critical Care Trials Group. TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients. PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016.

  PMID: 28030555 BACKGROUND

• Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, Rafferty G, Polkey MI, Moxham J. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009 May;64(5):418-23. doi: 10.1136/thx.2008.103986. Epub 2009 Jan 21.

  PMID: 19158125 BACKGROUND

• Petros S, Engelmann L. Validity of an abbreviated indirect calorimetry protocol for measurement of resting energy expenditure in mechanically ventilated and spontaneously breathing critically ill patients. Intensive Care Med. 2001 Jul;27(7):1164-8. doi: 10.1007/s001340100941.

  PMID: 11534564 BACKGROUND

• Elizabeth NSH, Yanni T, May LS, Fen TH, Janice LX, Peijun K, Pheng OS, Jie TS, Will LNH. Indirect calorimetry directed feeding and cycling in the older ICU population: a pilot randomised controlled trial. BMC Anesthesiol. 2024 May 7;24(1):171. doi: 10.1186/s12871-024-02507-8.

  PMID: 38714926 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Will NH Loh, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor (in our study, person measuring participants' quadriceps muscle thickness) is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: May 30, 2018
• Study Start: November 6, 2017
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-06

Locations

SG (1)