Feeding With Indirect Calorimetry and Cycling in the Elderly (FICE)
Primary Purpose
Calorimetry, Indirect, Exercise Therapy, Critical Care
Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Indirect Calorimetry directed feeding.
Cycle Ergometry
Sponsored by
About this trial
This is an interventional treatment trial for Calorimetry, Indirect
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- National University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1. Control
2. Intervention
Arm Description
Standard physiotherapy Empiric formula directed feeding (daily caloric requirement calculated by 25 kcal/kg/day)
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)
Outcomes
Primary Outcome Measures
Change in quadriceps muscle thickness
Change in quadriceps muscle thickness
Secondary Outcome Measures
MRC-ss
Measurement of functional outcome.
MRC-ss
Measurement of functional outcome.
MRC-ss
Measurement of functional outcome.
FSS-ICU
Measurement of functional outcome.
FSS-ICU
Measurement of functional outcome.
FSS-ICU
Measurement of functional outcome.
CPax
Measurement of functional outcome.
CPax
Measurement of functional outcome.
CPax
Measurement of functional outcome.
Quadriceps strength and hand grip strength
Measured with dynamometer.
Quadriceps strength and hand grip strength
Measured with dynamometer.
Quadriceps strength and hand grip strength
Measured with dynamometer.
Length of Stay in ICU
Length of Stay in ICU
Length of hospital stay
Length of hospital stay
Full Information
NCT ID
NCT03540732
First Posted
January 31, 2018
Last Updated
July 24, 2023
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03540732
Brief Title
Feeding With Indirect Calorimetry and Cycling in the Elderly
Acronym
FICE
Official Title
Feeding With Indirect Calorimetry and Cycling in the Elderly Intensive Care Patient
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Patients admitted to ICU are normally ventilated due to their critical illness and sedated for their comfort. This prolonged immobility from sedation leads to accelerated muscle atrophy and reconditioning when they recover from their critical illness. This leads to further complications from immobility like bed sores, hospital acquired infections, deep vein thrombosis and pulmonary embolisms. Many patients do not return to their pre-illness level of function and require long term care.
Nutrition is frequently hard to assess when patients is in a catabolic state and sedated. There is a loss of appetite if the patient is awake to express it, and if sedated is depended on nasogastric feeding based on caloric empirical formulas invented more than 50 years ago. These formulas also do not accurately take into account exercise physiotherapy which patients will undergo while on ICU. With indirect calorimetry (IC), patients energy requirements can be estimated on a daily basis and can be fed accordingly. The IC is considered the gold standard in many guidelines for nutritional assessments but it is not commonly used due to cost and practical difficulties in measurements. The investigators intend to use the IC based on international recommendations to assess energy requirements daily and feed patients based on the data provided by the IC.
Early rehabilitative type of exercises have been show to increase muscle mass and reduce length of stay in the elderly geriatric population by preventing deconditioning. There is some evidence that this also applies to the ICU population but in a ventilated patient on multiple therapies, this is extremely labour intensive. By utilising the cycle ergometry, this muscle atrophy may be reduced. Interestingly, studies on intensive physiotherapy have not shown to have a dramatic outcome in the elderly ICU population. This could be due to the catabolic rates and the inadequate feeding of a sedated patient who cannot express their hunger or satiety. By using the indirect calorimetry, a more accurate energy expenditure can be estimated and nutrition can be targeted. By combining these 2 therapies, the lengths of stay in hospital can be reduced and functional outcomes improved in this silver population.
The investigators plan to conduct a randomised controlled trial. Participants will be randomised into 2 groups; the intervention and control group. Participants in the control group will receive standard empiric weight based feeding and standard physiotherapy. Participants in the intervention group will undergo daily IC measurements on admission and fed according to the energy expenditure measured by IC. In addition to standard physiotherapy, the participants in the intervention group will undergo cycle ergometry for up to 60 minutes daily. The participants in the intervention group will undergo 14 days of IC and cycle ergometry or until extubation (for IC), whichever is earlier.
During this 14 day period, participants in both groups will undergo twice weekly quadriceps muscle ultrasounds to assess muscle thickness as a surrogate measure of muscle atrophy. After this 14 day period, the investigators will perform regular assessments of functional status (during the ICU/HD stay, on discharge to general ward, and on discharge from hospital). The investigators will also collect demographic and ICU assessment data from medical records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calorimetry, Indirect, Exercise Therapy, Critical Care, Muscular Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Outcome assessor (in our study, person measuring participants' quadriceps muscle thickness) is blinded.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1. Control
Arm Type
No Intervention
Arm Description
Standard physiotherapy
Empiric formula directed feeding (daily caloric requirement calculated by 25 kcal/kg/day)
Arm Title
2. Intervention
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Indirect Calorimetry directed feeding.
Intervention Description
Indirect calorimetry directed feeding (use of indirect calorimetry to calculate daily caloric requirement)
Intervention Type
Procedure
Intervention Name(s)
Cycle Ergometry
Intervention Description
Up to 60 minutes of cycle ergometry daily in addition to standard physiotherapy sessions.
Primary Outcome Measure Information:
Title
Change in quadriceps muscle thickness
Description
Change in quadriceps muscle thickness
Time Frame
Change in thickness of quadriceps muscle (as assessed by ultrasound scanning) over the first 2 weeks of study.
Secondary Outcome Measure Information:
Title
MRC-ss
Description
Measurement of functional outcome.
Time Frame
On discharge from ICU, up to 1 year from recruitment.
Title
MRC-ss
Description
Measurement of functional outcome.
Time Frame
14 days after recruitment
Title
MRC-ss
Description
Measurement of functional outcome.
Time Frame
On discharge from hospital, up to 1 year from recruitment.
Title
FSS-ICU
Description
Measurement of functional outcome.
Time Frame
On discharge from ICU, up to 1 year from recruitment.
Title
FSS-ICU
Description
Measurement of functional outcome.
Time Frame
14 days after recruitment
Title
FSS-ICU
Description
Measurement of functional outcome.
Time Frame
On discharge from hospital, up to 1 year from recruitment.
Title
CPax
Description
Measurement of functional outcome.
Time Frame
On discharge from ICU, up to 1 year from recruitment.
Title
CPax
Description
Measurement of functional outcome.
Time Frame
14 days after recruitment
Title
CPax
Description
Measurement of functional outcome.
Time Frame
On discharge from hospital, up to 1 year from recruitment.
Title
Quadriceps strength and hand grip strength
Description
Measured with dynamometer.
Time Frame
On discharge from ICU, up to 1 year from recruitment.
Title
Quadriceps strength and hand grip strength
Description
Measured with dynamometer.
Time Frame
14 days after recruitment
Title
Quadriceps strength and hand grip strength
Description
Measured with dynamometer.
Time Frame
On discharge from hospital, up to 1 year from recruitment.
Title
Length of Stay in ICU
Description
Length of Stay in ICU
Time Frame
Day of discharge from ICU, up to 1 year from recruitment.
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
Day of discharge from hospital, up to 1 year from recruitment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Will NH Loh, MBBS
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Health System
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24108501
Citation
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Results Reference
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Results Reference
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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.
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Feeding With Indirect Calorimetry and Cycling in the Elderly
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