Calorimetry, IndirectFICENCT03540732
Feeding With Indirect Calorimetry and Cycling in the Elderly
A study testing Indirect Calorimetry directed feeding. and Cycle Ergometry in people with Calorimetry, Indirect and Exercise Therapy, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Calorimetry, Indirect, Exercise Therapy, Critical Care
- What is being tested?
- Indirect Calorimetry directed feeding. and Cycle Ergometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Nov 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feeding With Indirect Calorimetry and Cycling in the Elderly Intensive Care Patient
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.
Read the 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.
- Being tested
- Indirect Calorimetry directed feeding., Cycle Ergometry
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect Calorimetry directed feeding.Other
Indirect calorimetry directed feeding (use of indirect calorimetry to calculate daily caloric requirement)
Cycle ErgometryProcedure or surgery
Up to 60 minutes of cycle ergometry daily in addition to standard physiotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Indirect Calorimetry directed feeding.; Procedure: Cycle Ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle thickness
Change in quadriceps muscle thickness
Measured: Change in thickness of quadriceps muscle (as assessed by ultrasound scanning) over the first 2 weeks of study.
Secondary outcomes (14)
MRC-ss
Measurement of functional outcome.
Measured: On discharge from ICU, up to 1 year from recruitment.
MRC-ss
Measurement of functional outcome.
Measured: 14 days after recruitment
MRC-ss
Measurement of functional outcome.
Measured: On discharge from hospital, up to 1 year from recruitment.
FSS-ICU
Measurement of functional outcome.
Measured: On discharge from ICU, up to 1 year from recruitment.
FSS-ICU
Measurement of functional outcome.
Measured: 14 days after recruitment
FSS-ICU
Measurement of functional outcome.
Measured: On discharge from hospital, up to 1 year from recruitment.
CPax
Measurement of functional outcome.
Measured: On discharge from ICU, up to 1 year from recruitment.
CPax
Measurement of functional outcome.
Measured: 14 days after recruitment
CPax
Measurement of functional outcome.
Measured: On discharge from hospital, up to 1 year from recruitment.
Quadriceps strength and hand grip strength
Measured with dynamometer.
Measured: On discharge from ICU, up to 1 year from recruitment.
Quadriceps strength and hand grip strength
Measured with dynamometer.
Measured: 14 days after recruitment
Quadriceps strength and hand grip strength
Measured with dynamometer.
Measured: On discharge from hospital, up to 1 year from recruitment.
Length of Stay in ICU
Length of Stay in ICU
Measured: Day of discharge from ICU, up to 1 year from recruitment.
Length of hospital stay
Length of hospital stay
Measured: Day of discharge from hospital, up to 1 year from recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start6 Nov 2017
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Calorimetry, IndirectStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Will NH Loh, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540732
- Sponsor's protocol ID
- 2017/00573
- Other IDs
- 2017
- Acronym
- FICE
- Status last verified
- Jun 2023
- First submitted
- 31 Jan 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24108501Wei 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.
PubMed 25855901Wichansawakun 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.
PubMed 25610953Parry 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.
PubMed 28978333Reid 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.
PubMed 17418917Singer 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.
PubMed 21340655Kho 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.
PubMed 28030555Seymour 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.
PubMed 19158125Petros 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.
PubMed 11534564Elizabeth 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.
PubMed 38714926
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding With Indirect Calorimetry and Cycling in the Elderly Intensive Care Patient
- ClinicalTrials.gov ID
- NCT03540732
- Acronym / sponsor ID
- FICE / 2017/00573
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 1. Control | No intervention | –* Standard physiotherapy * Empiric formula directed feeding (daily caloric requirement calculated by 25 kcal/kg/day) |
| 2. Intervention | Active comparator | Other: Indirect Calorimetry directed feeding., Procedure: Cycle Ergometry* 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect Calorimetry directed feeding.Indirect calorimetry directed feeding (use of indirect calorimetry to calculate daily caloric requirement) | Other | 2. Intervention |
| Cycle ErgometryUp to 60 minutes of cycle ergometry daily in addition to standard physiotherapy sessions. | Procedure or surgery | 2. Intervention |
Primary outcome
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.
Change in quadriceps muscle thickness
14 secondary outcomes
MRC-ss
Time frame: On discharge from ICU, up to 1 year from recruitment.
MRC-ss
Time frame: 14 days after recruitment
MRC-ss
Time frame: On discharge from hospital, up to 1 year from recruitment.
FSS-ICU
Time frame: On discharge from ICU, up to 1 year from recruitment.
FSS-ICU
Time frame: 14 days after recruitment
FSS-ICU
Time frame: On discharge from hospital, up to 1 year from recruitment.
CPax
Time frame: On discharge from ICU, up to 1 year from recruitment.
CPax
Time frame: 14 days after recruitment
CPax
Time frame: On discharge from hospital, up to 1 year from recruitment.
Quadriceps strength and hand grip strength
Time frame: On discharge from ICU, up to 1 year from recruitment.
Quadriceps strength and hand grip strength
Time frame: 14 days after recruitment
Quadriceps strength and hand grip strength
Time frame: On discharge from hospital, up to 1 year from recruitment.
Length of Stay in ICU
Time frame: Day of discharge from ICU, up to 1 year from recruitment.
Length of hospital stay
Time frame: Day of discharge from hospital, up to 1 year from recruitment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 24108501Puthucheary 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.
- Background: PubMed 25855901Wei 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.
- Background: PubMed 25610953Wichansawakun 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.
- Background: PubMed 28978333Parry 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.
- Background: PubMed 17418917Reid 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.
- Background: PubMed 21340655Singer 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.
- Background: PubMed 28030555Kho 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.
- Background: PubMed 19158125Seymour 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.
- Background: PubMed 11534564Petros 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.
- Derived from this study: PubMed 38714926Elizabeth 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Will NH Loh, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry directed feeding. and Cycle Ergometry in people with Calorimetry, Indirect and Exercise Therapy, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540732, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.