FrailtyIMPACTNCT04717869
Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
An observational study of Frailty and Sarcopenia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Frailty, the decline in physical and cognitive reserves leading to vulnerability to stressors is increasingly being recognized as a public health concern. Although multiple measures exist that can identify frail patients, very little is known about how or when to intervene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- Ultrasound, Biomarker Analysis and Frailty Index
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the the Surgical, Cardiothoracic, or Neuro ICU.
Who may be able to join
- Adult patients admitted to the Surgical, Cardiothoracic or Neuro ICU
- ICU stay longer than 24 hours
Who cannot join
- Patients with muscular or mitochondrial diseases affecting muscle quality or mass
- Preexisting paralysis
- Absence of lower limbs
- Ongoing discussions about goals of care
- Transfers from a skilled nursing facility
- Children under the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, 90095
Jennifer Scovotti, MA, 3102064484, jscovotti@mednet.ucla.edu
Cecilia Canales, MD, MPH
About this study
Official title: Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study
Frailty, the decline in physical and cognitive reserves leading to vulnerability to stressors is increasingly being recognized as a public health concern. Although multiple measures exist that can identify frail patients, very little is known about how or when to intervene. Sarcopenia, or the degree of muscle wasting, is closely correlated to frailty and patient outcomes. This is a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia, as potential targets to reduce frailty.
Read the detailed description
Frailty is the decline in physical and cognitive reserves leading to increased vulnerability to stressors such as surgery or disease states. Frailty is not a disease, but a syndrome with a distinct frail phenotype that includes decreased status in mobility, muscle mass, nutritional status, strength, and endurance. Frail patients are at greater risk of adverse outcomes, such as functional decline, prolonged hospitalization with associated increases in healthcare costs and death. Multiple measures of frailty exist and although they are important for understanding risk for a given patient population or resource utilization, they do not provide any insight as to how to manage or treat frail patients.
In critically ill patients, sarcopenia has long been tied to poor outcomes, poor nutrition status, and decreased ability to perform activities of daily living (ADLs). We hypothesize that sarcopenia as a marker for frailty in critically ill patients can be used to track development and recovery of frailty.
The objective of this proposal to create a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia as potential targets for therapeutic measures to improve or reverse frailty.
The primary aim of the study is to track sarcopenia in critically ill patients. Sarcopenia is a measure of frailty and is associated with worse outcomes in critically ill patients. The aim to understand how the kinetics of sarcopenia differ in critically ill population given the heterogeneity of with various disease process which may affect the degree and rate of muscle wasting. Understanding the disease process is important in identifying when or how to intervene to obtain meaningful recovery.
Secondary aims are to assess the role biomarkers in patients across the frailty spectrum to understand their role frailty. Additionally nutrition is well known to affect sarcopenia and nutritional status is a key component in frailty. Nutrition status will be tracked to understand development of sarcopenia.
- Conditions
- Frailty, Sarcopenia
- Being tested
- Ultrasound, Biomarker Analysis, Frailty Index
- Keywords
- Frailty, Sarcopenia, Ultrasound
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
2D ultrasound image collection
Biomarker AnalysisDiagnostic test
Inflammatory and nutritional biomarker analysis
Frailty IndexOther
Also called Questionnaire
A Frailty Index Questionnaire be completed by patients or their surrogates to determine the presence of frailty at ICU admission
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients | Adult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Biomarker Analysis; Other: Frailty Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge Disposition
Disposition of patient at time of hospital discharge, home, rehabilitation or skilled nursing facility, in hospital death
Measured: Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months
Length of ICU stay
Length of time patient is admitted to ICU until transfer out of the ICU
Measured: Patients will be followed from enrollment to ICU transfer. Approximately 2 weeks to 2 months
Length of Hospital stay
Length of time patient is admitted to the hospital including length of time patient spends in the ICU until discharge or death
Measured: Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months
Secondary outcomes (1)
Adverse Events
Falls, fractures, number of emergency room visits, number of times hospitalized, total hospital days and mortality
Measured: Patients will be followed from enrollment to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start22 Sep 2023
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Canales, University of California, Los Angeles
- Investigators
- Cecilia Canales, MD, MPH, Principal investigator, UCLA Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717869
- Sponsor's protocol ID
- 20-002271
- Acronym
- IMPACT
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared outside the study team.
Publications
Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.
PubMed 31609228Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.
PubMed 21093718Op het Veld LP, van Rossum E, Kempen GI, de Vet HC, Hajema K, Beurskens AJ. Fried phenotype of frailty: cross-sectional comparison of three frailty stages on various health domains. BMC Geriatr. 2015 Jul 9;15:77. doi: 10.1186/s12877-015-0078-0.
PubMed 26155837Ritt M, Schwarz C, Kronawitter V, Delinic A, Bollheimer LC, Gassmann KG, Sieber CC. Analysis of Rockwood et Al's Clinical Frailty Scale and Fried et Al's Frailty Phenotype as Predictors of Mortality and Other Clinical Outcomes in Older Patients Who Were Admitted to a Geriatric Ward. J Nutr Health Aging. 2015 Dec;19(10):1043-8. doi: 10.1007/s12603-015-0667-9.
PubMed 26624218Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Zylberglait Lisigurski M, Bueno YA, Karanam C, Andrade AD, Akkineni S, Cevallos V, Ruiz JG. Healthcare Utilization by Frail, Community-Dwelling Older Veterans: A 1-Year Follow-up Study. South Med J. 2017 Nov;110(11):699-704. doi: 10.14423/SMJ.0000000000000722.
PubMed 29100219Eamer G, Gibson JA, Gillis C, Hsu AT, Krawczyk M, MacDonald E, Whitlock R, Khadaroo RG. Surgical frailty assessment: a missed opportunity. BMC Anesthesiol. 2017 Jul 24;17(1):99. doi: 10.1186/s12871-017-0390-7.
PubMed 28738809Lim WS, Wong SF, Leong I, Choo P, Pang WS. Forging a Frailty-Ready Healthcare System to Meet Population Ageing. Int J Environ Res Public Health. 2017 Nov 24;14(12):1448. doi: 10.3390/ijerph14121448.
PubMed 29186782Hastings SN, Purser JL, Johnson KS, Sloane RJ, Whitson HE. Frailty predicts some but not all adverse outcomes in older adults discharged from the emergency department. J Am Geriatr Soc. 2008 Sep;56(9):1651-7. doi: 10.1111/j.1532-5415.2008.01840.x. Epub 2008 Aug 4.
PubMed 18691282Lin H, Peel NM, Scott IA, Vardesh DL, Sivalingam P, McBride RL, Morong JJ, Nelson MJ, Hubbard RE. Perioperative assessment of older surgical patients using a frailty index-feasibility and association with adverse post-operative outcomes. Anaesth Intensive Care. 2017 Nov;45(6):676-682. doi: 10.1177/0310057X1704500605.
PubMed 29137576Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr. 2016 Aug 31;16(1):157. doi: 10.1186/s12877-016-0329-8.
PubMed 27580947Robinson TN, Wu DS, Pointer L, Dunn CL, Cleveland JC Jr, Moss M. Simple frailty score predicts postoperative complications across surgical specialties. Am J Surg. 2013 Oct;206(4):544-50. doi: 10.1016/j.amjsurg.2013.03.012. Epub 2013 Jul 20.
PubMed 23880071Smart R, Carter B, McGovern J, Luckman S, Connelly A, Hewitt J, Quasim T, Moug S. Frailty Exists in Younger Adults Admitted as Surgical Emergency Leading to Adverse Outcomes. J Frailty Aging. 2017;6(4):219-223. doi: 10.14283/jfa.2017.28.
PubMed 29165541Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Amrock LG, Neuman MD, Lin HM, Deiner S. Can routine preoperative data predict adverse outcomes in the elderly? Development and validation of a simple risk model incorporating a chart-derived frailty score. J Am Coll Surg. 2014 Oct;219(4):684-94. doi: 10.1016/j.jamcollsurg.2014.04.018. Epub 2014 Jun 3.
PubMed 25154667
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04717869
- Acronym / sponsor ID
- IMPACT / 20-002271
- Conditions
- Frailty, Sarcopenia
- Keywords
- Frailty, Sarcopenia, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Jan 2021 (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.
Frailty, the decline in physical and cognitive reserves leading to vulnerability to stressors is increasingly being recognized as a public health concern. Although multiple measures exist that can identify frail patients, very little is known about how or when to intervene. Sarcopenia, or the degree of muscle wasting, is closely correlated to frailty and patient outcomes. This is a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia, as potential targets to reduce frailty.
Detailed description
Frailty is the decline in physical and cognitive reserves leading to increased vulnerability to stressors such as surgery or disease states. Frailty is not a disease, but a syndrome with a distinct frail phenotype that includes decreased status in mobility, muscle mass, nutritional status, strength, and endurance. Frail patients are at greater risk of adverse outcomes, such as functional decline, prolonged hospitalization with associated increases in healthcare costs and death. Multiple measures of frailty exist and although they are important for understanding risk for a given patient population or resource utilization, they do not provide any insight as to how to manage or treat frail patients.
In critically ill patients, sarcopenia has long been tied to poor outcomes, poor nutrition status, and decreased ability to perform activities of daily living (ADLs). We hypothesize that sarcopenia as a marker for frailty in critically ill patients can be used to track development and recovery of frailty.
The objective of this proposal to create a prospective cohort study of critically ill patients to identify modifiable risk factors of sarcopenia as potential targets for therapeutic measures to improve or reverse frailty.
The primary aim of the study is to track sarcopenia in critically ill patients. Sarcopenia is a measure of frailty and is associated with worse outcomes in critically ill patients. The aim to understand how the kinetics of sarcopenia differ in critically ill population given the heterogeneity of with various disease process which may affect the degree and rate of muscle wasting. Understanding the disease process is important in identifying when or how to intervene to obtain meaningful recovery.
Secondary aims are to assess the role biomarkers in patients across the frailty spectrum to understand their role frailty. Additionally nutrition is well known to affect sarcopenia and nutritional status is a key component in frailty. Nutrition status will be tracked to understand development of sarcopenia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients | – | Diagnostic Test: Ultrasound, Diagnostic Test: Biomarker Analysis, Other: Frailty IndexAdult Surgical, Cardiothoracic, and Neuro- ICU patients will be enrolled within 48 hrs of admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the the Surgical, Cardiothoracic, or Neuro ICU.
Key inclusion criteria (2 listed)
- Adult patients admitted to the Surgical, Cardiothoracic or Neuro ICU
- ICU stay longer than 24 hours
Key exclusion criteria (6 listed)
- Patients with muscular or mitochondrial diseases affecting muscle quality or mass
- Preexisting paralysis
- Absence of lower limbs
- Ongoing discussions about goals of care
- Transfers from a skilled nursing facility
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 |
|---|---|---|
| Ultrasound2D ultrasound image collection | Diagnostic test | ICU Patients |
| Biomarker AnalysisInflammatory and nutritional biomarker analysis | Diagnostic test | ICU Patients |
| Frailty IndexAlso: QuestionnaireA Frailty Index Questionnaire be completed by patients or their surrogates to determine the presence of frailty at ICU admission | Other | ICU Patients |
Primary outcome
Discharge Disposition
Time frame: Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months
Disposition of patient at time of hospital discharge, home, rehabilitation or skilled nursing facility, in hospital death
Length of ICU stay
Time frame: Patients will be followed from enrollment to ICU transfer. Approximately 2 weeks to 2 months
Length of time patient is admitted to ICU until transfer out of the ICU
Length of Hospital stay
Time frame: Patients will be followed from enrollment until discharge from the hospital. Approximately 2 weeks to 2 months
Length of time patient is admitted to the hospital including length of time patient spends in the ICU until discharge or death
1 secondary outcome
Adverse Events
Time frame: Patients will be followed from enrollment to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 31609228Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.
- Background: PubMed 21093718Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.
- Background: PubMed 26155837Op het Veld LP, van Rossum E, Kempen GI, de Vet HC, Hajema K, Beurskens AJ. Fried phenotype of frailty: cross-sectional comparison of three frailty stages on various health domains. BMC Geriatr. 2015 Jul 9;15:77. doi: 10.1186/s12877-015-0078-0.
- Background: PubMed 26624218Ritt M, Schwarz C, Kronawitter V, Delinic A, Bollheimer LC, Gassmann KG, Sieber CC. Analysis of Rockwood et Al's Clinical Frailty Scale and Fried et Al's Frailty Phenotype as Predictors of Mortality and Other Clinical Outcomes in Older Patients Who Were Admitted to a Geriatric Ward. J Nutr Health Aging. 2015 Dec;19(10):1043-8. doi: 10.1007/s12603-015-0667-9.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Background: PubMed 29100219Zylberglait Lisigurski M, Bueno YA, Karanam C, Andrade AD, Akkineni S, Cevallos V, Ruiz JG. Healthcare Utilization by Frail, Community-Dwelling Older Veterans: A 1-Year Follow-up Study. South Med J. 2017 Nov;110(11):699-704. doi: 10.14423/SMJ.0000000000000722.
- Background: PubMed 28738809Eamer G, Gibson JA, Gillis C, Hsu AT, Krawczyk M, MacDonald E, Whitlock R, Khadaroo RG. Surgical frailty assessment: a missed opportunity. BMC Anesthesiol. 2017 Jul 24;17(1):99. doi: 10.1186/s12871-017-0390-7.
- Background: PubMed 29186782Lim WS, Wong SF, Leong I, Choo P, Pang WS. Forging a Frailty-Ready Healthcare System to Meet Population Ageing. Int J Environ Res Public Health. 2017 Nov 24;14(12):1448. doi: 10.3390/ijerph14121448.
- Background: PubMed 18691282Hastings SN, Purser JL, Johnson KS, Sloane RJ, Whitson HE. Frailty predicts some but not all adverse outcomes in older adults discharged from the emergency department. J Am Geriatr Soc. 2008 Sep;56(9):1651-7. doi: 10.1111/j.1532-5415.2008.01840.x. Epub 2008 Aug 4.
- Background: PubMed 29137576Lin H, Peel NM, Scott IA, Vardesh DL, Sivalingam P, McBride RL, Morong JJ, Nelson MJ, Hubbard RE. Perioperative assessment of older surgical patients using a frailty index-feasibility and association with adverse post-operative outcomes. Anaesth Intensive Care. 2017 Nov;45(6):676-682. doi: 10.1177/0310057X1704500605.
- Background: PubMed 27580947Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr. 2016 Aug 31;16(1):157. doi: 10.1186/s12877-016-0329-8.
- Background: PubMed 23880071Robinson TN, Wu DS, Pointer L, Dunn CL, Cleveland JC Jr, Moss M. Simple frailty score predicts postoperative complications across surgical specialties. Am J Surg. 2013 Oct;206(4):544-50. doi: 10.1016/j.amjsurg.2013.03.012. Epub 2013 Jul 20.
- Individual participant dataSharing planned: No. The data will not be shared outside the study team.
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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.
Cecilia Canales, MD, MPH principal investigator
UCLA Department of Anesthesiology and Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Sarcopenia, run by University of California, Los Angeles at 1 site in United States.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Scovotti, MA (3102064484, jscovotti@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge Disposition (time frame: Patients will be followed from enrollment to hospital discharge. Approximately 2 weeks to 2 months). The study lists 3 primary outcomes in all. 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 NCT04717869, which also lists 29 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 30 Jan 2026.