Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04717869

Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Cecilia Canales, MD, MPH

PRINCIPAL_INVESTIGATOR

Jennifer Scovotti, MA

CONTACT

[email protected]

3102064484

Maxime Cannesson, MD, Ph.D

SUB_INVESTIGATOR

Sumit Singh, MD

SUB_INVESTIGATOR

Vadim Gudzenko, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients admitted to the Surgical, Cardiothoracic or Neuro ICU
  • ICU stay longer than 24 hours

Exclusion criteria

  • 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

Treatment and study plan

Ultrasound

Diagnostic Test

2D ultrasound image collection

biomarker analysis

Diagnostic Test

Inflammatory and nutritional biomarker analysis

Frailty Index

Other

A Frailty Index Questionnaire be completed by patients or their surrogates to determine the presence of frailty at ICU admission

Other names: Questionnaire

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Adverse Events

    Time frame: Patients will be followed from enrollment to 1 year.

    Falls, fractures, number of emergency room visits, number of times hospitalized, total hospital days and mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Scovotti, MA

CONTACT

[email protected]

3102064484

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Identifying Modifiable PAtient Centered Therapeutics Frailty: An Observational Cohort Study

Acronym: IMPACT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.