Measuring Outcomes of Activity in Intensive Care

Running, not enrolling

Conditions studied: Critical Illness, Sepsis, Mechanical Ventilation, Physical Activity, Disability Physical, Muscle Weakness, Cognitive Impairment

In brief

Millions of older adults are hospitalized for a critical illness each year and although they are more likely than ever to survive this illness, they commonly face significant morbidity in the form of disabilities in basic self-care activities and in mobility in the months and years afterwards. A better understanding of the underlying risk factors for disability following critical illness is greatly needed, including the effect that activity during hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between activity (measured more rigorously than in prior investigations) and disability, physical function, and cognitive function in survivors of critical illness 3 and 12 months after ICU discharge.

Key facts

Study ID

NCT03115840

Run by

Vanderbilt University Medical Center

People needed

312

Starts

2017-03-27

Expected to finish

2030-12-31

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients (≥18 years old),
• in a medical or surgical ICU at Vanderbilt University Medical Center or The Ohio State University Medical Center, and
• are being treated for respiratory failure or shock.

You may not qualify if…

• Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment, such that the patient will no longer meet inclusion criteria.
• Cumulative hospital days (ICU plus non-ICU) of five or greater in the last 30 days prior to meeting all inclusion criteria.
• Inability to live independently at baseline due to acquired or congenital disabling, physical, cognitive or mental health disorder requiring institutionalization (e.g., nursing home, skilled nursing facility, group home, long-term acute care hospital, rehab facility) or any patient who resides outside an institution with an inability to walk without the assistance of another person (e.g., patients with quadriplegia, paraplegia, double amputees, those with residual paralysis from stroke).
• Acute or subacute severe neurologic (e.g., stroke anoxic injury, spinal cord injury) that is expected to prevent the patient from living independently after hospital discharge.
• Body mass index >50
• Active substance abuse or psychotic disorder (e.g., schizophrenia or schizo-affective disorder), recent (within the past 6 months) serious suicidal gesture necessitating hospitalization
• Blindness, deafness, or inability to understand English that will preclude follow-up evaluation. Patients with laryngectomies and those with hearing impairments are eligible for enrollment if their medical condition permits them to communicate with research staff.
• Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of screening).
• Prisoners
• Patients who live further than 200 miles from an enrolling center and who do not regularly visit the area.
• Patients who are homeless and have no secondary contact person available
• Current enrollment in a study that does not allow co-enrollment
• Inability to obtain informed consent from the patient or an authorized representative within 72 hours of meeting all inclusion criteria for the following reasons:
• Attending physician refusal
• Patient and/or surrogate refusal
• 72-hour period of eligibility was exceeded before the patient was screened
• Patient unable to consent and no surrogate available within 72 hours of meeting all inclusion criteria
• Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Where it is running

• The Ohio State University Medical Center — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.