Clinical trial NCT02263716: Actigraphy to MEasuRe Intensive Care Unit Activity
Official title: Actigraphy to MEasuRe Intensive Care Unit Activity (AMERICA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disability
Physical Activity
Aging
Critical Illness
Keywords: Physical Activity
Intensive Care
Activities of Daily Living
Delirium
Sepsis
Mechanical Ventilation
Critical Care
Critical Illness
Aging
Accelerometery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A diverse population of adult patients with medical or surgical critical illness in the ICU.

Brief summary: This study is to determine whether accelerometry can be used to measure physical activity occurring during routine clinical care in a diverse population of patients with medical or surgical critical illness.

Detailed description: Patients that meet inclusion criteria will have a wristwatch size, lightweight ActiGraph GT3X+ placed at each of three body sites, the dominant-side wrist, right hip and dominant-side ankle to objectively measure physical activity. Patients will wear the ActiGraph devices during two 30-minute periods of direct observation. To compare activity counts measured by the ActiGraph devices with directly observed purposeful physical activity, we will record the time and type of physical activity performed by patients such as sitting at the edge of the bed, sitting in a bedside chair, transferring to a chair, standing and ambulating. The data acquired from this observational (AMERCIA) study will seek to establish the feasibility of using accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.

Eligibility criteria: Inclusion Criteria:

Patients will be included if they are:

1. adult patients,
2. admitted to the medical or surgical ICU,
3. receiving or have received invasive or non-invasive mechanical ventilation for respiratory failure or vasopressors for shock (i.e., cardiogenic, hemorrhagic, septic or undifferentiated shock) within the last 48 hours, and
4. who are receiving routine physical and occupational therapy.

Exclusion Criteria:

Patients will be excluded if they meet any of the following criteria:

1. Those who have severe physical disability that prevented independent living prior to their illness,
2. Those unable to speak and communicate in English,
3. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by the family or medical team (i.e., likely to withdraw life support measures within 24 hours of screening),
4. Inability to obtain informed consent from authorized surrogate;

Primary outcomes:
measure: Feasibility of accelerometers to measure physical activity in patients with a critical illness.
timeFrame: 1 Day
Secondary outcomes:
measure: Tolerability of accelerometry devices.
timeFrame: 1 Day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Nathan E. Brummel, MD
role: PRINCIPAL_INVESTIGATOR
References: