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Actigraphy to MEasuRe Intensive Care Unit Activity

Actigraphy to MEasuRe Intensive Care Unit Activity (AMERICA)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02263716
Acronym
AMERICA
Enrollment
25
Registered
2014-10-13
Start date
2015-07-31
Completion date
2016-02-29
Last updated
2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Critical Illness, Disability, Physical Activity

Keywords

Physical Activity, Intensive Care, Activities of Daily Living, Delirium, Sepsis, Mechanical Ventilation, Critical Care, Critical Illness, Aging, Accelerometery

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.

Interventions

None listed

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of accelerometers to measure physical activity in patients with a critical illness.1 DayTo determine the validity of activity counts from each of the three accelerometry sites (wrist, hip and ankle) with direct observation acting as the reference.

Secondary

MeasureTime frameDescription
Tolerability of accelerometry devices.1 DayWe will assess tolerability of the ActiGraph devices through the assessment of the number of total hours devices are worn (out of 120 hours of possible measurement time). We will record the time of device removal and replacement as well as reasons for device removal. Patients will be routinely evaluated for device-related discomfort and devices will be repositioned or removed accordingly. Finally, at the conclusion of the study period, patients will be surveyed regarding the tolerability of the devices.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026