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CompletedNCT02263716AMERICAUpdated Jan 6, 2017

Actigraphy to MEasuRe Intensive Care Unit Activity

An observational study in Disability, Physical Activity and Aging, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Vanderbilt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Disability
  • Physical Activity
  • Aging
  • Critical Illness

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Keywords

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

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 25 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A diverse population of adult patients with medical or surgical critical illness in the ICU.

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

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;
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Accelerometer

    Utilize accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.

06

What researchers measure

Primary outcomes

  1. Feasibility of accelerometers to measure physical activity in patients with a critical illness.

    To determine the validity of activity counts from each of the three accelerometry sites (wrist, hip and ankle) with direct observation acting as the reference.

    Time frame: 1 Day

Secondary outcomes

  1. Tolerability of accelerometry devices.

    We 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.

    Time frame: 1 Day

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Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02263716
Lead sponsor
Vanderbilt University
Responsible party
Nathan Brummel (Instructor in Medicine, Vanderbilt University) — Principal investigator
First posted
Oct 13, 2014
Start date
Jul 2015
Primary completion
Jan 2016
Completion
Feb 2016
Last update
Jan 6, 2017

Study contacts

Nathan E. Brummel, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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