Actigraphy to MEasuRe Intensive Care Unit Activity (AMERICA)

Actigraphy to MEasuRe Intensive Care Unit Activity (AMERICA)

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Physical Activity; Aging; Disability

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Accelerometer; Utilize accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Nathan E. Brummel, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity; Aging; Sepsis; Critical Illness; Mechanical Ventilation; Activities of Daily Living; Intensive Care; Critical Care; Delirium; Accelerometery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 141504