Actigraphy to MEasuRe Intensive Care Unit Activity

Completed

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

• Registration Number: NCT02263716
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-13
• Study Start: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of accelerometers to measure physical activity in patients with a critical illness.	1 Day	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.

Secondary Outcome Measures

Name	Time	Method
Tolerability of accelerometry devices.	1 Day	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States