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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263716
Other study ID # 141504
Secondary ID
Status Completed
Phase N/A
First received October 2, 2014
Last updated January 4, 2017
Start date July 2015
Est. completion date February 2016

Study information

Verified date January 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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