Actigraphy to MEasuRe Intensive Care Unit Activity

Aging Clinical Trial

— AMERICA  

Official title:

Actigraphy to MEasuRe Intensive Care Unit Activity (AMERICA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263716
• Other study ID #: 141504
• 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

• Aging
• Critical Illness
• Disability
• Physical Activity

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