Actigraphy to MEasuRe Intensive Care Unit Activity

NCT02263716 | Completed

• 1 other identifier: 141504
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability; Physical Activity; Aging; Critical Illness

Keywords

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

Outcome Measures

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.

  1 Day

Secondary Outcomes (1)

• Tolerability of accelerometry devices.

  1 Day

Study Arms (1)

Accelerometer

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients will be included if they are:
• adult patients,
• admitted to the medical or surgical ICU,
• 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
• who are receiving routine physical and occupational therapy.

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Those who have severe physical disability that prevented independent living prior to their illness,
• Those unable to speak and communicate in English,
• 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),
• Inability to obtain informed consent from authorized surrogate;

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Motor Activity; Critical Illness; Delirium; Sepsis

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Nathan E. Brummel, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 13, 2014
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

US (1)