Patient Ambulation in Post-Op Recovery

Physical Activity Clinical Trial

Official title:

Measuring Patient Ambulation in Post-Operative Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528669
• Other study ID #: 1024875
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: October 13, 2017
• Start date: July 23, 2014
• Est. completion date: October 10, 2016

Study information

• Verified date: May 2015
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital.

Description:

Early ambulation in post-operative patients has shown benefits including shorter length of stay and/or fewer complications. Accelerometers have been found as useful instruments in encouraging ambulation in patients. Accelerometers are non-invasive devices that can evaluate changes in movement, gait, and ambulatory activity. Although these devices can be beneficial, little research exists on the best way to engage patients in ambulation, how to develop a standard ambulation protocol, and the best algorithms to measure ambulation post-operation. This study seeks to develop a standardized activity tracker and program that will encourage patient ambulation and allow patients and healthcare providers to view the progress of daily walking goals.

A total of 3,000 patients will be asked if they would like to participate in this study. A healthcare provider will explain to the patient the benefits of getting out of bed, sitting, and walking after an invasive procedure. Patients who decide to participate will be given an accelerometer during their pre-operation visit or after their surgery while still in the hospital. Patients will be asked to wear the accelerometer continuously during waking hours. The accelerometer will provide patients with daily walking goals, reminders of when it is time to walk, track step count, record time of walk, and duration of walk. Patients will be asked to wear the accelerometer until their post-op visit (about 30 days).

The following data points will be analyzed:

• Relationship between ambulation and patient outcomes

• Relationship between ambulation and other health factors

• Effectiveness of prototype platform to motivate and monitor patient activity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 10, 2016
• Est. primary completion date: October 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of physician study investigators

Exclusion Criteria:

• Patients whose physicians find they are unfit to participate in a walking program

Related Conditions & MeSH terms

• Physical Activity

Intervention

Device:
• RX Navigait
The RX Navigait is an accelerometer that tracks the number to steps taken, duration of walking, and time of walking. In addition, this device sends messages to patients regarding daily walking goals and walking reminders.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Savvysherpa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Ambulation (number of steps, frequency, time)		Up to 3 months
Secondary	Accuracy of accelerometer algorithms measuring post operation walking		Up to three years
Secondary	Number of patients completing ambulation program		Up to three years