910 Use of ActiGraph Activity Monitor

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) ensures the proper use and operation of activity monitors with research participants. The activity monitor can be used to measure and record physical movement, heart rate, and ambient light levels associated with daily activity and sleep. Attachment templates included:

A: ActiGraph Inventory Log

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Definitions

ActiGraph: A non-invasive method of monitoring human rest/activity cycles.

Procedures

1. Setup

• Prior to deploying the devices, they should be connected via USB cable to a computer with ActiLife software installed. Parameters should be set to protocol specifications and verify the device is fully charged.

2. Deployment of Waist Worn Devices

• Remove the clip at one end of the elastic waist belt. Thread the belt through the wings on each side of the wGT3X-BT so the belt lies flat against the back side of the device. Replace the clip and adjust the length as needed.
• The subject should be instructed to fasten the belt snugly around the waist and position the wGT3X-BT approximately in line with the armpit and knee with the USB port cover facing up.

3. Deployment of Wrist Worn Devices

• Insert the thin end of the wrist strap into one of the wGT3X-BT wings with the Velcro side facing out. Pull until the thick end of the strap catches in the wing. Insert the thin end into the opposite wing to create a loop. The strap should not cover the back of the device.
• The subject should be instructed to wear the device strapped securely to the non-dominant wrist with the logo facing up when viewed like a wristwatch. The strap is secured and adjusted by folding excess length outward and fastening to the Velcro.

4. Heart Rate Monitor Deployment

• Ensure that the ‘Heart Rate’ option is enabled during initialization of the wGT3X-BT.
• Moistening the skin facing side of the device is recommended to ensure a strong signal.
• Unsnap the heart rate transmitter from the chest strap, position the transmitter in the center of the sternum, and snap back into place.
• Adjust the strap so it is secure across the breastbone. Data will automatically be collected when in range of the wGT3X-BT.

5. Data Storage

• When data collection is complete, connect the device via USB cable to a computer with ActiLife software installed. Download the data files and store them in the appropriate location.

6. Inventory

• Devices should be signed out on Attachment A: ActiGraph Inventory Log prior to deployment. Devices should be signed in on the same log upon return.

7. Cleaning & Maintenance

• The wGT3X-BT should be cleaned with an alcohol-based solution after each deployment.
• The heart rate monitor should be cleaned with an alcohol-based solution after each deployment.
• Belts and wrist straps should be laundered.
• Charge the battery via USB port by unscrewing the cover with the triangle tool and connecting it to a PC or charging hub. When fully charged, the green LED is lit continuously.

8. Informed Consent Language

You will be fitted with an activity monitor that will measure your physical activity and sleep. You will be asked to wear the device on an elastic band around your waist/wrist/ankle for (insert time frame). You will remove the monitor for bathing/swimming activity.

Risks: There may be slight discomfort or the feeling of inconvenience when wearing the device. The belt should be worn over clothes to avoid skin irritation.

References: User Guide ActiGraph wGT3X-BT + ActiLife

Attachments: A: ActiGraph Inventory Log

Appendices: None

Approver: Director, CTRU and Clinical Partnerships

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