Post-Operative Physical Activity Monitoring: Algorithm Performance and Clinical Outcomes

NCT06605066 | Completed

• 1 other identifier: AIBU-FTR-AO-02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to validate physical activity algorithms in post-operative populations through raw accelerometer data collection using the ADI Study Watch 4.5 while in an in-patient setting. The secondary objective of the study is to collect skin temperature, photoplethysmography \[PPG\], Bioimpedance Analysis \[BIA\], heart rate \[HR\], SpO2, and electrodermal activity \[EDA\] using the ADI Study Watch 4.5. The main questions it aims to answer are:

• Can a wearable physical activity monitoring device assess patients\' activity levels with higher accuracy and precision compared to traditional physical activity monitoring methods during the post-operative period?
• Do wearable devices placed on different body regions perform similarly in tracking physical activity during the post-operative period?
• Do post-operative physical activity monitoring algorithms improve patient compliance, accelerate recovery, and reduce hospital stay duration?
• Analysis of the activity tracking performance of a consumer device (Apple Watch) in patients after cardiac and thoracic surgery.

Conditions

Postoperative Period; Physical Activity; Wearable Electronic Devices; Algorithms; Thoracic Surgery; Cardiac Surgery

Keywords

Postoperative Period; Physical Activity; Wearable Electronic Devices; Algorithms; Thoracic Surgery; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Raw Accelerometer Data

  Accelerometers measure linear acceleration (specified in mV/g) along one or several axis. ADI Study Watch 4.5 and Axivity AX6 devices have a three-axis accelerometer, which delivers acceleration values in each of the three axes. The values reported by the accelerometers are measured in increments of the gravitational acceleration, with the value 1.0 representing an acceleration of 9.8 meters per second (per second) in the given direction. Acceleration values may be positive or negative depending on the direction of the acceleration. Raw accelerometer data will be used to validate step count, distance and activity level algorithms. Measurements will be made with ADI Study Watch 4.5 and Axivity AX6.

  Within 3 days after the patient is discharged to the inpatient setting, data will be collected from each individual once for a duration of 5 hours using wearable devices.

Secondary Outcomes (14)

• International Physical Activity Questionnaire (Short Form)

  Once during the study period, within 3 days after the patient is discharged to the inpatient setting.

• Six Minute Walk Test

  Once during the study period, within 3 days after the patient is discharged to the inpatient setting.

• Visual Analogue Scale (VAS)

  Once during the study period, within 3 days after the patient is discharged to the inpatient setting.

• TAMPA Kinesiophobia Scale

  Once during the study period, within 3 days after the patient is discharged to the inpatient setting.

• ASA Physical Status Classification System

  Once during the study period, within 3 days after the patient is discharged to the inpatient setting.

Study Arms (1)

Post-Operative

Adults aged 18 and over who have undergone cardiac or thoracic surgery, been discharged from the post-anesthesia care unit, and transferred to an inpatient setting within 3 days prior to the data collection date.

Eligibility Criteria

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

Study Population

Individuals who meet the inclusion criteria and have undergone Cardiovascular or Thoracic surgery at Izzet Baysal Training and Research Hospital will be included in the study. Individuals will be included in the study according to the simple random sampling method.

You may qualify if:

• Age ≥ 18, male or female
• ASA Score II - III
• Patients booked for a surgical procedure requiring general anesthesia care
• The subject has had a surgical procedure ≤3 days prior to data collection
• Expected duration of general anesthesia to be \> 1 hour
• Expected to be transferred to the PACU from the operating room
• Patients with an expected duration in the PACU ≥ 45 minutes
• Expected to be transferred from the PACU to an in-patient setting
• Must be able to understand and provide written consent
• Must be willing and able to comply with study procedures and duration

You may not qualify if:

• The subject is unable or unwilling to provide written consent
• The subject is unable or unwilling to comply with the study and duration
• The subject has not yet recovered from the effects of anesthesia
• The subject requires the use of a wheel chair
• The subject has been diagnosed with a movement disorder such as Parkinson's disease, ataxia, dystonia, etc.
• The subject has not yet recovered from knee or hip surgery
• The subject has undergone orthopedic surgery within the last 2 years
• The subject has an injury, deformity, or abnormality at the sensor site that in the opinion of the investigators would interfere with the sensors' function
• The subject has any other condition, which in the opinion of the investigator would make them unsuitable for the study
• The subject is pregnant, lactating, or trying to get pregnant.
• Subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found medical tape.

Sponsors & Collaborators

• Alp Ozel: lead
• Analog Device, Inc.: collaborator

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 20, 2024
• Study Start: October 9, 2024
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

TU (1)