Physical Activity Measure Application (MARCHE)

Evaluation of an Application Allowing Physical Activity to Get Information on Their Physical Activity in the First Days Following Thoracic Surgery

Although there is a strong physiological rationale for the benefit of post-operative mobilization, the evidence supporting these effects in surgical cohorts is conflicting, and there is a lack of research to guide the clinical implementation of early mobilization protocols. There is also a need to better evaluate the physical activity performed by physical activity tients outside the supervised mobilization protocol, to better understand its potential benefits on post-operative recovery. In adition, the objective measurement of physical activity has several advantages over declarative measures.

Study Overview

• Status: Completed
• Conditions: Physical Inactivity; Post-Surgical Complication
• Intervention / Treatment: Device: Physical activity measure

Detailed Description

Prolonged immobilization after surgery is known to have detrimental effects. Although postoperative recommendations favor early mobilization, the lack of quantification of physical activity poses a problem for the implementation of early mobilization protocols..

An application named "ACTIM" has been developed with the aim of automating the personalized assessment of postoperative physical activity. The healthcare team (nurses or physiotherapists…), will share the information with the patient and will complete the assessment using personalized physical activity objectives for the day.

The purpose of this study is to assess this application in real-life settings to provide patients with information on their physical activity after lung resection by thoracoscopy or robotic surgery. This assessment will serve as a reference for future studies.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Foch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient 18 years of age or older
• Scheduled for thoracoscopic or robotic lung resection
• Agreeing to wear an ActiGraph GT3X accelerometer from 4 days post-surgery
• Having signed a consent form
• Affiliated with a health insurance

Exclusion Criteria:

• Pregnant or breastfeeding woman
• Patient unable to move independently (paraplegic, etc.)
• Patient deprived of liberty or under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GT3X ActiGraph's activity monitor; Patients who have undergone thoracic surgery wearing an ActiGraph GT3X-BT device that measures and records physical movement associated with daily activity.	Device: Physical activity measure; After surgery, patients patients will be fitted with GT3X ActiGraph's activity monitor to capture and record continuous physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the agreement between ACTIM application and Actilife Softawre for the sitting-lying position	Measure, from postoperative Day 1 up to Day 4 of time spent sitting/lying-down	up to 4 days
Assess the agreement between ACTIM application and Actilife Softawre for sitting-standing transition	Measure, from postoperative Day 1 up to Day 4 of number of sit-to-stand transitions	up to 4 days
Assess the agreement between ACTIM application and Actilife Softawre for step count	Measure, from postoperative Day 1 up to Day 4 of number of number of steps	up to 4 days
Assess the agreement between ACTIM application and Actilife Softawre for walking pace	Measure, from postoperative Day 1 up to Day 4 of number of walking cadence	up to 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4	Measure, from postoperative Day 1 up to Day 4 of time spent sitting/lying-down using ACTIM application	up to 4 days
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4	Measure, from postoperative Day 1 up to Day 4 of number of sitting-standing transition using ACTIM application.	up to 4 days
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4	Measure, from postoperative Day 1 up to Day 4 of step count using ACTIM application.	up to 4 days
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4	Measure, from postoperative Day 1 up to Day 4 of walking pace using ACTIM application.	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4	Measure of indicators of physical activity volume : Number of counts/day (Sum of counts (vertical axis) accumulated over the day) Number of steps/day (Sum of steps accumulated over the day)	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of physical activity intensity	Measure of indicators of physical activity intensity : Average number of counts/minute, Average walking pace (Average number of steps/minute).	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration	Measure of Indicators of duration : Sedentary time (Total minutes/day < 100 counts/minute), Light-intensity physical activity (Total minutes/day between 100 and 1,951 counts/minute), Moderate-intensity physical activity (Total minutes/day between 1,952 and 5,724 counts/minute), High-intensity physical activity (Total minutes/day ≥ 5,725 counts/minute), Moderate/high-intensity physical activity (Total minutes/day ≥ 1,952 counts/minute).	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration of walking at each intensity	Measure of indicators of duration of walking at each intensity : Occasional movement (Number of minutes with 1 to 19 steps/minute), Sporadic movement (Number of minutes with 20 to 39 steps/minute), Intentional walking (Number of minutes with 40 to 59 steps/minute), Slow walking (Number of minutes with 60 to 79 steps/minute), Moderate walking (Number of minutes with 80 to 99 steps/minute), Brisk walking (Number of minutes with 100 to 119 steps/minute), Fast walking (Number of minutes with ≥ 120 steps/minute),	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of energy expenditure	Measure of indicators of energy expenditure : physical activity-related energy expenditure estimated by a prediction equation	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of moderate to high-intensity physical activity	Measure of indicators of moderate to high-intensity physical activity : Number of sessions/day (Number of sessions (≥ 1 min) ≥ 1,952 counts/minute), Average session duration (Average session duration ≥ 1,952 counts/minute), Number of sessions ≥ 10 min (Number of sessions (≥ 10 min) ≥ 1,952 counts/minute), Total duration in sessions ≥ 10 min (Total duration of physical activity in sessions ≥ 10 min).	up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of sedentary	Measure of indicators of sedentary : Number of sessions/day (Session number (≥ 1 min) < 100 counts/minute), Average session duration (Average duration of sessions < 100 counts/minute), Number of sessions ≥ 10 min (Session number (≥ 10 min) < 100 counts/minute), Total duration in sessions ≥ 10 min (Total duration of sedentary behavior in sessions ≥ 10 min),	up to 4 days
Assess of the practical feasibility and level of satisfaction of the medical team regarding the personalized assessment obtained through ACTIM application	The level of satisfaction/feasibility with the ACTIM application will be assessed using a satisfaction scale from 0 to 10 (0: Not satisfactory and 10: Very satisfactory) when the device will be remove.	up to 4 days
Record patients' interest in the format and information contained in the personalized report	Using an interest scale from 0 to 10 (0: Not interesting to 10: Very interesting). The format in which this information is made available will be evaluated using a satisfaction scale (0: Not satisfactory to 10: Very satisfactory) when the device will be remove.	up to 4 days
Record postoperative complications	Postoperative complications will be recorded using the 'Morbidity and Mortality after Thoracic Surgery' classification from hospital discharge up to 1 month post surgery	up to 4 days
Assess patient acceptability of wearing the ActiGraph GT3X	Patients' acceptability of wearing the ActiGraph GT3X will be assessed when the equipment is removed, using a simple numerical scale ranging from 0 : unbearable to wear to 10 : no discomfort.	up to 4 days

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Julien FESSLER, MD, Foch Hospital

Publications and helpful links

General Publications

• Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
• Seely AJ, Ivanovic J, Threader J, Al-Hussaini A, Al-Shehab D, Ramsay T, Gilbert S, Maziak DE, Shamji FM, Sundaresan RS. Systematic classification of morbidity and mortality after thoracic surgery. Ann Thorac Surg. 2010 Sep;90(3):936-42; discussion 942. doi: 10.1016/j.athoracsur.2010.05.014.
• Daskivich TJ, Houman J, Lopez M, Luu M, Fleshner P, Zaghiyan K, Cunneen S, Burch M, Walsh C, Paiement G, Kremen T, Soukiasian H, Spitzer A, Jackson T, Kim HL, Li A, Spiegel B. Association of Wearable Activity Monitors With Assessment of Daily Ambulation and Length of Stay Among Patients Undergoing Major Surgery. JAMA Netw Open. 2019 Feb 1;2(2):e187673. doi: 10.1001/jamanetworkopen.2018.7673.
• Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
• Chomistek AK, Yuan C, Matthews CE, Troiano RP, Bowles HR, Rood J, Barnett JB, Willett WC, Rimm EB, Bassett DR Jr. Physical Activity Assessment with the ActiGraph GT3X and Doubly Labeled Water. Med Sci Sports Exerc. 2017 Sep;49(9):1935-1944. doi: 10.1249/MSS.0000000000001299.
• Ljungqvist O. ERAS--enhanced recovery after surgery: moving evidence-based perioperative care to practice. JPEN J Parenter Enteral Nutr. 2014 Jul;38(5):559-66. doi: 10.1177/0148607114523451. Epub 2014 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Thoracic surgery; ActiGraph GT3X; ACTIM application
• Other Study ID Numbers: 2020_0140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No