Physical Activity Measure Application

NCT06492161 | Completed

• 1 other identifier: 2020_0140
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Inactivity; Post-Surgical Complication

Keywords

ActiGraph GT3X; Physical activity; Thoracic surgery; ACTIM application

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4

  up to 4 days

• Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4

  up to 4 days

• Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4

  up to 4 days

• Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4

  up to 4 days

• Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4

  up to 4 days

Study Arms (1)

GT3X ActiGraph's activity monitor

EXPERIMENTAL

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

Interventions

Physical activity measure DEVICE

After surgery, patients patients will be fitted with GT3X ActiGraph's activity monitor to capture and record continuous physical activity.

GT3X ActiGraph's activity monitor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Foch Hospital

Suresnes, 92150, France

Location

Related Publications (6)

• 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.

  PMID: 15896435 BACKGROUND

• 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.

  PMID: 24567343 BACKGROUND

• 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.

  PMID: 9175983 BACKGROUND

• 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.

  PMID: 28419028 BACKGROUND

• 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.

  PMID: 30707226 BACKGROUND

• 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.

  PMID: 20732521 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Julien FESSLER, MD

  Foch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 9, 2024
• Study Start: February 26, 2024
• Primary Completion: February 26, 2025
• Study Completion: February 28, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)