Clinical trial NCT06492161: Physical Activity Measure Application
Official title: Evaluation of an Application Allowing Physical Activity to Get Information on Their Physical Activity in the First Days Following Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Post-Surgical Complication
Keywords: ActiGraph GT3X
Physical activity
Thoracic surgery
ACTIM application
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the agreement between ACTIM application and Actilife Softawre for the sitting-lying position
timeFrame: up to 4 days
measure: Assess the agreement between ACTIM application and Actilife Softawre for sitting-standing transition
timeFrame: up to 4 days
measure: Assess the agreement between ACTIM application and Actilife Softawre for step count
timeFrame: up to 4 days
measure: Assess the agreement between ACTIM application and Actilife Softawre for walking pace
timeFrame: up to 4 days
Secondary outcomes:
measure: Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
timeFrame: up to 4 days
measure: Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
timeFrame: up to 4 days
measure: Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
timeFrame: up to 4 days
measure: Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of physical activity intensity
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration of walking at each intensity
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of energy expenditure
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of moderate to high-intensity physical activity
timeFrame: up to 4 days
measure: Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of sedentary
timeFrame: up to 4 days
measure: Assess of the practical feasibility and level of satisfaction of the medical team regarding the personalized assessment obtained through ACTIM application
timeFrame: up to 4 days
measure: Record patients' interest in the format and information contained in the personalized report
timeFrame: up to 4 days
measure: Record postoperative complications
timeFrame: up to 4 days
measure: Assess patient acceptability of wearing the ActiGraph GT3X
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Foch Hospital
name: Julien FESSLER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.