Physical Activity Measure Application

Not Applicable

Recruiting

• Conditions: Physical Inactivity; Post-Surgical Complication
• Interventions: Device: Physical activity measure

• Registration Number: NCT06492161
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study Start: 2024-02-26
• Study First Submitted: 2024-06-24
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT3X ActiGraph's activity monitor	Physical activity measure	Patients who have undergone thoracic surgery wearing an ActiGraph GT3X-BT device that measures and records physical movement associated with daily activity.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration	up to 4 days	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).
Record postoperative complications	up to 4 days	Postoperative complications will be recorded using the 'Morbidity and Mortality after Thoracic Surgery' classification from hospital discharge up to 1 month post surgery
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration of walking at each intensity	up to 4 days	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),
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of sedentary	up to 4 days	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),
Assess of the practical feasibility and level of satisfaction of the medical team regarding the personalized assessment obtained through ACTIM application	up to 4 days	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.
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4	up to 4 days	Measure, from postoperative Day 1 up to Day 4 of walking pace using ACTIM application.
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of physical activity intensity	up to 4 days	Measure of indicators of physical activity intensity : Average number of counts/minute, Average walking pace (Average number of steps/minute).
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of energy expenditure	up to 4 days	Measure of indicators of energy expenditure : physical activity-related energy expenditure estimated by a prediction equation
Assess patient acceptability of wearing the ActiGraph GT3X	up to 4 days	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.
Record patients' interest in the format and information contained in the personalized report	up to 4 days	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.
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4	up to 4 days	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)
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of moderate to high-intensity physical activity	up to 4 days	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).

Trial Locations

Locations (1)

Foch Hospital; 🇫🇷 Suresnes, France