Physical InactivityMARCHENCT06492161
Physical Activity Measure Application
A study testing Physical activity measure in people with Physical Inactivity and Post-Surgical Complication, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Physical Inactivity, Post-Surgical Complication
- What is being tested?
- Physical activity measure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding woman
- Patient unable to move independently (paraplegic, etc.)
- Patient deprived of liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Inactivity, Post-Surgical Complication
- Being tested
- Physical activity measure
- Keywords
- ActiGraph GT3X, Physical activity, Thoracic surgery, ACTIM application
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity measureDevice
After surgery, patients patients will be fitted with GT3X ActiGraph's activity monitor to capture and record continuous physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Physical activity measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 4 days
Secondary outcomes (15)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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),
Measured: 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
Measured: 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).
Measured: 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),
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start26 Feb 2024
- Primary completion26 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien FESSLER, MD, Principal investigator, Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492161
- Sponsor's protocol ID
- 2020_0140
- Acronym
- MARCHE
- Status last verified
- Apr 2025
- First submitted
- 24 Jun 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15896435Ljungqvist 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.
PubMed 24567343Kehlet 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.
PubMed 9175983Chomistek 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.
PubMed 28419028Daskivich 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.
PubMed 30707226Seely 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.
PubMed 20732521
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Application Allowing Physical Activity to Get Information on Their Physical Activity in the First Days Following Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06492161
- Acronym / sponsor ID
- MARCHE / 2020_0140
- Conditions
- Physical Inactivity, Post-Surgical Complication
- Keywords
- ActiGraph GT3X, Physical activity, Thoracic surgery, ACTIM application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT3X ActiGraph's activity monitor | Experimental | Device: Physical activity measurePatients who have undergone thoracic surgery wearing an ActiGraph GT3X-BT device that measures and records physical movement associated with daily activity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Patient unable to move independently (paraplegic, etc.)
- Patient deprived of liberty or under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity measureAfter surgery, patients patients will be fitted with GT3X ActiGraph's activity monitor to capture and record continuous physical activity. | Device | GT3X ActiGraph's activity monitor |
Primary outcome
Assess the agreement between ACTIM application and Actilife Softawre for the sitting-lying position
Time frame: up to 4 days
Measure, from postoperative Day 1 up to Day 4 of time spent sitting/lying-down
Assess the agreement between ACTIM application and Actilife Softawre for sitting-standing transition
Time frame: 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
Time frame: 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
Time frame: up to 4 days
Measure, from postoperative Day 1 up to Day 4 of number of walking cadence
15 secondary outcomes
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
Time frame: up to 4 days
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
Time frame: up to 4 days
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
Time frame: up to 4 days
Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4
Time frame: up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4
Time frame: up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of physical activity intensity
Time frame: up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration
Time frame: 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
Time frame: up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of energy expenditure
Time frame: 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
Time frame: up to 4 days
Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of sedentary
Time frame: 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
Time frame: up to 4 days
Record patients' interest in the format and information contained in the personalized report
Time frame: up to 4 days
Record postoperative complications
Time frame: up to 4 days
Assess patient acceptability of wearing the ActiGraph GT3X
Time frame: up to 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 15896435Fearon 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.
- Results publication: PubMed 24567343Ljungqvist 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.
- Results publication: PubMed 9175983Kehlet 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.
- Results publication: PubMed 28419028Chomistek 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.
- Results publication: PubMed 30707226Daskivich 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.
- Results publication: PubMed 20732521Seely 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien FESSLER, MD principal investigator
Foch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity measure in people with Physical Inactivity and Post-Surgical Complication, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the agreement between ACTIM application and Actilife Softawre for the sitting-lying position (time frame: up to 4 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492161, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.