Measurement of Physical Activity in the First Days After... | NCT04583176

Studies
Measurement of Physical Activity in the First Days After Thoracic Surgery

NCT04583176

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Jan 19, 2022Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Pulmonary Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2020Actual

Primary Completion Date

Jul 13, 2021Actual

Completion Date

Jul 13, 2021Actual

First Submitted Date

Oct 5, 2020

First Submission Date that Met QC Criteria

Oct 5, 2020

First Posted Date

Oct 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2022

Last Update Posted Date

Jan 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective measurement of physical activity has several advantages compared to declarative measures: exemption from memory bias and desirability bias, more precise evaluation, taken into account activities of low intensity, measurement of physical activity and sedentariness profiles (number and duration of periods of activity, number of breaks in sedentary lifestyles).

The aim of this study is to assess the early postoperative mobility of patients who have undergone pulmonary excision by thoracoscopy or robot surgery using ActiGraph GT3X accelerometer. This assessment will serve as a reference element for further studies.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of postoperative mobility during the first postoperative days	Number of steps	Day 5

Secondary Outcomes

Measure	Description	Time Frame
Volume of physical activity assessed by accelerometry during the first postoperative days	Total activity counts per day	Day 5
Overall intensity of physical activity assessed by accelerometry during the first postoperative days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Having to undergo pulmonary excision by thoracoscopy or robotic surgery
Accepting to wear a belt fitted with an ActiGraph GT3X accelerometer for a maximum of 5 days post surgery
Affiliated to a Health Insurance plan
Having given an oral non-opposition

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients having to undergo pulmonary excision by thoracoscopy or robotic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julien FESSLER, MD	Foch Hospital	Principal Investigator
Marc FISCHLER, PhD	Foch Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Foch		Suresnes		92150	France

Type	Date	Date Unknown
Release	Jun 9, 2026
Reset	Jul 2, 2026

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 9, 2026			Jul 2, 2026

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D009043	Motor Activity

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided