Measurement of Physical Activity in the First Days After Thoracic Surgery

Pulmonary Disease Clinical Trial

— Marchez  

Official title:

Measurement of Physical Activity in the First Days After Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583176
• Other study ID #: 2020_0046
• Status: Completed
• Start date: November 16, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: January 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of postoperative mobility during the first postoperative days	Number of steps	Day 5
Secondary	Volume of physical activity assessed by accelerometry during the first postoperative days	Total activity counts per day	Day 5
Secondary	Overall intensity of physical activity assessed by accelerometry during the first postoperative days	Steps and counts per hour and per minute	Day 5
Secondary	Duration and intensity of physical activity assessed by accelerometry during the first postoperative days	Time in physical activity of different intensities	Day 5
Secondary	Sedentary time assessed by accelerometry during the first postoperative days	Total sedentary time	Day 5
Secondary	Best natural effort assessed by accelerometry during the first postoperative days	Peak cadence	Day 5
Secondary	Patterns of physical activity assessed by accelerometry during the first postoperative days	Number and mean duration of bouts of physical activity	Day 5
Secondary	Patterns of sedentary behavior assessed by accelerometry during the first postoperative days	Number and mean duration of bouts of sedentary behavior	Day 5
Secondary	Physiotherapists' evaluation during the first post-operative days	Daily activity assessment after thoracic surgery Questionnaire	Day 5
Secondary	Postoperative analgesia	Daily activity assessment after thoracic surgery Questionnaire	Day 5
Secondary	Assessement of patient acceptability for wearing the ActiGraph GT3X	Digital assessment scale	Day 5
Secondary	Postoperative complications	Morbidity and Mortality after Thoracic Surgery Classification	Day 5