search
Back to results

Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery (PREPACHIR)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring smartwatch, lung cancer operation, physical exercices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major patient, age ≥ 18
  • Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy
  • Affiliated with a social security plan
  • VEMS < 80% and/or DLCO<80%
  • High-intensity training achievable for at least 10 days before surgery
  • Acceptant to participate in the protocol
  • Ability to follow the STIMUL program of education focused on adapted physical activity
  • Have a smartphone that can download the mobile app
  • have the ability to understand, read and write French

Exclusion Criteria:

  • Patient unable to consent: under guardianship or curatorship
  • Patient refusing surgery
  • Non-operable patient due to comorbidities or unseable tumour
  • Poor understanding of the smartwatch
  • Severe cognitive or psychiatric disorders
  • Pregnancy in progress

Sites / Locations

  • Centre hospitalier intercommunal de Créteil

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Physical activity with smartwatch before bronchial cancer surgery

Arm Description

Outcomes

Primary Outcome Measures

Measure of VO2 max .
comparison of VO2 max at inclusion and one day before surgery

Secondary Outcome Measures

Number of patients who used the remotely guided physical preparation
maximum distance covered in the 6-minute walking t
post-surgery complications
number of individuals who participated in the physical activity program
post surgery intubation duration
number of days at hospital
number of days with oxygen
(forced expiratory volume
capacity of carbon monoxide

Full Information

First Posted
November 25, 2020
Last Updated
May 22, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
search

1. Study Identification

Unique Protocol Identification Number
NCT04667065
Brief Title
Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
Acronym
PREPACHIR
Official Title
Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
smartwatch, lung cancer operation, physical exercices

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patient with non-small cell bronchial cancer with indication of curative surgical resection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity with smartwatch before bronchial cancer surgery
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
Physical activity with the remotely guidance of physical activity teachers
Primary Outcome Measure Information:
Title
Measure of VO2 max .
Description
comparison of VO2 max at inclusion and one day before surgery
Time Frame
1 day before surgery
Secondary Outcome Measure Information:
Title
Number of patients who used the remotely guided physical preparation
Time Frame
one day before surgery
Title
maximum distance covered in the 6-minute walking t
Time Frame
one day before surgery
Title
post-surgery complications
Time Frame
At 1 month and 3 months
Title
number of individuals who participated in the physical activity program
Time Frame
one day before surgery
Title
post surgery intubation duration
Time Frame
At 1 month
Title
number of days at hospital
Time Frame
At 3 months
Title
number of days with oxygen
Time Frame
At 1 month and 3 months
Title
(forced expiratory volume
Time Frame
At 1 month and 3 months
Title
capacity of carbon monoxide
Time Frame
At 1 month and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major patient, age ≥ 18 Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy Affiliated with a social security plan VEMS < 80% and/or DLCO<80% High-intensity training achievable for at least 10 days before surgery Acceptant to participate in the protocol Ability to follow the STIMUL program of education focused on adapted physical activity Have a smartphone that can download the mobile app have the ability to understand, read and write French Exclusion Criteria: Patient unable to consent: under guardianship or curatorship Patient refusing surgery Non-operable patient due to comorbidities or unseable tumour Poor understanding of the smartwatch Severe cognitive or psychiatric disorders Pregnancy in progress
Facility Information:
Facility Name
Centre hospitalier intercommunal de Créteil
City
Créteil
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery

We'll reach out to this number within 24 hrs