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

May 22, 2023 updated by: Centre Hospitalier Intercommunal Creteil
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Centre Hospitalier Intercommunal de Créteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physical activity with smartwatch before bronchial cancer surgery
Other: Physical activity
Physical activity with the remotely guidance of physical activity teachers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of VO2 max .
Time Frame: 1 day before surgery
comparison of VO2 max at inclusion and one day before surgery
1 day before surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who used the remotely guided physical preparation
Time Frame: one day before surgery
one day before surgery
maximum distance covered in the 6-minute walking t
Time Frame: one day before surgery
one day before surgery
post-surgery complications
Time Frame: At 1 month and 3 months
At 1 month and 3 months
number of individuals who participated in the physical activity program
Time Frame: one day before surgery
one day before surgery
post surgery intubation duration
Time Frame: At 1 month
At 1 month
number of days at hospital
Time Frame: At 3 months
At 3 months
number of days with oxygen
Time Frame: At 1 month and 3 months
At 1 month and 3 months
(forced expiratory volume
Time Frame: At 1 month and 3 months
At 1 month and 3 months
capacity of carbon monoxide
Time Frame: At 1 month and 3 months
At 1 month and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREPACHIR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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