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

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: Lung Cancer
• Intervention / Treatment: Other: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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 .	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	one day before surgery
maximum distance covered in the 6-minute walking t	one day before surgery
post-surgery complications	At 1 month and 3 months
number of individuals who participated in the physical activity program	one day before surgery
post surgery intubation duration	At 1 month
number of days at hospital	At 3 months
number of days with oxygen	At 1 month and 3 months
(forced expiratory volume	At 1 month and 3 months
capacity of carbon monoxide	At 1 month and 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

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: smartwatch, lung cancer operation, physical exercices
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic
• 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