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

Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667065
• Other study ID #: PREPACHIR
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 1, 2023
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Bronchogenic
• Lung Cancer

Intervention

Other:
• Physical activity
Physical activity with the remotely guidance of physical activity teachers

Locations

Country	Name	City	State
France	Centre hospitalier intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of VO2 max .	comparison of VO2 max at inclusion and one day before surgery	1 day before surgery
Secondary	Number of patients who used the remotely guided physical preparation		one day before surgery
Secondary	maximum distance covered in the 6-minute walking t		one day before surgery
Secondary	post-surgery complications		At 1 month and 3 months
Secondary	number of individuals who participated in the physical activity program		one day before surgery
Secondary	post surgery intubation duration		At 1 month
Secondary	number of days at hospital		At 3 months
Secondary	number of days with oxygen		At 1 month and 3 months
Secondary	(forced expiratory volume		At 1 month and 3 months
Secondary	capacity of carbon monoxide		At 1 month and 3 months