Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
PREPACHIR
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMay 23, 2023
May 1, 2023
4 months
November 25, 2020
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of VO2 max .
comparison of VO2 max at inclusion and one day before surgery
1 day before surgery
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
Physical activity with smartwatch before bronchial cancer surgery
OTHERInterventions
Physical activity with the remotely guidance of physical activity teachers
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier intercommunal de Créteil
Créteil, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2020
First Posted
December 14, 2020
Study Start
March 1, 2021
Primary Completion
July 1, 2021
Study Completion
January 1, 2023
Last Updated
May 23, 2023
Record last verified: 2023-05