NCT04667065

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

November 25, 2020

Last Update Submit

May 22, 2023

Conditions

Keywords

smartwatch, lung cancer operation, physical exercices

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

OTHER
Other: Physical activity

Interventions

Physical activity with the remotely guidance of physical activity teachers

Physical activity with smartwatch before bronchial cancer surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patient with non-small cell bronchial cancer with indication of curative surgical resection.
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

Locations