Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT03340857
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2017-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity for Oncology Patients
Sponsor:
Fondation Audavie
Organization:
Study Overview
Official Title:
Evaluation of the Use of an Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity After a Stay for Effort Retraining in Rehabilitation and Recuperative Care Facilities for Oncology Patients
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this pilot study is to encourage oncology patients to continue effort retraining after their release from rehabilitation and recuperative care facilities with physical activity sessions and therapeutic education using an intelligent electric bicycle (VELIS)
Detailed Description:
The benefit of physical activity in oncology is now clearly established. Physical activity has its place at all stages of the fight against cancer in primary, secondary and tertiary prevention.
Rehabilitation and recuperative care facilities may be a first step for patients with significant deconditioning, but long-term benefits are essential.
Nevertheless, the post rehabilitation and recuperative care facilities transition period is for these patients a temporary period during which they may loose part of the benefit of effort retraining and physical reconditioning.
The investigators believe that it is necessary to go beyond the "physiological" efficiency to identify and overcome the patient's stereotypes regarding physical activity, to customize and adapt the programs to each patient, and to bring quickly the notion of pleasure and success in the practice of physical activity. Electrically assisted bicycles can reach most of these goals provided that they are adapted.
The objective of this project is to set up and evaluate, thanks to a monocentric pilot study, a process of continuation of exercise retraining through physical activity and therapeutic education sessions for the promotion of physical activity, focusing on the use of electrically assisted bicycles, in continuation of an exercise retraining in rehabilitation and recuperative care facilities.
Rehabilitation and recuperative care facilities may be a first step for patients with significant deconditioning, but long-term benefits are essential.
Nevertheless, the post rehabilitation and recuperative care facilities transition period is for these patients a temporary period during which they may loose part of the benefit of effort retraining and physical reconditioning.
The investigators believe that it is necessary to go beyond the "physiological" efficiency to identify and overcome the patient's stereotypes regarding physical activity, to customize and adapt the programs to each patient, and to bring quickly the notion of pleasure and success in the practice of physical activity. Electrically assisted bicycles can reach most of these goals provided that they are adapted.
The objective of this project is to set up and evaluate, thanks to a monocentric pilot study, a process of continuation of exercise retraining through physical activity and therapeutic education sessions for the promotion of physical activity, focusing on the use of electrically assisted bicycles, in continuation of an exercise retraining in rehabilitation and recuperative care facilities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: