Clinical trial NCT03340857: Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity for Oncology Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Oncology
Keywords: Post-cancer retraining
Physical activity
Intelligent electric bicycle
Lead sponsor: Fondation Audavie
Sponsor class: OTHER
Collaborators: name: Floralis
name: eBikeLabs
name: Rocheplane Medical Center
First posted: 2017-11-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 and over
* Patient who has followed a post-cancer effort retraining program in a rehabilitation facility at Rocheplane Medical Center
* Patient with the ability to pedal on an outdoor bicycle
* Patient with no restriction to moderate physical activity or bicycling (acute coronary disease of less than 2 years, locomotor problem of the spine or lower limbs incompatible with the practice of cycling)
* Weight less than 125 kg (maximum load for VELIS)
* Patient available for a 4 months follow-up

Exclusion Criteria:

* Patient with a restriction to the practice of moderate physical activity or bicycle (acute coronary disease of less than 2 years, locomotor problem)
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons), pregnant, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a legal protection measure

Primary outcomes:
measure: Percentage of patients reaching the goal of 150 min equivalent of moderate physical activity per week (600 MET-min/week)
timeFrame: 4 Months
Secondary outcomes:
measure: Quantitative analysis of kinetic physical activity evolution
timeFrame: Enrollment and then once a month from Month 2 to Month 4, the last week of the month, velis sessions and effort retraining excluded
measure: Evaluate the VELIS sessions feasibility n°1
timeFrame: 4 Months
measure: Evaluate the VELIS sessions feasibility n°2
timeFrame: 4 Months
measure: Evaluate the VELIS sessions feasibility n°3
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°1
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°2
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°3
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°4
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°5
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°6
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°7
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°8
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°9
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°10
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°11
timeFrame: 4 Months
measure: Evaluate the impact on the physical capacities n°12
timeFrame: 4 Months
measure: Improve quality of life
timeFrame: 4 Months
measure: Improve fatigue n°1
timeFrame: 4 Months
measure: Improve fatigue n°2
timeFrame: 4 Months
measure: Improve chronic pain
timeFrame: 4 Months
measure: Improve self-esteem
timeFrame: 4 Months
measure: Improve patient satisfaction
timeFrame: 4 Months
measure: Remove stereotypes that can lead to inhibition in the physical activity practice
timeFrame: 4 Months
measure: Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°1
timeFrame: 6 weeks
measure: Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°2
timeFrame: 6 weeks
measure: Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°3
timeFrame: 6 weeks
measure: Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°4
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint-Martin-d'Hères
country: France
facility: Rocheplane Medical Center
state: Rhône-Alpes
Study officials:
affiliation: Laboratoire TIMC - Themas
name: Jean-Luc Bosson, MD
role: PRINCIPAL_INVESTIGATOR
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