An interventional study of Intelligent electric bicycle (VELIS) sessions in Cancer and Oncology, sponsored by Fondation Audavie. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Fondation Audavie · Not applicable, Interventional, and Other
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)
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Fondation Audavie as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intelligent electric bicycle (VELIS) sessions with an instructor, twice a week for 6 weeks
Other: Intelligent electric bicycle (VELIS) sessions
Oncology patients will participate in intelligent electric bicycle (VELIS) sessions twice a week for 6 weeks after their release from a rehabilitation and recuperative care facility
Percentage of patients reaching the goal of 150 min equivalent of moderate physical activity per week (600 MET-min/week)
Evaluated with the IPAQ questionnaire short version (International Physical Activity Questionnaire)
Time frame: 4 Months
Quantitative analysis of kinetic physical activity evolution
Longitudinal continue quantitative data from IPAQ score
Time frame: Enrollment and then once a month from Month 2 to Month 4, the last week of the month, velis sessions and effort retraining excluded
Evaluate the VELIS sessions feasibility n°1
Number of cancelled sessions
Time frame: 4 Months
Evaluate the VELIS sessions feasibility n°2
Number of incomplete sessions
Time frame: 4 Months
Evaluate the VELIS sessions feasibility n°3
Collection of the failure reasons by the instructor
Time frame: 4 Months
Evaluate the impact on the physical capacities n°1
Progression of the patients physical activity (clinical exam weight)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°2
Progression of the patients physical activity (heart rate)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°3
Progression of the patients physical activity (analysis of physio-cardiological criteria)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°4
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (initial gain in effort retraining)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°5
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (age)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°6
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (gender)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°7
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (pathologies)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°8
Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (endurance test on ergocycle)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°9
Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (evaluation with the quantitative Borg scale (from Pr Gunnar BORG) from 0 to 10 (the goal score is 4 to 5)).
Time frame: 4 Months
Evaluate the impact on the physical capacities n°10
Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (heart rate)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°11
Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (visual analogical scale from 0 (no pain) to 10 (maximal pain) for the lower limbs pain. Lower value is a better outcome)
Time frame: 4 Months
Evaluate the impact on the physical capacities n°12
Measurement of the muscular power using a handgrip (physiological parameter). Higher value is a better outcome.
Time frame: 4 Months
Improve quality of life
Euroquol 5 dimensions scale (from 0 to 100 : higher value is a better outcome)
Time frame: 4 Months
Improve fatigue n°1
Analogic visual scale about fatigue once a month
Time frame: 4 Months
Improve fatigue n°2
Fatigue Piper score
Time frame: 4 Months
Improve chronic pain
Analogic visual scale about pain once a month
Time frame: 4 Months
Improve self-esteem
Evaluation with Rosenberg score
Time frame: 4 Months
Improve patient satisfaction
Satisfaction survey and wish to do again intelligent electric bicycle (VELIS) sessions or to continue electric bicycle sessions
Time frame: 4 Months
Remove stereotypes that can lead to inhibition in the physical activity practice
Evaluation of the psychological representation of physical activity using the Cancer Exercise Stereotypes Scale (CESS) questionnaire from the SENS (sport and social environment laboratory) team from Grenoble. The average value is calculated for each subscale. Adherence to positive stereotypes if value is below 4 for the following subscale : * Lack of interest in physical activity (items 1, 6, 11) * Side effects related to treatment (items 3, 8, 13, 17) * Risks related to physical activity (items 5, 10, 15) Adherence to positive stereotypes if value is greater than 4 for the subscale Benefits of physical activity (items 4, 9, 14, 18).
Time frame: 4 Months
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°1
Analysis of the parameters profiles recorded by the VELIS : heart rate monitor
Time frame: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°2
Analysis of the parameters profiles recorded by the VELIS : speed
Time frame: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°3
Analysis of the parameters profiles recorded by the VELIS : electric power provided by the engine
Time frame: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°4
Analysis of the parameters profiles recorded by the VELIS : rate of pedaling for the reference itinerary
Time frame: 6 weeks
Ran from Oct 2017 to primary completion in Oct 2018, 12 months.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 12 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.