Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity for Oncology Patients

Fondation Audavie14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cancer Oncology

Interventions

Intelligent electric bicycle (VELIS) sessionsOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rocheplane Medical Center

Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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