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

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

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)

Study Overview

• Status: Completed
• Conditions: Cancer; Oncology
• Intervention / Treatment: Other: Intelligent electric bicycle (VELIS) sessions

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône-Alpes
    • Saint-Martin-d'Hères, Rhône-Alpes, France, 38400
      • Rocheplane Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intelligent electric bicycle (VELIS) sessions; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative analysis of kinetic physical activity evolution	Longitudinal continue quantitative data from IPAQ score	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	4 Months
Evaluate the VELIS sessions feasibility n°2	Number of incomplete sessions	4 Months
Evaluate the VELIS sessions feasibility n°3	Collection of the failure reasons by the instructor	4 Months
Evaluate the impact on the physical capacities n°1	Progression of the patients physical activity (clinical exam weight)	4 Months
Evaluate the impact on the physical capacities n°2	Progression of the patients physical activity (heart rate)	4 Months
Evaluate the impact on the physical capacities n°3	Progression of the patients physical activity (analysis of physio-cardiological criteria)	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)	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)	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)	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)	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)	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)).	4 Months
Evaluate the impact on the physical capacities n°10	Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (heart rate)	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)	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.	4 Months
Improve quality of life	Euroquol 5 dimensions scale (from 0 to 100 : higher value is a better outcome)	4 Months
Improve fatigue n°1	Analogic visual scale about fatigue once a month	4 Months
Improve fatigue n°2	Fatigue Piper score	4 Months
Improve chronic pain	Analogic visual scale about pain once a month	4 Months
Improve self-esteem	Evaluation with Rosenberg score	4 Months
Improve patient satisfaction	Satisfaction survey and wish to do again intelligent electric bicycle (VELIS) sessions or to continue electric bicycle sessions	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).	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	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	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	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	6 weeks

Collaborators and Investigators

• Sponsor: Fondation Audavie
• Collaborators: Floralis; eBikeLabs; Rocheplane Medical Center
• Investigators: Principal Investigator: Jean-Luc Bosson, MD, Laboratoire TIMC - Themas

Publications and helpful links

General Publications

• Pavey TG, Anokye N, Taylor AH, Trueman P, Moxham T, Fox KR, Hillsdon M, Green C, Campbell JL, Foster C, Mutrie N, Searle J, Taylor RS. The clinical effectiveness and cost-effectiveness of exercise referral schemes: a systematic review and economic evaluation. Health Technol Assess. 2011 Dec;15(44):i-xii, 1-254. doi: 10.3310/hta15440.
• Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.
• Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.
• Gojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.
• Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.
• Phillips SM, Alfano CM, Perna FM, Glasgow RE. Accelerating translation of physical activity and cancer survivorship research into practice: recommendations for a more integrated and collaborative approach. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):687-99. doi: 10.1158/1055-9965.EPI-13-1355. Epub 2014 Mar 5.
• Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
• Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Avila JM, Aranceta-Batrina J, Gil A, Ortega RM, Serra-Majem L, Varela-Moreiras G, Gonzalez-Gross M. Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study. PLoS One. 2016 Feb 25;11(2):e0149969. doi: 10.1371/journal.pone.0149969. eCollection 2016.
• Simons M, Van Es E, Hendriksen I. Electrically assisted cycling: a new mode for meeting physical activity guidelines? Med Sci Sports Exerc. 2009 Nov;41(11):2097-102. doi: 10.1249/MSS.0b013e3181a6aaa4.
• Falzon C, Sabiston C, Bergamaschi A, Corrion K, Chalabaev A, D'Arripe-Longueville F. Development and validation of the Cancer Exercise Stereotypes Scale. J Psychosoc Oncol. 2014;32(6):708-26. doi: 10.1080/07347332.2014.955237.
• Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.

Helpful Links

• 3rd report INCA february 2017
• Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike JULY 6, 2016 6:00 AM July 6, 2016.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2017
• Primary Completion (ACTUAL): October 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (ACTUAL): November 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Physical activity; Post-cancer retraining; Intelligent electric bicycle
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ONCOVELIS version 2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No