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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340857
• Other study ID #: ONCOVELIS version 2.0
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2020
• Source: Fondation Audavie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Oncology

Intervention

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

Locations

Country	Name	City	State
France	Rocheplane Medical Center	Saint-Martin-d'Hères	Rhône-Alpes

Sponsors (4)

Lead Sponsor	Collaborator
Fondation Audavie	eBikeLabs, Floralis, Rocheplane Medical Center

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. Epub 2007 Aug 1. — View Citation

Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Ávila JM, Aranceta-Batrina J, Gil Á, Ortega RM, Serra-Majem L, Varela-Moreiras G, González-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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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

External Links

•   3rd report INCA february 2017
•   Evaluation of the impact on health. Promotion of the electrical bike. Final report. 2006
•   Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike JULY 6, 2016 6:00 AM July 6, 2016.