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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340857
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Floralis
eBikeLabs
Rocheplane Medical Center
Information provided by (Responsible Party):
Fondation Audavie

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)

Condition or disease Intervention/treatment Phase
Cancer Oncology Other: Intelligent electric bicycle (VELIS) sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of patients reaching the goal of 150 min equivalent of moderate physical activity per week (600 MET-min/week) [ Time Frame: 4 Months ]
    Evaluated with the IPAQ questionnaire short version (International Physical Activity Questionnaire)


Secondary Outcome Measures :
  1. Quantitative analysis of kinetic physical activity evolution [ 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 ]
    Longitudinal continue quantitative data from IPAQ score

  2. Evaluate the VELIS sessions feasibility n°1 [ Time Frame: 4 Months ]
    Number of cancelled sessions

  3. Evaluate the VELIS sessions feasibility n°2 [ Time Frame: 4 Months ]
    Number of incomplete sessions

  4. Evaluate the VELIS sessions feasibility n°3 [ Time Frame: 4 Months ]
    Collection of the failure reasons by the instructor

  5. Evaluate the impact on the physical capacities n°1 [ Time Frame: 4 Months ]
    Progression of the patients physical activity (clinical exam weight)

  6. Evaluate the impact on the physical capacities n°2 [ Time Frame: 4 Months ]
    Progression of the patients physical activity (heart rate)

  7. Evaluate the impact on the physical capacities n°3 [ Time Frame: 4 Months ]
    Progression of the patients physical activity (analysis of physio-cardiological criteria)

  8. Evaluate the impact on the physical capacities n°4 [ Time Frame: 4 Months ]
    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (initial gain in effort retraining)

  9. Evaluate the impact on the physical capacities n°5 [ Time Frame: 4 Months ]
    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (age)

  10. Evaluate the impact on the physical capacities n°6 [ Time Frame: 4 Months ]
    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (gender)

  11. Evaluate the impact on the physical capacities n°7 [ Time Frame: 4 Months ]
    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (pathologies)

  12. Evaluate the impact on the physical capacities n°8 [ Time Frame: 4 Months ]
    Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (endurance test on ergocycle)

  13. Evaluate the impact on the physical capacities n°9 [ Time Frame: 4 Months ]
    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)).

  14. Evaluate the impact on the physical capacities n°10 [ Time Frame: 4 Months ]
    Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (heart rate)

  15. Evaluate the impact on the physical capacities n°11 [ Time Frame: 4 Months ]
    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)

  16. Evaluate the impact on the physical capacities n°12 [ Time Frame: 4 Months ]
    Measurement of the muscular power using a handgrip (physiological parameter). Higher value is a better outcome.

  17. Improve quality of life [ Time Frame: 4 Months ]
    Euroquol 5 dimensions scale (from 0 to 100 : higher value is a better outcome)

  18. Improve fatigue n°1 [ Time Frame: 4 Months ]
    Analogic visual scale about fatigue once a month

  19. Improve fatigue n°2 [ Time Frame: 4 Months ]
    Fatigue Piper score

  20. Improve chronic pain [ Time Frame: 4 Months ]
    Analogic visual scale about pain once a month

  21. Improve self-esteem [ Time Frame: 4 Months ]
    Evaluation with Rosenberg score

  22. Improve patient satisfaction [ Time Frame: 4 Months ]
    Satisfaction survey and wish to do again intelligent electric bicycle (VELIS) sessions or to continue electric bicycle sessions

  23. Remove stereotypes that can lead to inhibition in the physical activity practice [ Time Frame: 4 Months ]

    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).

  24. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°1 [ Time Frame: 6 weeks ]
    Analysis of the parameters profiles recorded by the VELIS : heart rate monitor

  25. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°2 [ Time Frame: 6 weeks ]
    Analysis of the parameters profiles recorded by the VELIS : speed

  26. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°3 [ Time Frame: 6 weeks ]
    Analysis of the parameters profiles recorded by the VELIS : electric power provided by the engine

  27. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°4 [ Time Frame: 6 weeks ]
    Analysis of the parameters profiles recorded by the VELIS : rate of pedaling for the reference itinerary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340857


Locations
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France
Rocheplane Medical Center
Saint-Martin-d'Hères, Rhône-Alpes, France, 38400
Sponsors and Collaborators
Fondation Audavie
Floralis
eBikeLabs
Rocheplane Medical Center
Investigators
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Principal Investigator: Jean-Luc Bosson, MD Laboratoire TIMC - Themas

Additional Information:
Publications:

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Responsible Party: Fondation Audavie
ClinicalTrials.gov Identifier: NCT03340857    
Other Study ID Numbers: ONCOVELIS version 2.0
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Audavie:
Post-cancer retraining
Physical activity
Intelligent electric bicycle
Additional relevant MeSH terms:
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Neoplasms