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Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers (PROTOVELIS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920462
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
TIMC-IMAG
Floralis
Information provided by (Responsible Party):
Laboratoire TIMC-IMAG

Brief Summary:

The walk and bike practice are two physical activities the most cited for benefits of physical activity thanks to their progressive and soft characters adapted to patients suffering from chronic diseases (diabetes, obesity, cancer...) with muscular deficit cardio-respiratory.

However, cycling may, depending on the natural land, imply efforts and articular-muscular-tendon pressions more important particularly in hilly natural land.

Moreover, lots of physical and physiological barriers oppose to the bike practice in the population of patients with chronic diseases. The electric bike can be useful.

This electric bike will be powerful but safe, totally programmable to adapt to patients, slope, rehabilitation objectives but very easy to use.

From medicine, it is necessary to ensure a moderate and regular effort regarding patients.

To do this, it is necessary to individualize adjustments of electric bike to have a progressive rehabilitation program and a progressive load force.

It needs to dispose monitoring and evaluation tools in real situations outside (lots of physiological and technical sensors). The intelligent electric bike for health proposes to be in accordance to this specifications.


Condition or disease Intervention/treatment Phase
Physical Activity Intelligent Electric Bike for Health Connected Vest Device: Programme of intelligent electric bike for health Not Applicable

Detailed Description:

The investigators propose to validate the technical and organizational feasibility of workshops using the intelligent electric bike for health with different devices such as two connected vests (non-invasive) measuring on the one hand the cardiological and respiratory parameters (connected vest named : Etisens) and the other hand the kinetic energy of movement (connected vest named : Optimove).

The development of this ambulatory physiology platform and the engine brake create perspectives for an outdoor rehabilitation tool that for example could stimulate, on an altitude free-excursion, a mountain pass of Alpes doing the link of health, sport and well-being.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers.
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Programme of intelligent electric bike for health (single arm)
All volunteers will realise the programme of intelligent electric bike for health with connected vests.
Device: Programme of intelligent electric bike for health
It is a programme of 6 excursions with an intelligent electric bike for health and connected vests during 1 month (two excursions per week according the weather)




Primary Outcome Measures :
  1. Percentage of intelligent electric bike for health programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - volunteer". [ Time Frame: 1 month ]
    Score of questionnaire "evaluation of the programme of intelligent electric bike for health - volunteer". A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.


Secondary Outcome Measures :
  1. Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - volunteer". [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    Score of questionnaire "excursion evaluation - volunteer" for each excursion. A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.

  2. Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - volunteer". [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]

    Score of items 1, 2 and 3 of questionnaire "excursion evaluation - volunteer" for each excursion.

    For item 1 and 2 ; a negative value is defined by a value less than 4 and greater than 6, and a positive value by a value between 4 and 6.

    For item 3 ; a negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.


  3. Percentage of general characteristics validated for each excursion evaluated by the questionnaire named "excursion evaluation - volunteer". [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]

    Score of items 1, 2, 3, 4 and 5 of questionnaire "excursion evaluation - volunteer" for each excursion.

    A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.


  4. Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - supervising staff". [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    Score of questionnaire "excursion evaluation - supervising staff" for each excursion. A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.

  5. Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff". [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    Score of items 1,2 and 3 of questionnaire "excursion evaluation - supervising staff" for each excursion. A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.

  6. Percentage of general characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff". [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]

    Score of items 1, 2, 3, 4 and 5 of questionnaire "excursion evaluation - supervising staff" for each excursion.

    A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.


  7. Percentage of programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - supervising staff". [ Time Frame: 1 month ]
    Score of questionnaire "evaluation of the programme of intelligent electric bike for health - supervising staff". A negative value is defined by a value less than 5 and a positive value is defined by a value greater than 5.

  8. Percentage of data stored by the intelligent electric bike for health. [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    The validation of records is defined when 90% of data is saved.

  9. Percentage of data stored by the connected vest Etisense. [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    The validation of records is defined when 90% of data is saved, all sensors are functional and data are relevant.

  10. Comparison between data stored by the connected vest Etisense and the intelligent electric bike for health. [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    Respiratory rate of the connected vest Etisense and the intelligent electric bike for health are compared.

  11. Percentage of data stored by the connected vest Optimove. [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    The validation of records is defined when 90% of data is saved.

  12. Compare data stored by the connected vest Optimove during two excursions with adjustments different of the intelligent electric bike for health. [ Time Frame: 1st week, 2nd week, 3rd week and 4th week. ]
    Data of the connected vest Optimove and the intelligent electric bike for health are compared.

  13. Comparison between theoretical speed limit and real speed observed. [ Time Frame: 1 month ]
    Speed recorded by the intelligent electric bike for health (real speed observed) and theoretical speed (programmed speed) are compared.

  14. Capacity of the intelligent electric bike for health to offer entrainment capacities for a high-level athlete. [ Time Frame: 1 month ]
    Description of features of the intelligent electric bike for health for entrainment of high-level athlete.



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:   Yes
Criteria

Inclusion Criteria:

  • Capacity to ride a bike
  • Volunteer without a contraindication to moderate physical activity or cycling (acute coronary artery disease less than 2 years old, musculoskeletal problem of the spine or lower limbs incompatible with cycling).
  • weight < 125 kg
  • volunteer available for an intervention of 2-3 hours twice a week during 1 month.

Exclusion Criteria:

  • Person deprived of liberty or 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): NCT03920462


Contacts
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Contact: Claire EYCHENNE 33 4 76 76 64 13 claire.eychenne@univ-grenoble-apes.fr
Contact: Carole ROLLAND 33 4 76 76 50 40 carole.rolland@univ-grenoble-alpes.fr

Sponsors and Collaborators
Laboratoire TIMC-IMAG
TIMC-IMAG
Floralis
Investigators
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Principal Investigator: Jean-luc BOSSON TIMC-IMAG
Additional Information:
Publications:
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Responsible Party: Laboratoire TIMC-IMAG
ClinicalTrials.gov Identifier: NCT03920462    
Other Study ID Numbers: 2019-A00997-50
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Laboratoire TIMC-IMAG:
Physical Activity
Connected bike
Connected vest
Rehabilitation