Clinical trial NCT03920462: Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers (PROTOVELIS)
Official title: Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Intelligent Electric Bike for Health
Connected Vest
Keywords: Physical Activity
Connected bike
Connected vest
Rehabilitation
Lead sponsor: Laboratoire TIMC-IMAG
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Floralis
First posted: 2019-04-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of intelligent electric bike for health programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - volunteer".
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - volunteer".
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - volunteer".
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of general characteristics validated for each excursion evaluated by the questionnaire named "excursion evaluation - volunteer".
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - supervising staff".
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff".
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of general characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff".
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - supervising staff".
timeFrame: 1 month
measure: Percentage of data stored by the intelligent electric bike for health.
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of data stored by the connected vest Etisense.
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Comparison between data stored by the connected vest Etisense and the intelligent electric bike for health.
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Percentage of data stored by the connected vest Optimove.
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Compare data stored by the connected vest Optimove during two excursions with adjustments different of the intelligent electric bike for health.
timeFrame: 1st week, 2nd week, 3rd week and 4th week.
measure: Comparison between theoretical speed limit and real speed observed.
timeFrame: 1 month
measure: Capacity of the intelligent electric bike for health to offer entrainment capacities for a high-level athlete.
timeFrame: 1 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: BOSSON Jean-Luc
Study officials:
affiliation: TIMC-IMAG
name: Jean-luc BOSSON
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.
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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.
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.