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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920462
• Other study ID #: 2019-A00997-50
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: June 2022

Study information

• Verified date: December 2021
• Source: Laboratoire TIMC-IMAG
• Contact: Claire EYCHENNE
• Phone: 33 4 76 76 64 13
• Email: claire.eychenne[@]univ-grenoble-apes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: June 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Connected Vest
• Intelligent Electric Bike for Health
• Physical Activity

Intervention

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)

Locations

Country	Name	City	State
France	BOSSON Jean-Luc	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
Laboratoire TIMC-IMAG	Floralis, TIMC-IMAG

Country where clinical trial is conducted

France, 

References & Publications (5)

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of intelligent electric bike for health programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - volunteer".	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.	1 month
Secondary	Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - volunteer".	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.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - volunteer".	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.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of general characteristics validated for each excursion evaluated by the questionnaire named "excursion evaluation - volunteer".	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.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - supervising staff".	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.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff".	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.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of general characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff".	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.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - supervising staff".	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.	1 month
Secondary	Percentage of data stored by the intelligent electric bike for health.	The validation of records is defined when 90% of data is saved.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of data stored by the connected vest Etisense.	The validation of records is defined when 90% of data is saved, all sensors are functional and data are relevant.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Comparison between data stored by the connected vest Etisense and the intelligent electric bike for health.	Respiratory rate of the connected vest Etisense and the intelligent electric bike for health are compared.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Percentage of data stored by the connected vest Optimove.	The validation of records is defined when 90% of data is saved.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Compare data stored by the connected vest Optimove during two excursions with adjustments different of the intelligent electric bike for health.	Data of the connected vest Optimove and the intelligent electric bike for health are compared.	1st week, 2nd week, 3rd week and 4th week.
Secondary	Comparison between theoretical speed limit and real speed observed.	Speed recorded by the intelligent electric bike for health (real speed observed) and theoretical speed (programmed speed) are compared.	1 month
Secondary	Capacity of the intelligent electric bike for health to offer entrainment capacities for a high-level athlete.	Description of features of the intelligent electric bike for health for entrainment of high-level athlete.	1 month

External Links

•   Des Asters R. The impact evaluation on the health, promotion of electric bike. 2006
•   Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike. 2016