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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Physical Activity, Intelligent Electric Bike for Health, Connected Vest

Intervention / Treatment
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* Device: Programme of intelligent electric bike for health


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Programme of intelligent electric bike for health (single arm)<br>All volunteers will realise the programme of intelligent electric bike for health with connected vests. | Device: Programme of intelligent electric bike for health<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Connected bike, Connected vest, Rehabilitation