Physical ActivityNCT03920462
Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers (PROTOVELIS)
A study testing Programme of intelligent electric bike for health in people with Physical Activity and Intelligent Electric Bike for Health, run by Laboratoire TIMC-IMAG at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Intelligent Electric Bike for Health, Connected Vest
- What is being tested?
- Programme of intelligent electric bike for health
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Person deprived of liberty or legal protection measure
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
BOSSON Jean-Luc
Grenoble, 38000
Jean-Luc BOSSON, 04 76 76 50 40, jean-luc.bosson@univ-grenoble-alpes.fr
About this study
Official title: Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers.
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.
Read more
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.
Read the 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.
- Being tested
- Programme of intelligent electric bike for health
- Keywords
- Physical Activity, Connected bike, Connected vest, Rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programme of intelligent electric bike for healthDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Programme of intelligent electric bike for health (single arm) | Other | All volunteers will realise the programme of intelligent electric bike for health with connected vests. Receives: Device: Programme of intelligent electric bike for health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start13 Dec 2021
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire TIMC-IMAG
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, Floralis
- Responsible party
- Sponsor
- Investigators
- Jean-luc BOSSON, Principal investigator, TIMC-IMAG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920462
- Sponsor's protocol ID
- 2019-A00997-50
- Status last verified
- Dec 2021
- First submitted
- 12 Apr 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22182828Haskell 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.
PubMed 17671237Peterman 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.
PubMed 27299435Gojanovic 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.
PubMed 22005715Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.
PubMed 22913003
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03920462
- Acronym / sponsor ID
- 2019-A00997-50
- Keywords
- Physical Activity, Connected bike, Connected vest, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Laboratoire TIMC-IMAGUniversity, hospital or other
- Collaborators
- TIMC-IMAG, Floralis
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.
| Arm | Type | Receives |
|---|---|---|
| Programme of intelligent electric bike for health (single arm) | Other | Device: Programme of intelligent electric bike for healthAll volunteers will realise the programme of intelligent electric bike for health with connected vests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Person deprived of liberty or legal protection measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programme of intelligent electric bike for healthIt 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) | Device | Programme of intelligent electric bike for health (single arm) |
Primary outcome
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.
14 secondary outcomes
Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - volunteer".
Time frame: 1st week, 2nd week, 3rd week and 4th week.
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.
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.
Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - supervising staff".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 1 month
Percentage of data stored by the intelligent electric bike for health.
Time frame: 1st week, 2nd week, 3rd week and 4th week.
Percentage of data stored by the connected vest Etisense.
Time frame: 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.
Time frame: 1st week, 2nd week, 3rd week and 4th week.
Percentage of data stored by the connected vest Optimove.
Time frame: 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.
Time frame: 1st week, 2nd week, 3rd week and 4th week.
Comparison between theoretical speed limit and real speed observed.
Time frame: 1 month
Capacity of the intelligent electric bike for health to offer entrainment capacities for a high-level athlete.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 22182828Pavey 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.
- Background: PubMed 17671237Haskell 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.
- Background: PubMed 27299435Peterman 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.
- Background: PubMed 22005715Gojanovic 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.
- Background: PubMed 22913003Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.
- Des Asters R. The impact evaluation on the health, promotion of electric bike. 2006Link provided by the sponsor.
- Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike. 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-luc BOSSON principal investigator
TIMC-IMAG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programme of intelligent electric bike for health in people with Physical Activity and Intelligent Electric Bike for Health, run by Laboratoire TIMC-IMAG at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire EYCHENNE (33 4 76 76 64 13, claire.eychenne@univ-grenoble-apes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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". (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920462, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.