- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920462
Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers (PROTOVELIS)
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire EYCHENNE
- Phone Number: 33 4 76 76 64 13
- Email: claire.eychenne@univ-grenoble-apes.fr
Study Locations
-
-
-
Grenoble, France, 38000
- Recruiting
- BOSSON Jean-Luc
-
Contact:
- Jean-Luc BOSSON
- Phone Number: 04 76 76 50 40
- Email: jean-luc.bosson@univ-grenoble-alpes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Programme of intelligent electric bike for health (single arm)
All volunteers will realise the programme of intelligent electric bike for health with connected vests.
|
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)
|
What is the study measuring?
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".
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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".
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. |
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.
|
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".
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.
|
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.
|
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".
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.
|
1 month
|
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.
|
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.
|
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.
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.
|
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.
|
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.
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.
|
1st week, 2nd week, 3rd week and 4th week.
|
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.
|
1 month
|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-luc BOSSON, Timc-Imag
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-A00997-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on Programme of intelligent electric bike for health
-
University Hospital, GrenobleNot yet recruitingChronic Pain | Fibromyalgia | Adapted Physical Activity | Therapeutic Education | Electric Bike
-
Technische Universitaet BraunschweigUniversity of Oxford; University of Cape Town; Bangor University; Georgia State... and other collaboratorsCompletedChild Mental DisorderRomania, Macedonia, The Former Yugoslav Republic of, Moldova, Republic of
-
Beijing Friendship HospitalNot yet recruitingLiver Cirrhosis | Hepatitis B
-
King's College LondonCompletedDementiaUnited Kingdom
-
Florida State UniversityUniversity of North Carolina, Chapel Hill; University of GeorgiaEnrolling by invitationCardiovascular Disease Risk ReductionUnited States
-
End-of-Life Research GroupKU Leuven; Amsterdam UMC, location VUmc; Agentschap voor Innovatie door Wetenschap... and other collaboratorsCompletedOlder Patients Dying in Acute Geriatric Hospital WardsBelgium
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedCardiovascular DiseaseNetherlands
-
Clinica Universidad de Navarra, Universidad de...Completed
-
University of HullBritish Dietetic AssociationCompleted