NCT03920462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

April 12, 2019

Last Update Submit

December 14, 2021

Conditions

Physical ActivityIntelligent Electric Bike for HealthConnected Vest

Keywords

Physical ActivityConnected bikeConnected vestRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - volunteer".

    1st week, 2nd week, 3rd week and 4th week.

  • Percentage of specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - volunteer".

    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".

    1st week, 2nd week, 3rd week and 4th week.

  • Percentage of excursions validated evaluated by the questionnaire "excursion evaluation - supervising staff".

    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".

    1st week, 2nd week, 3rd week and 4th week.

  • +9 more secondary outcomes

Study Arms (1)

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.

Device: Programme of intelligent electric bike for health

Interventions

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)

Programme of intelligent electric bike for health (single arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Person deprived of liberty or legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BOSSON Jean-Luc

Grenoble, 38000, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22182828BACKGROUND

  • 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.

    PMID: 17671237BACKGROUND

  • 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.

    PMID: 27299435BACKGROUND

  • 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.

    PMID: 22005715BACKGROUND

  • 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.

    PMID: 22913003BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jean-luc BOSSON

    TIMC-IMAG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire EYCHENNE

CONTACT

33 4 76 76 64 13claire.eychenne@univ-grenoble-apes.fr

Carole ROLLAND

CONTACT

33 4 76 76 50 40carole.rolland@univ-grenoble-alpes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 19, 2019

Study Start

December 13, 2021

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

January 5, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)