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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Bicycle-sharing Program on Health

NCT04629261

Physical Activity

UNKNOWN NA

Physical Activity and Sedentary Behaviour Associated With Utilitarian E-bike Use

NCT03307473

All-comers

COMPLETED

Evaluation of a Spatio-behavioral Application

NCT04167124

Physical Activity

COMPLETED NA

Cardiorespiratory Fitness Using Electrically Assisted Bicycles

NCT03143764

Diabetes Mellitus, Type 2

COMPLETED NA

Health and Exercise Response in Children With Chronic and Auto-immune Pathologies

NCT03913962

Juvenile Idiopathic Arthritis Diabetes Inflammatory Bowel Disease +2 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Activity Intelligent Electric Bike for Health Connected Vest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

All volunteers realise a programme of 6 excursions with intelligent electric bike for health and connected vests.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Programme of intelligent electric bike for health (single arm)

All volunteers will realise the programme of intelligent electric bike for health with connected vests.

Group Type OTHER

Programme of intelligent electric bike for health

Intervention Type DEVICE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.