跳至主要内容
临床试验/NCT03920462
NCT03920462Unknown不适用

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

Laboratoire TIMC-IMAG1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
8
试验地点
1
主要终点
Percentage of intelligent electric bike for health programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - volunteer".

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •Person deprived of liberty or legal protection measure

研究组 & 干预措施

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.

干预措施: Programme of intelligent electric bike for health (Device)

结局指标

主要结局

Percentage of intelligent electric bike for health programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - volunteer".

时间窗: 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.

次要结局

  • Percentage of excursions validated 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 "excursion evaluation - supervising staff".(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.(1st week, 2nd week, 3rd week and 4th week.)
  • Capacity of the intelligent electric bike for health to offer entrainment capacities for a high-level athlete.(1 month)
  • 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 data stored by the connected vest Etisense.(1st week, 2nd week, 3rd week and 4th week.)
  • Percentage of data stored by the connected vest Optimove.(1st week, 2nd week, 3rd week and 4th week.)
  • Comparison between theoretical speed limit and real speed observed.(1 month)
  • 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 specific characteristics validated for each excursion evaluated by the questionnaire "excursion evaluation - supervising staff".(1st week, 2nd week, 3rd week and 4th week.)
  • Percentage of data stored by the intelligent electric bike for health.(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.(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 programme validated evaluated by the questionnaire "evaluation of the programme of intelligent electric bike for health - supervising staff".(1 month)

研究者

发起方
Laboratoire TIMC-IMAG
申办方类型
Other
责任方
Sponsor

研究点 (1)

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