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Completed

NCT Number: NCT03340857

Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity for Oncology Patients

The purpose of this pilot study is to encourage oncology patients to continue effort retraining after their release from rehabilitation and recuperative care facilities with physical activity sessions and therapeutic education using an intelligent electric bicycle (VELIS)

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocheplane Medical Center

Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, 38400, France

About this study

The benefit of physical activity in oncology is now clearly established. Physical activity has its place at all stages of the fight against cancer in primary, secondary and tertiary prevention.

Rehabilitation and recuperative care facilities may be a first step for patients with significant deconditioning, but long-term benefits are essential.

Nevertheless, the post rehabilitation and recuperative care facilities transition period is for these patients a temporary period during which they may loose part of the benefit of effort retraining and physical reconditioning.

The investigators believe that it is necessary to go beyond the "physiological" efficiency to identify and overcome the patient's stereotypes regarding physical activity, to customize and adapt the programs to each patient, and to bring quickly the notion of pleasure and success in the practice of physical activity. Electrically assisted bicycles can reach most of these goals provided that they are adapted.

The objective of this project is to set up and evaluate, thanks to a monocentric pilot study, a process of continuation of exercise retraining through physical activity and therapeutic education sessions for the promotion of physical activity, focusing on the use of electrically assisted bicycles, in continuation of an exercise retraining in rehabilitation and recuperative care facilities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 18 and over
  • Patient who has followed a post-cancer effort retraining program in a rehabilitation facility at Rocheplane Medical Center
  • Patient with the ability to pedal on an outdoor bicycle
  • Patient with no restriction to moderate physical activity or bicycling (acute coronary disease of less than 2 years, locomotor problem of the spine or lower limbs incompatible with the practice of cycling)
  • Weight less than 125 kg (maximum load for VELIS)
  • Patient available for a 4 months follow-up

Exclusion criteria

  • Patient with a restriction to the practice of moderate physical activity or bicycle (acute coronary disease of less than 2 years, locomotor problem)
  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons), pregnant, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a legal protection measure

Treatment and study plan

Intelligent electric bicycle (VELIS) sessions

Other

Oncology patients will participate in intelligent electric bicycle (VELIS) sessions twice a week for 6 weeks after their release from a rehabilitation and recuperative care facility

Primary outcomes

  1. Percentage of patients reaching the goal of 150 min equivalent of moderate physical activity per week (600 MET-min/week)

    Time frame: 4 Months

    Evaluated with the IPAQ questionnaire short version (International Physical Activity Questionnaire)

Secondary outcomes

  1. Quantitative analysis of kinetic physical activity evolution

    Time frame: Enrollment and then once a month from Month 2 to Month 4, the last week of the month, velis sessions and effort retraining excluded

    Longitudinal continue quantitative data from IPAQ score

  2. Evaluate the VELIS sessions feasibility n°1

    Time frame: 4 Months

    Number of cancelled sessions

  3. Evaluate the VELIS sessions feasibility n°2

    Time frame: 4 Months

    Number of incomplete sessions

  4. Evaluate the VELIS sessions feasibility n°3

    Time frame: 4 Months

    Collection of the failure reasons by the instructor

  5. Evaluate the impact on the physical capacities n°1

    Time frame: 4 Months

    Progression of the patients physical activity (clinical exam weight)

  6. Evaluate the impact on the physical capacities n°2

    Time frame: 4 Months

    Progression of the patients physical activity (heart rate)

  7. Evaluate the impact on the physical capacities n°3

    Time frame: 4 Months

    Progression of the patients physical activity (analysis of physio-cardiological criteria)

  8. Evaluate the impact on the physical capacities n°4

    Time frame: 4 Months

    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (initial gain in effort retraining)

  9. Evaluate the impact on the physical capacities n°5

    Time frame: 4 Months

    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (age)

  10. Evaluate the impact on the physical capacities n°6

    Time frame: 4 Months

    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (gender)

  11. Evaluate the impact on the physical capacities n°7

    Time frame: 4 Months

    Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (pathologies)

  12. Evaluate the impact on the physical capacities n°8

    Time frame: 4 Months

    Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (endurance test on ergocycle)

  13. Evaluate the impact on the physical capacities n°9

    Time frame: 4 Months

    Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (evaluation with the quantitative Borg scale (from Pr Gunnar BORG) from 0 to 10 (the goal score is 4 to 5)).

  14. Evaluate the impact on the physical capacities n°10

    Time frame: 4 Months

    Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (heart rate)

  15. Evaluate the impact on the physical capacities n°11

    Time frame: 4 Months

    Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (visual analogical scale from 0 (no pain) to 10 (maximal pain) for the lower limbs pain. Lower value is a better outcome)

  16. Evaluate the impact on the physical capacities n°12

    Time frame: 4 Months

    Measurement of the muscular power using a handgrip (physiological parameter). Higher value is a better outcome.

  17. Improve quality of life

    Time frame: 4 Months

    Euroquol 5 dimensions scale (from 0 to 100 : higher value is a better outcome)

  18. Improve fatigue n°1

    Time frame: 4 Months

    Analogic visual scale about fatigue once a month

  19. Improve fatigue n°2

    Time frame: 4 Months

    Fatigue Piper score

  20. Improve chronic pain

    Time frame: 4 Months

    Analogic visual scale about pain once a month

  21. Improve self-esteem

    Time frame: 4 Months

    Evaluation with Rosenberg score

  22. Improve patient satisfaction

    Time frame: 4 Months

    Satisfaction survey and wish to do again intelligent electric bicycle (VELIS) sessions or to continue electric bicycle sessions

  23. Remove stereotypes that can lead to inhibition in the physical activity practice

    Time frame: 4 Months

    Evaluation of the psychological representation of physical activity using the Cancer Exercise Stereotypes Scale (CESS) questionnaire from the SENS (sport and social environment laboratory) team from Grenoble.

    The average value is calculated for each subscale.

    Adherence to positive stereotypes if value is below 4 for the following subscale :

    • Lack of interest in physical activity (items 1, 6, 11)
    • Side effects related to treatment (items 3, 8, 13, 17)
    • Risks related to physical activity (items 5, 10, 15) Adherence to positive stereotypes if value is greater than 4 for the subscale Benefits of physical activity (items 4, 9, 14, 18).

  24. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°1

    Time frame: 6 weeks

    Analysis of the parameters profiles recorded by the VELIS : heart rate monitor

  25. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°2

    Time frame: 6 weeks

    Analysis of the parameters profiles recorded by the VELIS : speed

  26. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°3

    Time frame: 6 weeks

    Analysis of the parameters profiles recorded by the VELIS : electric power provided by the engine

  27. Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°4

    Time frame: 6 weeks

    Analysis of the parameters profiles recorded by the VELIS : rate of pedaling for the reference itinerary

Sponsors and collaborators

Lead sponsor

Fondation Audavie

Other

Collaborators

  • Floralis
  • Rocheplane Medical Center
  • eBikeLabs

Registry information

Official study title

Evaluation of the Use of an Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity After a Stay for Effort Retraining in Rehabilitation and Recuperative Care Facilities for Oncology Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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