CancerNCT03340857
Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity for Oncology Patients
A study testing Intelligent electric bicycle (VELIS) sessions in people with Cancer and Oncology, run by Fondation Audavie at 1 site in France.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Intelligent electric bicycle (VELIS) sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Rocheplane Medical Center
Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, 38400
About this study
Official 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
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)
Read the detailed description
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.
- Being tested
- Intelligent electric bicycle (VELIS) sessions
- Keywords
- Post-cancer retraining, Physical activity, Intelligent electric bicycle
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent electric bicycle (VELIS) sessionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intelligent electric bicycle (VELIS) sessions | Experimental | Intelligent electric bicycle (VELIS) sessions with an instructor, twice a week for 6 weeks Receives: Other: Intelligent electric bicycle (VELIS) sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients reaching the goal of 150 min equivalent of moderate physical activity per week (600 MET-min/week)
Evaluated with the IPAQ questionnaire short version (International Physical Activity Questionnaire)
Measured: 4 Months
Secondary outcomes (27)
Quantitative analysis of kinetic physical activity evolution
Longitudinal continue quantitative data from IPAQ score
Measured: Enrollment and then once a month from Month 2 to Month 4, the last week of the month, velis sessions and effort retraining excluded
Evaluate the VELIS sessions feasibility n°1
Number of cancelled sessions
Measured: 4 Months
Evaluate the VELIS sessions feasibility n°2
Number of incomplete sessions
Measured: 4 Months
Evaluate the VELIS sessions feasibility n°3
Collection of the failure reasons by the instructor
Measured: 4 Months
Evaluate the impact on the physical capacities n°1
Progression of the patients physical activity (clinical exam weight)
Measured: 4 Months
Evaluate the impact on the physical capacities n°2
Progression of the patients physical activity (heart rate)
Measured: 4 Months
Evaluate the impact on the physical capacities n°3
Progression of the patients physical activity (analysis of physio-cardiological criteria)
Measured: 4 Months
Evaluate the impact on the physical capacities n°4
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (initial gain in effort retraining)
Measured: 4 Months
Evaluate the impact on the physical capacities n°5
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (age)
Measured: 4 Months
Evaluate the impact on the physical capacities n°6
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (gender)
Measured: 4 Months
Evaluate the impact on the physical capacities n°7
Analysis of the progression during intelligent electric bicycle (VELIS) sessions with associated factors (pathologies)
Measured: 4 Months
Evaluate the impact on the physical capacities n°8
Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (endurance test on ergocycle)
Measured: 4 Months
Evaluate the impact on the physical capacities n°9
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)).
Measured: 4 Months
Evaluate the impact on the physical capacities n°10
Constant-Load Exercise Test at 80% MAP (Maximum Aerobic Power) (heart rate)
Measured: 4 Months
Evaluate the impact on the physical capacities n°11
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)
Measured: 4 Months
Evaluate the impact on the physical capacities n°12
Measurement of the muscular power using a handgrip (physiological parameter). Higher value is a better outcome.
Measured: 4 Months
Improve quality of life
Euroquol 5 dimensions scale (from 0 to 100 : higher value is a better outcome)
Measured: 4 Months
Improve fatigue n°1
Analogic visual scale about fatigue once a month
Measured: 4 Months
Improve fatigue n°2
Fatigue Piper score
Measured: 4 Months
Improve chronic pain
Analogic visual scale about pain once a month
Measured: 4 Months
Improve self-esteem
Evaluation with Rosenberg score
Measured: 4 Months
Improve patient satisfaction
Satisfaction survey and wish to do again intelligent electric bicycle (VELIS) sessions or to continue electric bicycle sessions
Measured: 4 Months
Remove stereotypes that can lead to inhibition in the physical activity practice
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).
Measured: 4 Months
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°1
Analysis of the parameters profiles recorded by the VELIS : heart rate monitor
Measured: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°2
Analysis of the parameters profiles recorded by the VELIS : speed
Measured: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°3
Analysis of the parameters profiles recorded by the VELIS : electric power provided by the engine
Measured: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°4
Analysis of the parameters profiles recorded by the VELIS : rate of pedaling for the reference itinerary
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start9 Oct 2017
- Primary completion30 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Audavie
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis, eBikeLabs, Rocheplane Medical Center
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Bosson, MD, Principal investigator, Laboratoire TIMC - Themas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340857
- Sponsor's protocol ID
- ONCOVELIS version 2.0
- Status last verified
- Feb 2020
- First submitted
- 27 Sep 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Phillips SM, Alfano CM, Perna FM, Glasgow RE. Accelerating translation of physical activity and cancer survivorship research into practice: recommendations for a more integrated and collaborative approach. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):687-99. doi: 10.1158/1055-9965.EPI-13-1355. Epub 2014 Mar 5.
PubMed 24599577Haskell 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.
PubMed 17671237Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
PubMed 17762378Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Avila JM, Aranceta-Batrina J, Gil A, Ortega RM, Serra-Majem L, Varela-Moreiras G, Gonzalez-Gross M. Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study. PLoS One. 2016 Feb 25;11(2):e0149969. doi: 10.1371/journal.pone.0149969. eCollection 2016.
PubMed 26914609Pavey 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.
PubMed 22182828Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.
PubMed 22913003Peterman 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.
PubMed 27299435Gojanovic 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.
PubMed 22005715Simons M, Van Es E, Hendriksen I. Electrically assisted cycling: a new mode for meeting physical activity guidelines? Med Sci Sports Exerc. 2009 Nov;41(11):2097-102. doi: 10.1249/MSS.0b013e3181a6aaa4.
PubMed 19812505Falzon C, Sabiston C, Bergamaschi A, Corrion K, Chalabaev A, D'Arripe-Longueville F. Development and validation of the Cancer Exercise Stereotypes Scale. J Psychosoc Oncol. 2014;32(6):708-26. doi: 10.1080/07347332.2014.955237.
PubMed 25174265Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.
PubMed 9599351
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03340857
- Acronym / sponsor ID
- ONCOVELIS version 2.0
- Keywords
- Post-cancer retraining, Physical activity, Intelligent electric bicycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondation AudavieUniversity, hospital or other
- Collaborators
- Floralis, eBikeLabs, Rocheplane Medical Center
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intelligent electric bicycle (VELIS) sessions | Experimental | Other: Intelligent electric bicycle (VELIS) sessionsIntelligent electric bicycle (VELIS) sessions with an instructor, twice a week for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent electric bicycle (VELIS) sessionsOncology 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 | Other | Intelligent electric bicycle (VELIS) sessions |
Primary outcome
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)
27 secondary outcomes
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
Evaluate the VELIS sessions feasibility n°1
Time frame: 4 Months
Evaluate the VELIS sessions feasibility n°2
Time frame: 4 Months
Evaluate the VELIS sessions feasibility n°3
Time frame: 4 Months
Evaluate the impact on the physical capacities n°1
Time frame: 4 Months
Evaluate the impact on the physical capacities n°2
Time frame: 4 Months
Evaluate the impact on the physical capacities n°3
Time frame: 4 Months
Evaluate the impact on the physical capacities n°4
Time frame: 4 Months
Evaluate the impact on the physical capacities n°5
Time frame: 4 Months
Evaluate the impact on the physical capacities n°6
Time frame: 4 Months
Evaluate the impact on the physical capacities n°7
Time frame: 4 Months
Evaluate the impact on the physical capacities n°8
Time frame: 4 Months
Evaluate the impact on the physical capacities n°9
Time frame: 4 Months
Evaluate the impact on the physical capacities n°10
Time frame: 4 Months
Evaluate the impact on the physical capacities n°11
Time frame: 4 Months
Evaluate the impact on the physical capacities n°12
Time frame: 4 Months
Improve quality of life
Time frame: 4 Months
Improve fatigue n°1
Time frame: 4 Months
Improve fatigue n°2
Time frame: 4 Months
Improve chronic pain
Time frame: 4 Months
Improve self-esteem
Time frame: 4 Months
Improve patient satisfaction
Time frame: 4 Months
Remove stereotypes that can lead to inhibition in the physical activity practice
Time frame: 4 Months
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°1
Time frame: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°2
Time frame: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°3
Time frame: 6 weeks
Evolution of uses and performances during bicycle sessions at the beginning and the end of the intervention n°4
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 24599577Phillips SM, Alfano CM, Perna FM, Glasgow RE. Accelerating translation of physical activity and cancer survivorship research into practice: recommendations for a more integrated and collaborative approach. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):687-99. doi: 10.1158/1055-9965.EPI-13-1355. Epub 2014 Mar 5.
- Background: PubMed 17671237Haskell 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.
- Background: PubMed 17762378Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
- Background: PubMed 26914609Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Avila JM, Aranceta-Batrina J, Gil A, Ortega RM, Serra-Majem L, Varela-Moreiras G, Gonzalez-Gross M. Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study. PLoS One. 2016 Feb 25;11(2):e0149969. doi: 10.1371/journal.pone.0149969. eCollection 2016.
- Background: PubMed 22182828Pavey 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.
- Background: PubMed 22913003Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.
- Background: PubMed 27299435Peterman 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.
- Background: PubMed 22005715Gojanovic 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.
- Background: PubMed 19812505Simons M, Van Es E, Hendriksen I. Electrically assisted cycling: a new mode for meeting physical activity guidelines? Med Sci Sports Exerc. 2009 Nov;41(11):2097-102. doi: 10.1249/MSS.0b013e3181a6aaa4.
- Background: PubMed 25174265Falzon C, Sabiston C, Bergamaschi A, Corrion K, Chalabaev A, D'Arripe-Longueville F. Development and validation of the Cancer Exercise Stereotypes Scale. J Psychosoc Oncol. 2014;32(6):708-26. doi: 10.1080/07347332.2014.955237.
- Background: PubMed 9599351Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.
- 3rd report INCA february 2017Link provided by the sponsor.
- Evaluation of the impact on health. Promotion of the electrical bike. Final report. 2006Link provided by the sponsor.
- Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike JULY 6, 2016 6:00 AM July 6, 2016.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Bosson, MD principal investigator
Laboratoire TIMC - Themas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent electric bicycle (VELIS) sessions in people with Cancer and Oncology, run by Fondation Audavie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients reaching the goal of 150 min equivalent of moderate physical activity per week (600 MET-min/week) (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340857, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.