NCT03340857

Brief 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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

September 27, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

September 27, 2017

Last Update Submit

February 4, 2020

Conditions

CancerOncology

Keywords

Post-cancer retrainingPhysical activityIntelligent electric bicycle

Outcome Measures

Primary Outcomes (1)

  • 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)

    4 Months

Secondary Outcomes (27)

  • Quantitative analysis of kinetic physical activity evolution

    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

    4 Months

  • Evaluate the VELIS sessions feasibility n°2

    4 Months

  • Evaluate the VELIS sessions feasibility n°3

    4 Months

  • Evaluate the impact on the physical capacities n°1

    4 Months

  • +22 more secondary outcomes

Study Arms (1)

Intelligent electric bicycle (VELIS) sessions

EXPERIMENTAL

Intelligent electric bicycle (VELIS) sessions with an instructor, twice a week for 6 weeks

Other: Intelligent electric bicycle (VELIS) sessions

Interventions

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

Intelligent electric bicycle (VELIS) sessions

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocheplane Medical Center

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

Location

Related Publications (11)

  • 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.

    PMID: 24599577BACKGROUND

  • 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

  • Nelson 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.

    PMID: 17762378BACKGROUND

  • Mielgo-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.

    PMID: 26914609BACKGROUND

  • 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

  • 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

  • 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

  • Simons 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.

    PMID: 19812505BACKGROUND

  • Falzon 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.

    PMID: 25174265BACKGROUND

  • Piper 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.

    PMID: 9599351BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jean-Luc Bosson, MD

    Laboratoire TIMC - Themas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

November 14, 2017

Study Start

October 9, 2017

Primary Completion

October 30, 2018

Study Completion

December 30, 2018

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

FR(1)