NCT05166148

Brief Summary

This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:

  • Session (a): eccentric cycling
  • Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
  • Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable breast-cancer

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

Study Start

First participant enrolled

November 22, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

November 24, 2021

Last Update Submit

May 25, 2022

Conditions

Breast Cancer

Keywords

Breast CancerEccentric CyclingPhysiological Responses

Outcome Measures

Primary Outcomes (1)

  • Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters

    Measurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.

    24 hours after pedaling sessions

Secondary Outcomes (8)

  • Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)

    24 hours after pedaling sessions

  • Comparison of central (identified as a decrease in voluntary activation, VA) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)

    24 hours after pedaling sessions

  • Comparison of peripheral (identified as a decrease in the quadriceps twitch muscle contractile capacities, Qtw) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)

    24 hours after pedaling sessions

  • Comparison of muscle thickness measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)

    24 hours after pedaling sessions

  • Comparison of muscle fibers pennation angle measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)

    24 hours after pedaling sessions

  • +3 more secondary outcomes

Study Arms (1)

eccentric cycling compared to concentric cycling

EXPERIMENTAL

Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention.

Other: Session (a)Other: Session (b)Other: Session (c)

Interventions

Session (a)OTHER

Eccentric cycling

eccentric cycling compared to concentric cycling
Session (b)OTHER

High intensity concentric cycling realized at the same mechanical power output than eccentric cycling

eccentric cycling compared to concentric cycling
Session (c)OTHER

Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling

eccentric cycling compared to concentric cycling

Eligibility Criteria

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

You may qualify if:

  • Woman who completed (neo)adjuvant chemotherapy since less than 1 year for a breast cancer
  • Woman under hormonotherapy, or menopausal woman, or woman in amenorrhea

You may not qualify if:

  • Pregnant and nursing woman
  • psychiatric, musculoskeletal or neurological disorders
  • presenting at least one contraindication to the use of the transcranial magnetic stimulation
  • presenting at least one contraindication to the realisation of the maximum effort test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Roland SCHOTT, MD

    Institut de cancérologie Strasbourg Europe

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 21, 2021

Study Start

November 22, 2021

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

FR(1)