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Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients

Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05166148
Acronym
PROTECT-05
Enrollment
12
Registered
2021-12-21
Start date
2021-11-22
Completion date
2022-04-28
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Eccentric Cycling, Physiological Responses

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.

Detailed description

For each participant, 10 visits will be realized as followed: Visit 1: determination of maximal O2 consumption (VO2max) and first familiarization session to eccentric cycling Visits 2, 3 and 4: second, third and fourth eccentric cycling familiarization sessions Visits 5, 7 and 9: cycling sessions (a), (b) and (c) attributed in a random order Visits 6, 8 and 10: post-24h measurements after cycling sessions

Interventions

OTHERSession (a)

Eccentric cycling

OTHERSession (b)

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

OTHERSession (c)

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

Sponsors

Institut de cancérologie Strasbourg Europe
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters24 hours after pedaling sessionsMeasurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.

Secondary

MeasureTime frameDescription
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 sessionsMeasurement of central fatigue by percutaneous neurostimulation applied during the maximal voluntary contraction to evidence the level of voluntary activation (VA in %) and by transcranial magnetic stimulation to evidenced level of corticospinal excitability (measured by the MEP visible on EMG activity).
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 sessionsMeasurement of peripheral fatigue by percutaneous neurostimulation applied at rest to evoked quadriceps twitch force (Qtw) to evidence muscle contractile properties.
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 sessionsChange from baseline by ultrasonography measurements in the muscle thickness of the vastus lateralis muscle. Muscle thickness was measured as the distance from the superior border of the superficial aponeurosis and the superior border of the deep aponeurosis.
Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)24 hours after pedaling sessionsMeasurement of muscle pain by visual analog scale (VAS) consists of a 100 mm long line providing a range of score from 0-100 (0: no pain, 100: worst possible pain).
Comparison of muscle fibers fascile length 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 sessionsChange from baseline by ultrasonography measurements in the fascicle length of the vastus lateralis muscle. Fascicle length was measured as the distance of a fibers between its insertion on the superficial aponeurosis and its insertions on the deep aponeurosis.
Comparison of muscle echogenecity 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 sessionsChange from baseline by ultrasonography measurements in echogenecity of the vastus lateralis muscle. Echo intensity was determined based on the gray scale analysis of each pixel, the corresponding index of muscle quality ranging between 0 and 255 arbitrary units.
Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)24 hours after pedaling sessionsChange from baseline of blood markers dosage. Blood markers dosage investigated will: Reactive oxygen species (ROS), carbonylated protein, lipid peroxidation, antioxidant enzyme, proinflammatory cytokines, and muscle damage markers (creatine kinase, lactate dehydrogenase).
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 sessionsChange from baseline by ultrasonography measurements in the pennation angle of the vastus lateralis muscle. Pennation angle was measured as the angle between a fiber and the deep aponeurosis.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026