Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients (PROTECT-05)
25 maj 2022 uppdaterad av: Institut de cancérologie Strasbourg Europe
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Strasbourg, Frankrike
- Institut de cancérologie Strasbourg Europe
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: eccentric cycling compared to concentric cycling
Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention.
|
Eccentric cycling
High intensity concentric cycling realized at the same mechanical power output than eccentric cycling
Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters
Tidsram: 24 hours after pedaling sessions
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Tidsram: 24 hours after pedaling sessions
|
Measurement 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).
|
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)
Tidsram: 24 hours after pedaling sessions
|
Measurement 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).
|
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)
Tidsram: 24 hours after pedaling sessions
|
Measurement of peripheral fatigue by percutaneous neurostimulation applied at rest to evoked quadriceps twitch force (Qtw) to evidence muscle contractile properties.
|
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)
Tidsram: 24 hours after pedaling sessions
|
Change 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.
|
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)
Tidsram: 24 hours after pedaling sessions
|
Change 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.
|
24 hours after pedaling sessions
|
|
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)
Tidsram: 24 hours after pedaling sessions
|
Change 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.
|
24 hours after pedaling sessions
|
|
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)
Tidsram: 24 hours after pedaling sessions
|
Change 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.
|
24 hours after pedaling sessions
|
|
Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)
Tidsram: 24 hours after pedaling sessions
|
Change 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).
|
24 hours after pedaling sessions
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Roland SCHOTT, MD, Institut de cancérologie Strasbourg Europe
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 november 2021
Primärt slutförande (Faktisk)
28 april 2022
Avslutad studie (Faktisk)
28 april 2022
Studieregistreringsdatum
Först inskickad
24 november 2021
Först inskickad som uppfyllde QC-kriterierna
8 december 2021
Första postat (Faktisk)
21 december 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021-005
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .