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

Breast Cancer Clinical Trial

— PROTECT-05  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166148
• Other study ID #: 2021-005
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: May 2022
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)	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
Secondary	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)	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
Secondary	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)	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
Secondary	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)	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
Secondary	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)	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
Secondary	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)	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
Secondary	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)	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
Secondary	Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)	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