Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients (PROTECT-05)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Session (a)
Session (b)
Session (c)
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer focused on measuring Breast Cancer, Eccentric Cycling, Physiological Responses
Eligibility Criteria
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
Sites / Locations
- Institut de cancérologie Strasbourg Europe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eccentric cycling compared to concentric cycling
Arm Description
Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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.
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT05166148
First Posted
November 24, 2021
Last Updated
May 25, 2022
Sponsor
Institut de cancérologie Strasbourg Europe
1. Study Identification
Unique Protocol Identification Number
NCT05166148
Brief Title
Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients
Acronym
PROTECT-05
Official Title
Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de cancérologie Strasbourg Europe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Eccentric Cycling, Physiological Responses
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eccentric cycling compared to concentric cycling
Arm Type
Experimental
Arm Description
Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention.
Intervention Type
Other
Intervention Name(s)
Session (a)
Intervention Description
Eccentric cycling
Intervention Type
Other
Intervention Name(s)
Session (b)
Intervention Description
High intensity concentric cycling realized at the same mechanical power output than eccentric cycling
Intervention Type
Other
Intervention Name(s)
Session (c)
Intervention Description
Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling
Primary Outcome Measure Information:
Title
Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters
Description
Measurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.
Time Frame
24 hours after pedaling sessions
Secondary Outcome Measure Information:
Title
Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)
Description
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).
Time Frame
24 hours after pedaling sessions
Title
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)
Description
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).
Time Frame
24 hours after pedaling sessions
Title
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)
Description
Measurement of peripheral fatigue by percutaneous neurostimulation applied at rest to evoked quadriceps twitch force (Qtw) to evidence muscle contractile properties.
Time Frame
24 hours after pedaling sessions
Title
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)
Description
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.
Time Frame
24 hours after pedaling sessions
Title
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)
Description
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.
Time Frame
24 hours after pedaling sessions
Title
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)
Description
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.
Time Frame
24 hours after pedaling sessions
Title
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)
Description
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.
Time Frame
24 hours after pedaling sessions
Title
Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)
Description
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).
Time Frame
24 hours after pedaling sessions
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland SCHOTT, MD
Organizational Affiliation
Institut de cancérologie Strasbourg Europe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de cancérologie Strasbourg Europe
City
Strasbourg
Country
France
12. IPD Sharing Statement
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Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients
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