Skeletal Muscle Blood FlowNCT02070848
Muscle Blood Flow During Exercise
An observational study of Skeletal Muscle Blood Flow, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Physical exercise triggers various physiological responses including a marked increase in muscle blood flow and oxygen delivery in order to support muscle activity. How muscle blood flow is controlled is currently unclear. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Blood Flow
- What is being tested?
- Session 1-4, Session 4 and Session 5
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 19 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Subjects will be students recruited in the Faculty, sports clubs...
Who may be able to join
- Non smoker or having stopped smoking for at least 5 yr
- Practice sports: physical activity level will be evaluated with a questionnaire (de Baecke et coll., 1982) and will give an activity index greater than 6 together with a VO2max greater than 50 ml/kg/min
- Body mass index lower than 25
- Registered to the French Social Security system
- Providing a written and informed consent to participate in the study
Who cannot join
- History of venous or arterial thrombo-embolic events
- Bad perfusion from the cubital artery
- Unable to understand the information notice
- Subject exposed to law investigations or with financial dependancy
- Subjects feeling unwell whan seing blood.
- Subjects advised to not practice sport.
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- Musculo-tendinous or articular issues with the lower leg
- Respiratory, cardiovascular or metabolic pathologies
- Current medical treatment that can not be stopped 7 days before the experiment.
Trial locations and contacts
1 site in 1 country.
France1 site
SERVICE DE PHYSIOLOGIE ET D'EXPLORATIONS FONCTIONNELLES - Nouvel Hôpital Civil
Strasbourg, 67091
About this study
Official title: Muscle Blood Flow Control During Exercise in Humans: Contribution From Mechanical and Metabolic Signals and Role of the Erythrocyte.
Physical exercise triggers various physiological responses including a marked increase in muscle blood flow and oxygen delivery in order to support muscle activity. How muscle blood flow is controlled is currently unclear.
The primary purpose of this study is to establish the respective contribution of metabolic (linked to energy requirements) and mechanical (linked to muscle tensions) signals in the exercise hyperemia and the possible role of the red blood cells.
Vasodilation and muscle blood flow during exercise are controlled by ATP released in the plasma from the red blood cells in response to a combination of metabolic and mechanical signals applied on the vasculature.
- Conditions
- Skeletal Muscle Blood Flow
- Being tested
- Session 1-4, Session 4, Session 5
- Keywords
- red blood cell, knee extension exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session 1-4Other
Familiarization sessions to knee-extensor exercise separated by 72h recovery
Session 4Other
After the last familiarization session, 1 maximal incremental test on a bicycle, followed by 72h rest
Session 5Other
2 maximal incremental tests of knee-extension exercise (concentric vs eccentric), separated by 3h rest.
| Study group | Role | What they receive |
|---|---|---|
| Concentric vs eccentric | One arm study in which each subject will act as his own control. Receives: Other: Session 1-4; Other: Session 4; Other: Session 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leg blood flow during concentric and eccentric muscle work
Serial measures (9) of leg blood flow during concentric and eccentric muscle work are performed at the beginning of the exercise (t0), and then after 14 minutes (t14), after 18 minutes (t18), after 22 minutes (t22), after 26 minutes (t26), after 30 minutes (t30), after 33 minutes (t33), after 35 minutes (t35), and after 45 minutes (45) during each exercice, concentric and eccentric.
Measured: Leg blood flow measurements during exercises performed at the beginning, after 14 minutes, then after 18 min, 22 min, 26 min, 30 min, 33 min, 35 min and 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study start1 Sep 2018
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle Blood FlowStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane DOUTRELEAU, MD, Principal investigator, Hôpitaux Universitaires de StrasbourgDUFOUR Stéphane, MD, Study director, Faculté des Sciences du Sport 14 Rue René Descartes 67084 StrasbourgFAVRET Fabrice, MD, Study chair, Faculté des Sciences du Sport 14 Rue René Descartes 67084 StrasbourgLONSDORFER Evelyne, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070848
- Sponsor's protocol ID
- 5456
- Status last verified
- Mar 2021
- First submitted
- 14 Feb 2014
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Blood Flow Control During Exercise in Humans: Contribution From Mechanical and Metabolic Signals and Role of the Erythrocyte.
- ClinicalTrials.gov ID
- NCT02070848
- Acronym / sponsor ID
- 5456
- Conditions
- Skeletal Muscle Blood Flow
- Keywords
- red blood cell, knee extension exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical exercise triggers various physiological responses including a marked increase in muscle blood flow and oxygen delivery in order to support muscle activity. How muscle blood flow is controlled is currently unclear.
The primary purpose of this study is to establish the respective contribution of metabolic (linked to energy requirements) and mechanical (linked to muscle tensions) signals in the exercise hyperemia and the possible role of the red blood cells.
Vasodilation and muscle blood flow during exercise are controlled by ATP released in the plasma from the red blood cells in response to a combination of metabolic and mechanical signals applied on the vasculature.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concentric vs eccentric | – | Other: Session 1-4, Other: Session 4, Other: Session 5One arm study in which each subject will act as his own control. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be students recruited in the Faculty, sports clubs...
Key inclusion criteria (5 listed)
- Non smoker or having stopped smoking for at least 5 yr
- Practice sports: physical activity level will be evaluated with a questionnaire (de Baecke et coll., 1982) and will give an activity index greater than 6 together with a VO2max greater than 50 ml/kg/min
- Body mass index lower than 25
- Registered to the French Social Security system
- Providing a written and informed consent to participate in the study
Key exclusion criteria (9 listed)
- History of venous or arterial thrombo-embolic events
- Bad perfusion from the cubital artery
- Unable to understand the information notice
- Subject exposed to law investigations or with financial dependancy
- Subjects feeling unwell whan seing blood.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Session 1-4Familiarization sessions to knee-extensor exercise separated by 72h recovery | Other | Concentric vs eccentric |
| Session 4After the last familiarization session, 1 maximal incremental test on a bicycle, followed by 72h rest | Other | Concentric vs eccentric |
| Session 52 maximal incremental tests of knee-extension exercise (concentric vs eccentric), separated by 3h rest. | Other | Concentric vs eccentric |
Primary outcome
Change in leg blood flow during concentric and eccentric muscle work
Time frame: Leg blood flow measurements during exercises performed at the beginning, after 14 minutes, then after 18 min, 22 min, 26 min, 30 min, 33 min, 35 min and 45 min
Serial measures (9) of leg blood flow during concentric and eccentric muscle work are performed at the beginning of the exercise (t0), and then after 14 minutes (t14), after 18 minutes (t18), after 22 minutes (t22), after 26 minutes (t26), after 30 minutes (t30), after 33 minutes (t33), after 35 minutes (t35), and after 45 minutes (45) during each exercice, concentric and eccentric.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane DOUTRELEAU, MD principal investigator
Hôpitaux Universitaires de Strasbourg
DUFOUR Stéphane, MD study director
Faculté des Sciences du Sport 14 Rue René Descartes 67084 Strasbourg
FAVRET Fabrice, MD study chair
Faculté des Sciences du Sport 14 Rue René Descartes 67084 Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skeletal Muscle Blood Flow, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in leg blood flow during concentric and eccentric muscle work (time frame: Leg blood flow measurements during exercises performed at the beginning, after 14 minutes, then after 18 min, 22 min, 26 min, 30 min, 33 min, 35 min and 45 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021; AzTrials last refreshed its copy on 5 Nov 2026.