NCT02070848

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
4.5 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

February 14, 2014

Last Update Submit

March 4, 2021

Conditions

Keywords

red blood cellknee extension exercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (1)

Concentric vs eccentric

One arm study in which each subject will act as his own control.

Other: Session 1-4Other: Session 4Other: Session 5

Interventions

Familiarization sessions to knee-extensor exercise separated by 72h recovery

Concentric vs eccentric

After the last familiarization session, 1 maximal incremental test on a bicycle, followed by 72h rest

Concentric vs eccentric

2 maximal incremental tests of knee-extension exercise (concentric vs eccentric), separated by 3h rest.

Concentric vs eccentric

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be students recruited in the Faculty, sports clubs...

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SERVICE DE PHYSIOLOGIE ET D'EXPLORATIONS FONCTIONNELLES - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Study Officials

  • Stéphane DOUTRELEAU, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR
  • DUFOUR Stéphane, MD

    Faculté des Sciences du Sport 14 Rue René Descartes 67084 Strasbourg

    STUDY DIRECTOR
  • FAVRET Fabrice, MD

    Faculté des Sciences du Sport 14 Rue René Descartes 67084 Strasbourg

    STUDY CHAIR
  • LONSDORFER Evelyne, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 25, 2014

Study Start

September 1, 2018

Primary Completion

October 19, 2018

Study Completion

October 19, 2018

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations