HealthyNCT00428779
Neuromuscular and Cognitive Fatigue During a 24 Hour Treadmill Running Exercise
A study testing running during 24 hours without sleep and no sleeping in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- running during 24 hours without sleep and no sleeping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Dec 2007
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects of the experimental group will be recruited among experienced ultra-runners . They all have run at least a 12 hour race or longer.
- The control group will be recruited among experienced ultra-runners . Age of control group will be age experimental group more or less 2 years.
Who cannot join
- The subjects will not be selected if:
- they were injured in the 3 months before the experiment
- they had a tendon or joint pathology that could impair strength measurements.
- they participate to an other experiment at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular and Cognitive Fatigue During a 24h Treadmill Running Exercise.
The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.
Read the detailed description
For that purpose, 14 subjects running 24 hours on a treadmill will be compared with a control group being awake during the same period. Subjects who running will have electrically evoked forces on the muscles associated EMG activity, blood samples and muscle biopsy.
- Conditions
- Healthy
- Being tested
- running during 24 hours without sleep, no sleeping
- Keywords
- Running during 24 hours, Voluntary evoked force on the muscles, Electrically evoked force on the muscles, EMG activity, Muscle biopsy, subjects will be recruited among experienced ultra-runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
running during 24 hours without sleepProcedure or surgery
patients running during 24 hours without sleep
no sleepingOther
patients without sleep during 24 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients running during 24 hours without sleep Receives: Procedure: running during 24 hours without sleep |
| 2 | Placebo comparator | patients without sleep during 24 hours Receives: Other: no sleeping |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Voluntary and electrically evoked forces on the contracted muscles
Measured: 24 hours
Secondary outcomes (3)
Electrically evoked forces on the relaxed muscles and associated EMG activity
Measured: 24 hours
Blood samples before the exercise
Measured: every 4 hours
Muscle biopsy (vastus lateralis)
Measured: before and after the exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- DENIS Christian, Professor, Study chair, Service de médecine du sport, CHU SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428779
- Sponsor's protocol ID
- 0601095
- Other IDs
- DGS 2006-0111, 2006-A00312-49
- Status last verified
- Jun 2009
- First submitted
- 29 Jan 2007
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Morin JB, Samozino P, Feasson L, Geyssant A, Millet G. Effects of muscular biopsy on the mechanics of running. Eur J Appl Physiol. 2009 Jan;105(2):185-90. doi: 10.1007/s00421-008-0888-2. Epub 2008 Oct 8.
PubMed 18841378Jamart C, Francaux M, Millet GY, Deldicque L, Frere D, Feasson L. Modulation of autophagy and ubiquitin-proteasome pathways during ultra-endurance running. J Appl Physiol (1985). 2012 May;112(9):1529-37. doi: 10.1152/japplphysiol.00952.2011. Epub 2012 Feb 16.
PubMed 22345427
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular and Cognitive Fatigue During a 24h Treadmill Running Exercise.
- ClinicalTrials.gov ID
- NCT00428779
- Acronym / sponsor ID
- 0601095
- Conditions
- Healthy
- Keywords
- Running during 24 hours, Voluntary evoked force on the muscles, Electrically evoked force on the muscles, EMG activity, Muscle biopsy, subjects will be recruited among experienced ultra-runners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Jan 2007 (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.
The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.
Detailed description
For that purpose, 14 subjects running 24 hours on a treadmill will be compared with a control group being awake during the same period. Subjects who running will have electrically evoked forces on the muscles associated EMG activity, blood samples and muscle biopsy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: running during 24 hours without sleeppatients running during 24 hours without sleep |
| 2 | Placebo comparator | Other: no sleepingpatients without sleep during 24 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The subjects of the experimental group will be recruited among experienced ultra-runners . They all have run at least a 12 hour race or longer.
- The control group will be recruited among experienced ultra-runners . Age of control group will be age experimental group more or less 2 years.
Key exclusion criteria (4 listed)
- The subjects will not be selected if:
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 |
|---|---|---|
| running during 24 hours without sleeppatients running during 24 hours without sleep | Procedure or surgery | 1 |
| no sleepingpatients without sleep during 24 hours | Other | 2 |
Primary outcome
-Voluntary and electrically evoked forces on the contracted muscles
Time frame: 24 hours
3 secondary outcomes
Electrically evoked forces on the relaxed muscles and associated EMG activity
Time frame: 24 hours
Blood samples before the exercise
Time frame: every 4 hours
Muscle biopsy (vastus lateralis)
Time frame: before and after the exercise
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 11 Jun 2009.
- Results publication: PubMed 18841378Morin JB, Samozino P, Feasson L, Geyssant A, Millet G. Effects of muscular biopsy on the mechanics of running. Eur J Appl Physiol. 2009 Jan;105(2):185-90. doi: 10.1007/s00421-008-0888-2. Epub 2008 Oct 8.
- Derived from this study: PubMed 22345427Jamart C, Francaux M, Millet GY, Deldicque L, Frere D, Feasson L. Modulation of autophagy and ubiquitin-proteasome pathways during ultra-endurance running. J Appl Physiol (1985). 2012 May;112(9):1529-37. doi: 10.1152/japplphysiol.00952.2011. Epub 2012 Feb 16.
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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.
DENIS Christian, Professor study chair
Service de médecine du sport, CHU SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing running during 24 hours without sleep and no sleeping in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 inclusion and 4 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 11 Jun 2009. 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. Some participants in this study may receive a placebo. 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?
-Voluntary and electrically evoked forces on the contracted muscles (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00428779, which also lists 2 linked publications.
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 11 Jun 2009.