HealthyNCT00522561
Lower Limb Mechanical Characteristics: Effect on Running Mechanics and Energetics
A study testing energetic and non invasive limb mechanical measurements in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Inter-individual variability in energetic cost of running may be partly explained by lower limbs mechanical characteristics. The transposition of muscle mechanical model with two components (contractile and elastic) to the whole lower limb mechanical behavior analysis during running. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- energetic and non invasive limb mechanical measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Mar 2008
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men being between 20 and 35 years old and doing regularly physical activities
- subjects must be able to run at 12 km/h during 15 minutes in aerobic condition
- not be sedentary and not do running competitions
- be affiliated to a social security system
- Sign a written inform consent
Who cannot join
- presenting a clinic sign of intolerance to exercise, and particularly to running
- overweight subjects
- having a medical treatment which may interfere with the running quality or with one of the physiological parameters measured
- taking part at the same moment in another medicinal research
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Physiologie clinique et de l'exercice - CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Inter-individual variability in energetic cost of running may be partly explained by lower limbs mechanical characteristics. The transposition of muscle mechanical model with two components (contractile and elastic) to the whole lower limb mechanical behavior analysis during running. The main aim of present investigation is to study the effects of lower limb mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using a lower limb mechanical approach including both contractile and elastic components.Twenty healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through conditions, stride frequency, sole stiffness and subject's body weight will be changed to allow artificial variations in lower limb mechanical characteristics. Energetic and non-invasive mechanical measurements analysis will be performed to obtain energetic cost of running and to compute force, velocity and stiffness of lower limbs for each condition.
Read the detailed description
Main aim: Identify the effect of mechanical characteristic induced on lower limbs on the energetic cost of running.
Secondary aim : Minimize the energetic cost of running by lower limb mechanical characteristics optimization.
- Conditions
- Healthy
- Being tested
- energetic and non invasive limb mechanical measurements
- Keywords
- Healthy volunteers, running, energetic cost, limb mechanical characteristics, contractile components, elastic components, healthy men doing regularly physical activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energetic and non invasive limb mechanical measurementsOther
Force velocity stiffness running
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | healthy volunteers Receives: Other: energetic and non invasive limb mechanical measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
the energetic cost of running: the energetic cost (Oxygen consumption by meter covered) is calculated by the ratio of oxygen consumption on the running velocity.
Measured: within 4 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Roger OULLION, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522561
- Sponsor's protocol ID
- 0701039
- Other IDs
- 2007-A00562-51, DGS 2007-0360
- Status last verified
- Jun 2009
- First submitted
- 28 Aug 2007
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Mechanical Characteristics: Effect on Running Mechanics and Energetics
- ClinicalTrials.gov ID
- NCT00522561
- Acronym / sponsor ID
- 0701039
- Conditions
- Healthy
- Keywords
- Healthy volunteers, running, energetic cost, limb mechanical characteristics, contractile components, elastic components, healthy men doing regularly physical activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Aug 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.
Inter-individual variability in energetic cost of running may be partly explained by lower limbs mechanical characteristics. The transposition of muscle mechanical model with two components (contractile and elastic) to the whole lower limb mechanical behavior analysis during running. The main aim of present investigation is to study the effects of lower limb mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using a lower limb mechanical approach including both contractile and elastic components.Twenty healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through conditions, stride frequency, sole stiffness and subject's body weight will be changed to allow artificial variations in lower limb mechanical characteristics. Energetic and non-invasive mechanical measurements analysis will be performed to obtain energetic cost of running and to compute force, velocity and stiffness of lower limbs for each condition.
Detailed description
Main aim: Identify the effect of mechanical characteristic induced on lower limbs on the energetic cost of running.
Secondary aim : Minimize the energetic cost of running by lower limb mechanical characteristics optimization.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: energetic and non invasive limb mechanical measurementshealthy volunteers |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy men being between 20 and 35 years old and doing regularly physical activities
- subjects must be able to run at 12 km/h during 15 minutes in aerobic condition
- not be sedentary and not do running competitions
- be affiliated to a social security system
- Sign a written inform consent
Key exclusion criteria (4 listed)
- presenting a clinic sign of intolerance to exercise, and particularly to running
- overweight subjects
- having a medical treatment which may interfere with the running quality or with one of the physiological parameters measured
- taking part at the same moment in another medicinal research
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 |
|---|---|---|
| energetic and non invasive limb mechanical measurementsForce velocity stiffness running | Other | 1 |
Primary outcome
the energetic cost of running: the energetic cost (Oxygen consumption by meter covered) is calculated by the ratio of oxygen consumption on the running velocity.
Time frame: within 4 weeks after inclusion
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 12 Jun 2009.
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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.
Roger OULLION, MD PhD principal investigator
CHU de 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 energetic and non invasive limb mechanical measurements 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 5 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 12 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. 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?
the energetic cost of running: the energetic cost (Oxygen consumption by meter covered) is calculated by the ratio of oxygen consumption on the running velocity. (time frame: within 4 weeks after inclusion). 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 12 Jun 2009.