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Maximum Voluntary ContractionForceGeneratioNCT02850328

Muscular Force Generation in Microgravity

A study testing examination of muscle function and MVC in weightlessness in people with Maximum Voluntary Contraction, run by University Hospital, Caen at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to evaluate the applicability of high-load resistance training as a countermeasure for long term space flights, the current project has two scientific goals. The main objective is to perform a deeper examination of muscle function and MVC in weightlessness (parabolic flight). Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Maximum Voluntary Contraction
What is being tested?
examination of muscle function and MVC in weightlessness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteFrance
Study dates
Sep 2014to Oct 2017
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers (men or women)
  • Aged from 21 to 65
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • Who have their right leg as their preferred leg
  • Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.
  • Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

Who cannot join

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Person with orthopaedic disorders in the upper or lower limbs
  • Person with neurological disorders
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Caen CHU

    Caen, 14000

    Recruiting

Other trials in France

About this study

Official title: Muscular Force Generation in Microgravity (ForceGeneration)

The aim of this study is to evaluate the applicability of high-load resistance training as a countermeasure for long term space flights, the current project has two scientific goals.

The main objective is to perform a deeper examination of muscle function and MVC in weightlessness (parabolic flight).

The secondary objective is to gather further insight into the underlying mechanisms and structures based on investigations targeting the neuromuscular and musculotendinous systems and their interaction.

Read the detailed description

The findings from water immersion indicated that some motor tasks, such as plantarflexion (25), but not others, such as the leg-press (7), appear to be affected. Thus, it would be relevant to test a number of motor tasks and body regions. On the other hand, parabolic flight requires that methodologies can be performed in a quick efficient fashion. Hence, we propose examining ankle plantarflexion, leg-press and grip-force.

The primary hypothesis is that plantarflexion MVC will be reduced in the microgravity phase of parabolic flight.

As secondary parameters will be assessed parameters of muscle function that can be easily implemented in parabolic flight, such as electromyography and ultrasound measurements of the musculotendinous unit. To assess the muscular system more deeply, for plantarflexion superimposed twitches will be performed (16) during MVC and at rest. An additional experimental condition placing foam (unstable surface; standard size) under the foot during plantarflexion will be included. This approach increases the challenge for the neuromuscular control system and, under such conditions, MVC is reduced (29).

These secondary investigations, which do not prohibitively complicate the practical implementation of the project, will help to understand what is happening in the musculature should we indeed find impediments of muscle force generation in microgravity.

The aim of this study is to evaluate the applicability of high-load resistance training as a countermeasure for long term space flights, the current project has two scientific goals.

The main objective is to perform a deeper examination of muscle function and MVC in weightlessness (parabolic flight).

The secondary objective is to gather further insight into the underlying mechanisms and structures based on investigations targeting the neuromuscular and musculotendinous systems and their interaction.

The main judgment criteria is the MVC tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.

As secondary criteria, we will assess parameters of muscle function that can be easily implemented in parabolic flight:

  • Rate of force development
  • Electromyographic activity
  • Ultrasound measure: fascicle length and pennation angle of the gastrocnemius medialis muscle
  • Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
  • Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%.

The primary hypothesis is that plantarflexion and knee extension force generation capacity will be reduced, but not grip-force, in the microgravity phase of parabolic flight.

Being tested
examination of muscle function and MVC in weightlessness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • examination of muscle function and MVC in weightlessnessOther

    MVC tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.

    parameters of muscle function that can be easily implemented in parabolic flight:

    • Rate of force development
    • Electromyographic activity
    • Ultrasound measure: fascicle length and pennation angle of the gastrocnemius medialis muscle
    • Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
    • Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%.
Study groups in NCT02850328
Study groupRoleWhat they receive
high-load resistance training for long term space flightsOtherShort duration electrical will be delivered and the resulting EMG will be recorded. Intensity of electrical stimulation will be progressively increased until we observed a maximal EMG response. Finally an ultrasound probe (similar to that used for prenatal diagnostic imaging) will be fixed behind your calf in order to visualize muscle.
Receives: Other: examination of muscle function and MVC in weightlessness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum voluntary contraction (MVC)

    tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.

    Measured: baseline

Secondary outcomes (6)
  1. parameters of muscle function, Rate of force development

    Measured: baseline

  2. parameters of muscle function, Electromyographic activity

    Measured: baseline

  3. parameters of muscle function, Ultrasound measure: fascicle length

    Measured: baseline

  4. parameters of muscle function, Ultrasound measure: pennation angle of the gastrocnemius medialis muscle

    Measured: baseline

  5. parameters of muscle function, Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)

    Measured: baseline

  6. parameters of muscle function, Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02850328
Sponsor's protocol ID
2014-A00814-43
Acronym
ForceGeneratio
Status last verified
Jul 2016
First submitted
21 Apr 2016
Last updated
18 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing examination of muscle function and MVC in weightlessness in people with Maximum Voluntary Contraction, run by University Hospital, Caen 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 8 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: status not confirmed, as of the sponsor's last update on 18 Aug 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pierre DP Denise, PhD (02.31.06.81.32 ext. +33, pierre.denise@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum voluntary contraction (MVC) (time frame: baseline). 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 18 Aug 2017.

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