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.
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.
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.
- Conditions
- Maximum Voluntary Contraction
- 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 group | Role | What they receive |
|---|---|---|
| high-load resistance training for long term space flights | Other | Short 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.
maximum voluntary contraction (MVC)
tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.
Measured: baseline
Secondary outcomes (6)
parameters of muscle function, Rate of force development
Measured: baseline
parameters of muscle function, Electromyographic activity
Measured: baseline
parameters of muscle function, Ultrasound measure: fascicle length
Measured: baseline
parameters of muscle function, Ultrasound measure: pennation angle of the gastrocnemius medialis muscle
Measured: baseline
parameters of muscle function, Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
Measured: baseline
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.
- First posted1 Aug 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maximum Voluntary ContractionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Novespace
- Responsible party
- Sponsor
- Investigators
- Pierre DP Denise, PhD, Principal investigator, UMR 1075 UFR de Médecine Caen
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Force Generation in Microgravity (ForceGeneration)
- ClinicalTrials.gov ID
- NCT02850328
- Acronym / sponsor ID
- ForceGeneratio / 2014-A00814-43
- Conditions
- Maximum Voluntary Contraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Novespace
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Aug 2016 (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 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-load resistance training for long term space flights | Other | Other: examination of muscle function and MVC in weightlessnessShort 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| examination of muscle function and MVC in weightlessnessMVC 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%. | Other | high-load resistance training for long term space flights |
Primary outcome
maximum voluntary contraction (MVC)
Time frame: baseline
tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.
6 secondary outcomes
parameters of muscle function, Rate of force development
Time frame: baseline
parameters of muscle function, Electromyographic activity
Time frame: baseline
parameters of muscle function, Ultrasound measure: fascicle length
Time frame: baseline
parameters of muscle function, Ultrasound measure: pennation angle of the gastrocnemius medialis muscle
Time frame: baseline
parameters of muscle function, Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
Time frame: baseline
parameters of muscle function, Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Maximum Voluntary Contraction
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Recruiting
Effects of Inter-Set Rest Intervals on Muscle Damage After Flywheel Exercise in Untrained Men (RCT)
Exercise-induced Muscle Damage
Enrolling by invitation
Acute Effects of Bilateral Versus Unilateral Isometric Conditioning Activity on Jump Performance in Volleyball Players
Athletic Performance, Volleyball
Recruiting
Influence of Tea Extract on Maximal Voluntary Knee Contraction Following Downhill Jogging
Muscle Recovery
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.
Pierre DP Denise, PhD principal investigator
UMR 1075 UFR de Médecine Caen
1 site in 1 country: see every site and its status.
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.