Clinical trial NCT02850328: Muscular Force Generation in Microgravity
Official title: Muscular Force Generation in Microgravity (ForceGeneration)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maximum Voluntary Contraction
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Novespace
First posted: 2016-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: maximum voluntary contraction (MVC)
timeFrame: baseline
Secondary outcomes:
measure: parameters of muscle function, Rate of force development
timeFrame: baseline
measure: parameters of muscle function, Electromyographic activity
timeFrame: baseline
measure: parameters of muscle function, Ultrasound measure: fascicle length
timeFrame: baseline
measure: parameters of muscle function, Ultrasound measure: pennation angle of the gastrocnemius medialis muscle
timeFrame: baseline
measure: parameters of muscle function, Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
timeFrame: baseline
measure: parameters of muscle function, Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%.
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen CHU
Study officials:
affiliation: UMR 1075 UFR de Médecine Caen
name: Pierre DP Denise, PhD
role: PRINCIPAL_INVESTIGATOR
References: