- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850328
Muscular Force Generation in Microgravity (ForceGeneratio)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- Caen CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: high-load resistance training for long term space flights
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. |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximum voluntary contraction (MVC)
Time Frame: baseline
|
tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
parameters of muscle function, Rate of force development
Time Frame: baseline
|
baseline
|
|
parameters of muscle function, Electromyographic activity
Time Frame: baseline
|
baseline
|
|
parameters of muscle function, Ultrasound measure: fascicle length
Time Frame: baseline
|
baseline
|
|
parameters of muscle function, Ultrasound measure: pennation angle of the gastrocnemius medialis muscle
Time Frame: baseline
|
baseline
|
|
parameters of muscle function, Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
Time Frame: baseline
|
baseline
|
|
parameters of muscle function, Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%.
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pierre DP Denise, PhD, UMR 1075 UFR de Médecine Caen
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-A00814-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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