Muscular Force Generation in Microgravity
ForceGeneratio
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 18, 2017
July 1, 2016
3 years
April 21, 2016
August 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
maximum voluntary contraction (MVC)
tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.
baseline
Secondary Outcomes (6)
parameters of muscle function, Rate of force development
baseline
parameters of muscle function, Electromyographic activity
baseline
parameters of muscle function, Ultrasound measure: fascicle length
baseline
parameters of muscle function, Ultrasound measure: pennation angle of the gastrocnemius medialis muscle
baseline
parameters of muscle function, Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
baseline
- +1 more secondary outcomes
Study Arms (1)
high-load resistance training for long term space flights
OTHERShort 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.
Interventions
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%.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Person with orthopaedic disorders in the upper or lower limbs
- Person with neurological disorders
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- Novespacecollaborator
Study Sites (1)
Caen CHU
Caen, 14000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre DP Denise, PhD
UMR 1075 UFR de Médecine Caen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2016
First Posted
August 1, 2016
Study Start
September 1, 2014
Primary Completion
September 1, 2017
Study Completion
October 1, 2017
Last Updated
August 18, 2017
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share