Muscular Force Generation in Microgravity (ForceGeneratio)

August 16, 2017 updated by: University Hospital, Caen

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • Caen CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: examination of muscle function and MVC in weightlessness

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%.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Caen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novespace

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre DP Denise, PhD, UMR 1075 UFR de Médecine Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-A00814-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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