NCT02850328

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

April 21, 2016

Last Update Submit

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

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.

Other: examination of muscle function and MVC in weightlessness

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%.

high-load resistance training for long term space flights

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Caen CHU

Caen, 14000, France

RECRUITING

MeSH Terms

Interventions

Weightlessness

Intervention Hierarchy (Ancestors)

HypogravityGravity, AlteredGravitationAstronomical PhenomenaPhysical Phenomena

Study Officials

  • Pierre DP Denise, PhD

    UMR 1075 UFR de Médecine Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre DP Denise, PhD

CONTACT

Cathy GC Gaillard

CONTACT

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

Locations