Biological and Functional Markers for Precision Astronautical Biomedicine (MARS-PRE)

April 29, 2020 updated by: Rado Pisot, Science and Research Centre Koper

MARS-PRE: MARcatori Biologici e Funzionali Per la Biomedicina aStronautica di PREcisione

In the current study the investigators will study early biomarkers of human degradation. In 10-day horizontal bed rest the investigators will enroll 10 healthy male subjects (18-30years, BMI 20-28kg/m2). Pre-, mid- and post-bed rest the investigators will perform various measurements, some of them will be invasive (blood samples and muscle biopsies), which will be carefully taken by the medical staff. The subjects will be placed in hospital rooms and have 24-hour medical supervision, adequate hygiene, nutrition, passive exercise, entertainment and visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ten young male participants will undergo 10 days of horizontal bed rest. Before, during and after the investigators will monitor many biomechanical, metabolic, cardiovascular, biochemical responses.

During the bed rest period there will be no interventions. subjects will be allowed to rotate freely, with no vertical stimulus of any-kind.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • 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 Locations

  • Slovenia
      • Izola, Slovenia, 6310
        • Splosna bolnisnica Izola (Hospital of Izola)

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

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body mass index between 20 - 28 kg/m2
  • male participants
  • a healthy individual who is able to complete all the tests planned in the research protocol

Exclusion Criteria:

  • smoking;
  • regular alcohol consumption;
  • ferromagnetic implants;
  • history of deep vein thrombosis with D-dimer > 500 μg·L-1;
  • acute or chronic skeletal, neuromuscular, psychological, metabolic and cardiovascular disease conditions.

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: bed rest condition
Bed rest condition without any additional intervention
Other: Bed rest
10-day of complete bed rest
Other Names:
  • immobilization
  • bed rest confinement
  • prolonged physical inactivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mittochondria respiration rate
Time Frame: At baseline and after 10-day bed rest
Change in Mittochondria oxygen respiration rate per mg of muscle tissue after 10-day bed rest
At baseline and after 10-day bed rest
Change in skeletal muscle single fibre force (in micro Newtons)
Time Frame: At baseline and after 10-day bed rest
In each aprticipants at each time point approx 10 intact muscle fibres will be studied for their force production after 10-day bed rest. Isometric muscle fibre force (in mNewton) will be measured isometric force (Fo) in four subsequent maximal activations (pCa, 4.6; sarcomere length, 2.6 micrometers; temperature 12 degrees C) using an electrical motor with force transducer mounted on it.
At baseline and after 10-day bed rest
Change in Neurological outcomes - nerve conduction velocity
Time Frame: At baseline and after 10-day bed rest
Change in nerve conduction velocity after 10-day bed rest
At baseline and after 10-day bed rest
Change in Neurological outcomes - fMRI
Time Frame: At baseline and after 10-day bed rest
Change in ability to mentally imagine/perform locomotory tasks (voxel-based network analyses) after 10-day bed rest
At baseline and after 10-day bed rest
Change in Neurological outcomes - neurocognitive assessment
Time Frame: At baseline and after 10-day bed rest
Change in EEG and neurocognitive tasks parameters (event related potential; P300 component during Stroop task) after 10-day bed rest
At baseline and after 10-day bed rest
Change in skeletal muscle NCAM expression in single fibres
Time Frame: Before, at day 5 and day 10 of bed rest
Neural cell adhesion molecule (NCAM) expression will be analysed in vastus lateralis biopsy samples at three time points.
Before, at day 5 and day 10 of bed rest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle volume after 10-day bed rest
Time Frame: At baseline and after 10-day bed rest
Thigh muscle volume will be assessed by continous section obtained by 3T MRI. Muscle segmentation will done by Matlab routine.
At baseline and after 10-day bed rest
Change in peak aerobic power after 10-day bed rest
Time Frame: At baseline and after 10-day bed rest
Change in peak aerobic power (maximal oxygen consumption) will be assessed on a cycloergometer using graded load protocol.
At baseline and after 10-day bed rest
Nonhomogeneous change in skeletal muscle pennation angle after 10-day bed rest
Time Frame: At baseline, every 2 days of bed rest and after 10-day bed rest
Change in Muscle architecture will be assessed in vastus lateralis, biceps femoris, tibialis anterior, multifidus using sonography. Specifically, we will assess all three architecture parameters (pennation angle, fascicle length and thickness), however for the purspose of this outcome we hypothesize non-homogenous change throughout the whole muscles in pennation angle. The assessment will be performed before, every 2 days of bed rest and post bed rest.
At baseline, every 2 days of bed rest and after 10-day bed rest
Change in maximal displacement after twitch contraction after 10-day bed rest
Time Frame: At baseline, every 2 days of bed rest and after 10-day bed rest
Using tensiomyography we will assess contraction time and maximal discplacement in vastus lateralis, tibialis anterior, biceps femoris, multifidus muscles. We expect that contraction time will remained the same but maximal diasplacement - a measure of a muscle tone, will increase much before the changes in muscle thickness - assessed by sonography. The assessment will be performed before, every 2 days of bed rest and post bed rest.
At baseline, every 2 days of bed rest and after 10-day bed rest
Change in skeletal composition after 10-day bed rest
Time Frame: At baseline, day 5 and after 10-day bed rest
Using electrophoresis we will assess changes in myosing heavy chains somposition in the biopsies obtained from vastus lateralis muscle before, at day 5 and post 10 days of bed rest
At baseline, day 5 and after 10-day bed rest
Change in skeletal muscle maximal voluntary contraction after 10-day bed rest
Time Frame: At baseline and after 10-day bed rest
Maximal voluntary isometric knee extensors contraction will be measured using dnamometer set at 90 deg flexion.
At baseline and after 10-day bed rest
Change in balance after 10-day bed rest
Time Frame: At baseline and after 10-day bed rest
Change in static and dynamic balance will be assessed by functional tests (gait assessed with Optogait system and balance assessed with Tensiometric plate-COP) after 10-day bed rest
At baseline and after 10-day bed rest
Change in orthostatic tolerance after 10-day bed rest
Time Frame: At baseline and after 10-day bed rest
Change in mean arterial pressure during supine-to-stand test (mmHg) will be assessed by supine to stand test, where subjects will stay 10 minutes in each position.
At baseline and after 10-day bed rest

Collaborators and Investigators

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

Sponsor

Science and Research Centre Koper

Collaborators

University of Trieste
University of Padova
University of Pavia
University of L'Aquila
University of Genova
University of Bari
Humanitas Hospital, Italy
University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

August 28, 2019

Primary Completion (ACTUAL)

October 16, 2019

Study Completion (ACTUAL)

October 16, 2019

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (ACTUAL)

September 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR2019 MARS-PRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is shared among partners for various publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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