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Completed

NCT Number: NCT04081467

Biological and Functional Markers for Precision Astronautical Biomedicine

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Splosna bolnisnica Izola (Hospital of Izola)

Izola, 6310, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bed Rest

Other

10-day of complete bed rest

Other names: immobilization, bed rest confinement, prolonged physical inactivity

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

Science and Research Centre Koper

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MARS-PRE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2019
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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