Biological and Functional Markers for Precision Astronautical Biomedicine

NCT04081467 | Completed

• 1 other identifier: BR2019 MARS-PRE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscular Atrophy

Outcome Measures

Primary Outcomes (6)

• Change in mittochondria respiration rate

  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)

  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

  Change in nerve conduction velocity after 10-day bed rest

  At baseline and after 10-day bed rest

• Change in Neurological outcomes - fMRI

  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

  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

  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 Outcomes (8)

• Change in muscle volume after 10-day bed rest

  At baseline and after 10-day bed rest

• Change in peak aerobic power after 10-day bed rest

  At baseline and after 10-day bed rest

• Nonhomogeneous change in skeletal muscle pennation angle after 10-day 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

  At baseline, every 2 days of bed rest and after 10-day bed rest

• Change in skeletal composition after 10-day bed rest

  At baseline, day 5 and after 10-day bed rest

Study Arms (1)

bed rest condition

EXPERIMENTAL

Bed rest condition without any additional intervention

Other: Bed rest

Interventions

Bed rest OTHER

10-day of complete bed rest

Also known as: immobilization, bed rest confinement, prolonged physical inactivity

bed rest condition

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Science and Research Centre Koper: lead
• University of Padova: collaborator
• University of Bari: collaborator
• University of Genova: collaborator
• University of L'Aquila: collaborator
• University of Pavia: collaborator
• University of Trieste: collaborator
• Humanitas Hospital, Italy: collaborator
• University of Rome: collaborator

Study Sites (1)

Splosna bolnisnica Izola (Hospital of Izola)

Izola, 6310, Slovenia

Location

Related Publications (9)

• Pisot R, Marusic U, Biolo G, Mazzucco S, Lazzer S, Grassi B, Reggiani C, Toniolo L, di Prampero PE, Passaro A, Narici M, Mohammed S, Rittweger J, Gasparini M, Gabrijelcic Blenkus M, Simunic B. Greater loss in muscle mass and function but smaller metabolic alterations in older compared with younger men following 2 wk of bed rest and recovery. J Appl Physiol (1985). 2016 Apr 15;120(8):922-9. doi: 10.1152/japplphysiol.00858.2015. Epub 2016 Jan 28.

  PMID: 26823343 BACKGROUND

• Simunic B, Koren K, Rittweger J, Lazzer S, Reggiani C, Rejc E, Pisot R, Narici M, Degens H. Tensiomyography detects early hallmarks of bed-rest-induced atrophy before changes in muscle architecture. J Appl Physiol (1985). 2019 Apr 1;126(4):815-822. doi: 10.1152/japplphysiol.00880.2018. Epub 2019 Jan 24.

  PMID: 30676871 BACKGROUND

• Floreani M, Rejc E, Taboga P, Ganzini A, Pisot R, Simunic B, Biolo G, Reggiani C, Passaro A, Narici M, Rittweger J, di Prampero PE, Lazzer S. Effects of 14 days of bed rest and following physical training on metabolic cost, mechanical work, and efficiency during walking in older and young healthy males. PLoS One. 2018 Mar 12;13(3):e0194291. doi: 10.1371/journal.pone.0194291. eCollection 2018.

  PMID: 29529070 BACKGROUND

• Rejc E, Floreani M, Taboga P, Botter A, Toniolo L, Cancellara L, Narici M, Simunic B, Pisot R, Biolo G, Passaro A, Rittweger J, Reggiani C, Lazzer S. Loss of maximal explosive power of lower limbs after 2 weeks of disuse and incomplete recovery after retraining in older adults. J Physiol. 2018 Feb 15;596(4):647-665. doi: 10.1113/JP274772. Epub 2018 Jan 19.

  PMID: 29266264 BACKGROUND

• Passaro A, Soavi C, Marusic U, Rejc E, Sanz JM, Morieri ML, Nora ED, Kavcic V, Narici MV, Reggiani C, Biolo G, Zuliani G, Lazzer S, Pisot R. Computerized cognitive training and brain derived neurotrophic factor during bed rest: mechanisms to protect individual during acute stress. Aging (Albany NY). 2017 Feb 3;9(2):393-407. doi: 10.18632/aging.101166.

  PMID: 28161695 BACKGROUND

• Marusic U, Giordani B, Moffat SD, Petric M, Dolenc P, Pisot R, Kavcic V. Computerized cognitive training during physical inactivity improves executive functioning in older adults. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2018 Jan;25(1):49-69. doi: 10.1080/13825585.2016.1263724. Epub 2016 Dec 12.

  PMID: 27937138 BACKGROUND

• Marusic U, Kavcic V, Giordani B, Gerzevic M, Meeusen R, Pisot R. Computerized spatial navigation training during 14 days of bed rest in healthy older adult men: Effect on gait performance. Psychol Aging. 2015 Jun;30(2):334-340. doi: 10.1037/pag0000021. Epub 2015 May 4.

  PMID: 25938245 BACKGROUND

• Marusic U, Meeusen R, Pisot R, Kavcic V. The brain in micro- and hypergravity: the effects of changing gravity on the brain electrocortical activity. Eur J Sport Sci. 2014;14(8):813-22. doi: 10.1080/17461391.2014.908959. Epub 2014 Apr 15.

  PMID: 24734884 BACKGROUND

• Rejc E, di Prampero PE, Lazzer S, Grassi B, Simunic B, Pisot R, Antonutto G, Narici M. A 35-day bed rest does not alter the bilateral deficit of the lower limbs during explosive efforts. Eur J Appl Physiol. 2015 Jun;115(6):1323-30. doi: 10.1007/s00421-015-3111-2. Epub 2015 Jan 23.

  PMID: 25613402 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Bed Rest; Immobilization

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. Rado Pisot, PhD, prof. Marco Narici, MD, PhD, prof. Bostjan Simunic, PhD, Assistant professor Uros Marusic, PhD,

Model Details: One group of 10 will undergo 10 days of horizontal bed rest without countermeasures.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: September 9, 2019
• Study Start: August 28, 2019
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)