Clinical trial NCT04081467: Biological and Functional Markers for Precision Astronautical Biomedicine
Official title: MARS-PRE: MARcatori Biologici e Funzionali Per la Biomedicina aStronautica di PREcisione
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Atrophy
Lead sponsor: Science and Research Centre Koper
Sponsor class: OTHER
Collaborators: name: University of Padova
name: University of Bari
name: University of Genova
name: University of L'Aquila
name: University of Pavia
name: University of Trieste
name: Humanitas Hospital, Italy
name: University of Rome
First posted: 2019-09-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of 10 will undergo 10 days of horizontal bed rest without countermeasures.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in mittochondria respiration rate
timeFrame: At baseline and after 10-day bed rest
measure: Change in skeletal muscle single fibre force (in micro Newtons)
timeFrame: At baseline and after 10-day bed rest
measure: Change in Neurological outcomes - nerve conduction velocity
timeFrame: At baseline and after 10-day bed rest
measure: Change in Neurological outcomes - fMRI
timeFrame: At baseline and after 10-day bed rest
measure: Change in Neurological outcomes - neurocognitive assessment
timeFrame: At baseline and after 10-day bed rest
measure: Change in skeletal muscle NCAM expression in single fibres
timeFrame: Before, at day 5 and day 10 of bed rest
Secondary outcomes:
measure: Change in muscle volume after 10-day bed rest
timeFrame: At baseline and after 10-day bed rest
measure: Change in peak aerobic power after 10-day bed rest
timeFrame: At baseline and after 10-day bed rest
measure: Nonhomogeneous change in skeletal muscle pennation angle after 10-day bed rest
timeFrame: At baseline, every 2 days of bed rest and after 10-day bed rest
measure: Change in maximal displacement after twitch contraction after 10-day bed rest
timeFrame: At baseline, every 2 days of bed rest and after 10-day bed rest
measure: Change in skeletal composition after 10-day bed rest
timeFrame: At baseline, day 5 and after 10-day bed rest
measure: Change in skeletal muscle maximal voluntary contraction after 10-day bed rest
timeFrame: At baseline and after 10-day bed rest
measure: Change in balance after 10-day bed rest
timeFrame: At baseline and after 10-day bed rest
measure: Change in orthostatic tolerance after 10-day bed rest
timeFrame: At baseline and after 10-day bed rest
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: Splosna bolnisnica Izola (Hospital of Izola)
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.