Muscular AtrophyMARS-PRENCT04081467
Biological and Functional Markers for Precision Astronautical Biomedicine
A study testing Bed rest in people with Muscular Atrophy, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- Bed rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 28 Aug 2019to 16 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscular Atrophy
- Being tested
- Bed rest
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restOther
Also called immobilization, bed rest confinement, prolonged physical inactivity
10-day of complete bed rest
| Study group | Role | What they receive |
|---|---|---|
| bed rest condition | Experimental | Bed rest condition without any additional intervention Receives: Other: Bed rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mittochondria respiration rate
Change in Mittochondria oxygen respiration rate per mg of muscle tissue after 10-day bed rest
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Before, at day 5 and day 10 of bed rest
Secondary outcomes (8)
Change in muscle volume 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.
Measured: At baseline and after 10-day bed rest
Change in peak aerobic power after 10-day bed rest
Change in peak aerobic power (maximal oxygen consumption) will be assessed on a cycloergometer using graded load protocol.
Measured: At baseline and after 10-day bed rest
Nonhomogeneous change in skeletal muscle pennation angle 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.
Measured: 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
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.
Measured: At baseline, every 2 days of bed rest and after 10-day bed rest
Change in skeletal composition 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
Measured: At baseline, day 5 and after 10-day bed rest
Change in skeletal muscle maximal voluntary contraction after 10-day bed rest
Maximal voluntary isometric knee extensors contraction will be measured using dnamometer set at 90 deg flexion.
Measured: At baseline and after 10-day bed rest
Change in balance 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
Measured: At baseline and after 10-day bed rest
Change in orthostatic tolerance 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.
Measured: At baseline and after 10-day bed rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start28 Aug 2019
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of 10 will undergo 10 days of horizontal bed rest without countermeasures.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, University of Bari, University of Genova, University of L'Aquila, University of Pavia, University of Trieste, Humanitas Hospital, Italy, University of Rome
- Responsible party
- Principal investigator, Rado Pisot, Science and Research Centre Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081467
- Sponsor's protocol ID
- BR2019 MARS-PRE
- Acronym
- MARS-PRE
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2019
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is shared among partners for various publications
Publications
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.
PubMed 26823343Simunic 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.
PubMed 30676871Floreani 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.
PubMed 29529070Rejc 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.
PubMed 29266264Passaro 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.
PubMed 28161695Marusic 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.
PubMed 27937138Marusic 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.
PubMed 25938245Marusic 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.
PubMed 24734884Rejc 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.
PubMed 25613402
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARS-PRE: MARcatori Biologici e Funzionali Per la Biomedicina aStronautica di PREcisione
- ClinicalTrials.gov ID
- NCT04081467
- Acronym / sponsor ID
- MARS-PRE / BR2019 MARS-PRE
- Conditions
- Muscular Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- University of Padova, University of Bari, University of Genova, University of L'Aquila, University of Pavia, University of Trieste, Humanitas Hospital, Italy, University of Rome
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of 10 will undergo 10 days of horizontal bed rest without countermeasures.
| Arm | Type | Receives |
|---|---|---|
| bed rest condition | Experimental | Other: Bed restBed rest condition without any additional intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed restAlso: immobilization, bed rest confinement, prolonged physical inactivity10-day of complete bed rest | Other | bed rest condition |
Primary outcome
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
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.
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
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
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
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.
8 secondary outcomes
Change in muscle volume after 10-day bed rest
Time frame: 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
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 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
Change in skeletal composition after 10-day bed rest
Time frame: 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
Change in balance after 10-day bed rest
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Background: PubMed 26823343Pisot 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.
- Background: PubMed 30676871Simunic 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.
- Background: PubMed 29529070Floreani 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.
- Background: PubMed 29266264Rejc 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.
- Background: PubMed 28161695Passaro 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.
- Background: PubMed 27937138Marusic 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.
- Background: PubMed 25938245Marusic 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.
- Background: PubMed 24734884Marusic 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.
- Background: PubMed 25613402Rejc 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.
- Individual participant dataSharing planned: No. The data is shared among partners for various publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest in people with Muscular Atrophy, run by Science and Research Centre Koper at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mittochondria respiration rate (time frame: At baseline and after 10-day bed rest). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081467, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.