Biological and Functional Markers for Precision Astronautical Biomedicine
NCT04081467, Not applicable, Completed, Science and Research Centre Koper
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Biological and Functional Markers for Precision Astronautical Biomedicine | ClinicalTrials.gov |
| NCT number | NCT04081467 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 10 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Science and Research Centre Koper | ClinicalTrials.gov |
| Conditions | Muscular Atrophy | ClinicalTrials.gov |
| Interventions | Bed rest | ClinicalTrials.gov |
| First posted | 2019-09-09 | ClinicalTrials.gov |
| Last updated | 2020-05-01 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in mittochondria respiration rate | At baseline and after 10-day bed rest | Change in Mittochondria oxygen respiration rate per mg of muscle tissue after 10-day bed rest | ClinicalTrials.gov |
| Primary | Change in skeletal muscle single fibre force (in micro Newtons) | 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. | ClinicalTrials.gov |
| Primary | Change in Neurological outcomes - nerve conduction velocity | At baseline and after 10-day bed rest | Change in nerve conduction velocity after 10-day bed rest | ClinicalTrials.gov |
| Primary | Change in Neurological outcomes - fMRI | 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 | ClinicalTrials.gov |
| Primary | Change in Neurological outcomes - neurocognitive assessment | 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 | ClinicalTrials.gov |
| Primary | Change in skeletal muscle NCAM expression in single fibres | 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. | ClinicalTrials.gov |
| Secondary | Change in muscle volume after 10-day bed rest | 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. | ClinicalTrials.gov |
| Secondary | Change in peak aerobic power after 10-day bed rest | 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. | ClinicalTrials.gov |
| Secondary | 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 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. | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | Change in skeletal composition after 10-day bed rest | 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 | ClinicalTrials.gov |
| Secondary | Change in skeletal muscle maximal voluntary contraction after 10-day bed rest | At baseline and after 10-day bed rest | Maximal voluntary isometric knee extensors contraction will be measured using dnamometer set at 90 deg flexion. | ClinicalTrials.gov |
| Secondary | Change in balance after 10-day bed rest | 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 | ClinicalTrials.gov |
| Secondary | Change in orthostatic tolerance after 10-day bed rest | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 9
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)