healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: •Healthy male participants aged between 20 and 45 years old with a Body Mass Index (BMI) of 19-25 kg/m2 and a height of 170-210 cm •Body weight = 120kg •Non-smoker for at least five years prior to the start of the study, including e-cigarettes •Successful completion of screening examination •Ability to comprehend and consent to the risks associated with the study to provide in-formed consent •In the position to participate in the complete study.
Exclusion criteria
Exclusion criteria: •Drug or alcohol abuse (regular consumption of > 20 g alcohol / day) •Alcohol: ingestion within 12 hours of start of study •Caffeine: ingestion within 8 hours of start of study •Current muscle or joint disease •Known artifacts in the lumbar or cervical spine regions or spinal abnormalities that could affect imaging •Herniated disc. •Chronic back pain •Allergies to ultrasound gel, medical tape or its ingredients •Deafness •Diabetes mellitus. •Heart disease or a cardiac pacemaker. •Abnormal blood pressure (above 140/90 mmHg or below 90/60 mmHg) •Severe orthostatic intolerance or impaired neurovestibular function •Kidney disease (deviations from normal values of creatinine in plasma; Creatinine normal value < 1.20 mg/dL) •Thyroid dysfunction (deviations from normal values for TSH in plasma; normal values TSH 0,27 – 4,20 mU/l) (a laboratory examination carried out only in case of suspicion of dys-function) •Anemia (Hb lower than normal value; standard value Hb men: from 13.5 to 17.5 g/dL; women: from 12.0 to 15.7 g/dL) •History of epileptic seizures •Use of psychotropic drugs and any other drugs that may affect the study experiments. •Any treatment with drug contains prednisone •Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the project lead
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Team #1: •Changes in hemodynamic parameters and arterial baroreflex •Changes in muscle pump activation between: supine and stand, supine and 1g/1.5g •Change in muscle pump activation after exercise During each stand test, successful completion is reaching 5 minutes of quiet standing without losing balance or having adverse cardiovascular responses. The completion of the 4th stand test (after standing squats) is the end of this study protocol. Team #2: •Changes in anterior lumbar and cervical disc height measured with ultrasound Team #3: •Stress during spin could be reduced by Music. •Pleasantness questionnaire determine which musical samples have positive response and if it was during the spin and/or after the spin. •Muscle tone changes could be reduced by Music. •Correlations between sociocultural variables (age, gender, preferred musical genres, music education etc.) and the results (attitudes, changes in POMS etc.). | — |
Secondary
| Measure | Time frame |
|---|---|
| Team #1: •To assess the muscle pump baroreflex in relation to cardiovascular control and postural stability we collect four physiological signals: i) an electrocardiogram (ECG), ii) beat-to-beat blood pressure, iii) calf skeletal muscle activity through electromyography (EMG), and iv) postural sway. For this proposal we will also add a fifth component: an electro-oculogram (EOG) to measure eye movements since the vestibular system is altered with exposure to weightlessness. •Calf vasoconstriction and venous pooling will be monitored with near infra-red spectroscopy (NIRS). A wavelet coherence analysis will be utilized to determine commonality in fluctuations of systolic blood pressure and lower leg muscle activity. The analysis is split between 3 frequency bands (high, low, very low), each of which are known to represent different characteristics of various cardiovascular control modes. All measurements are made over the entire centrifugation and training period. Team #2: •Ultrasound of IVDs (cervical and lumbal) The ultrasound measurements take place immediately before centrifugation and after both centrifugations. Team #3: •questionnaires: -Astronaut Musical Roots Questionnaire (sociocultural variables) -Music-related and Music Therapy-related Attitudes Questionnaire -POMS -Discomfort-/Pain-Questionnaire -Music Pleasantness Questionnaire The questionnaires are filled out by the subjects before the centrifugation. The MSAQ Questionaire is filled out immediately after each centrifugation. The POMS questionnaire also after the last training session on the force plate. •4 Saliva samples (Cortisol, Cortison): -2 days before centrifuge run -Pre/post centrifugation -5 hours after centrifugation •Myoton measurements for assessment of muscle tone Similar to the ultrasound measurements, the Mytoton measurements take place immediately before the first centrifugation and after both centrifugations.. •Galvanic skin conductance | — |
Countries
Germany
Contacts
DLR - Institut für Luft- und Raumfahrtmedizin