Healthy subjects
Conditions
Interventions
Group 1: 30 min constant load cycling at LTP1 (low intensity)
Group 2: 30 min constant load cycling between LTP1 and LTP2 (moderate intensity)
Group 3: 30 min constant load cycling at LTP2 (high inten
Sponsors
Universitaet Bayreuth
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: - Men or women aged 18 to 35 (both age groups inclusive) - Body mass index (BMI) between 18.5 and 29.9 kg·m?² (both inclusive) - Read the patient information sheet and signed the informed consent
Exclusion criteria
Exclusion criteria: - Simultaneous enrolment in any other study - Known or suspected hypersensitivity to trial products or related products - Smoking within the past six months - Exposure to high altitude within the past three months (lasting longer than two weeks at >1800 m for more than 20 hours per day) - Blood donation within the last three months - Plasma donation within the last seven days - Receipt of any investigational medicinal product within one week prior to screening in this trial - Suffering from, or having a history of a life-threatening disease (e.g., cancer not in full remission except for basal cell or squamous cell skin cancer) - Clinically severe diseases that could directly influence the study results, as judged by the investigator - Blood pressure outside the range of 90–150 mmHg systolic or 50–95 mmHg diastolic after 5 minutes of rest in the supine position - Clinically significant abnormal ECG at screening as judged by the medical investigator - Any chronic metabolic disorder or severe disease that might jeopardize safety or compliance - Females of childbearing potential who were pregnant or intending to become pregnant (pregnancy confirmed by a positive test) - Musculoskeletal conditions limiting cycling ability - Mental incapacity or language barriers impairing understanding or cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Mean SV in mL during 30-minute constant load cycling exercise at the LTP1 measured by cardioimpedance analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| -Mean SV in mL during 30-minute constant load cycling exercise between the LTP1 and LTP2 measured by cardioimpedance analysis -Mean SV in mL during 30-minute constant load cycling exercise at the LTP2 measured by cardioimpedance analysis - Q?mean_CONI-III: Mean Q? in mL/min during constant load cycling exercise (CON) in comparison between trial arms. - HRmean_CONI-III: Mean HR in beats/minute during constant load cycling exercise (CON) in comparison between trial arms. - V?O2mean_CONI-III: Mean V?O2 in mL/min/kg during constant load cycling exercise (CON) in comparison between trial arms. - ?PVCONI-III: Maximum change in PV in mL during constant load cycling exercise (CON) in comparison between trial arms. - ?[Hb]CONI-III: Maximum change in [Hb] in mg/dl during constant load cycling exercise (CON) in comparison between trial arms. - ?HctCONI-III: Maximum change in Hct in % during constant load cycling exercise (CON) in comparison between trial arms. - ?ScO2_CONI-III: Maximum change in ScO2 in % during constant load cycling exercise (CON) in comparison between trial arms. - CaO2mean_CONI-III: Mean CaO2 in mL/dL during constant load cycling exercise (CON) in comparison between trial arms. - R_SVmax_BVrest: Correlation coefficient between maximum SV in mL and resting BV in mL. - R_SVmax_V?O2max: Correlation coefficient between maximum SV in mL and maximum V?O2 in in mL/min/kg. - R_Q?max_BVrest: Correlation coefficient between maximum Q? in mL/min and resting BV in mL. - R_V?O2max_BVrest: Correlation coefficient between maximum SV in mL and resting BV in mL. - R_SVmax_Cardiac Structuresrest: Correlation coefficient between maximum SV in mL and resting cardiac structures, i.e., LA endsys (cm2), RA endsys (cm2), TAPSE (mm), SVI, LVMM (g), LVMM (g/kg), LVMM (g/m2), RWT, LVPWD (mm), IVSD (mm), SV (mL), SV (mL/kg), SV (mL/m2), EDV (mL), ESV (mL), LVEDD (mm) and LV endsys (mm). - R_Q?max_Cardiac Structuresrest: Correlation coefficient between maximum Q? in mL/m | — |
Countries
Germany
Contacts
Public ContactJanis Schierbauer
Universitaet Bayreuth
Outcome results
None listed