An interventional study of Standardized Bicycle Ergometer Exercise in Effects of Standardized Physical Exercise on a Bicycle Ergometer on the Perfusion Index (PI) and Other Cardiovascular Parameters, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Not applicable, Interventional, and Basic science
This study examines how cycling on an exercise bicycle affects blood flow and heart and circulation in 12 healthy adult men. The main measurement is the perfusion index, which indicates how well blood is flowing through the small blood vessels. The study also measures pulse waves, blood pressure, the time it takes for the pulse wave to travel through the body, changes in heart rate, and the relationship between pulse and breathing. In addition, two pulse oximeter systems, Masimo and Nellcor, are compared, as well as measurements taken from the forehead and the finger.
This single-center clinical study investigates the effects of standardized physical exercise on a bicycle ergometer on the perfusion index (PI) and other cardiovascular parameters. In 12 healthy adult male participants (age 20 - 40 years) cardiovascular parameters before, during and after a single standardized bicycle ergometer exercise test (half-lying position) are recorded with different devices (GeTeMed Vitaguard 3100; Masimo Radical-7; Nellcor N-600; Micro Medical PulseTrace PWV; Schiller MT300 Light-Holter-BPR; TOM Medical Single-lead ECG) and compared. In addition, two pulse oximeters will be compared (Masimo versus Nellcor), as well as the measurement quality of forehead and finger sensors. After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 28 minutes, followed by a 16-minute rest period. It is hypothesized that the PI will increase during exercise and subsequently decrease during the recovery phase.
ARCIM Institute Academic Research in Complementary and Integrative Medicine is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy male participants aged 20 to 40 years undergo a single standardized bicycle ergometer exercise test in a semi-recumbent position. Following a 12-minute pre-exercise resting period, participants perform 28 minutes of graded bicycle ergometer exercise at exercise intensities ranging from 30% to 90% of their individual maximum exercise capacity. The exercise period is followed by a 16-minute post-exercise recovery period. Cardiovascular, hemodynamic, heart rate variability, photoplethysmographic, and pulse oximetry parameters are recorded before, during, and after exercise using multiple measurement devices.
Behavioral: Standardized Bicycle Ergometer Exercise
Participants undergo a single standardized bicycle ergometer exercise test in a semi-recumbent position. After a 12-minute resting period, participants exercise for 28 minutes at graded intensities ranging from 30% to 90% of their individual maximum exercise capacity. Exercise intensity is progressively adjusted according to the predefined study protocol. The exercise period is followed by a 16-minute recovery period without physical exercise. Cardiovascular and hemodynamic parameters are continuously or repeatedly recorded throughout the pre-exercise, exercise, and recovery phases.
Change in Perfusion Index (PI) during and after Standardized Bicycle Ergometer Exercise
The perfusion index (PI) will be continuously recorded using the VitaGuard 3100 (Getemed, Teltow, Germany) at a sampling rate of 1 Hz. PI values will be averaged over 1-minute intervals. Within-participant changes in PI will be assessed across the pre-exercise resting phase, graded bicycle ergometer exercise at 30% to 90% of the participant's individual maximum exercise capacity, and the post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
SDNN, expressed in milliseconds (ms), will be derived from single-lead electrocardiographic recordings and calculated as the standard deviation of all normal-to-normal (NN) intervals. Changes in SDNN will be assessed between the pre-exercise resting phase, the exercise phase, and the post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Root Mean Square of Successive Differences (RMSSD)
RMSSD, expressed in milliseconds (ms), will be derived from normal-to-normal intervals obtained from single-lead electrocardiographic recordings and calculated as the root mean square of successive differences between adjacent NN intervals. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Relative Very-Low-Frequency Heart Rate Variability Power (VLF%)
Relative very-low-frequency (VLF) power will be derived from frequency-domain analysis of heart rate variability. VLF is defined as the frequency range from 0.003 to 0.04 Hz and will be expressed as relative power (%). Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Relative High-Frequency Heart Rate Variability Power (HF%)
Relative high-frequency (HF) power will be derived from frequency-domain analysis of heart rate variability. HF is defined as power within the frequency range of 0.15 to 0.40 Hz. Relative HF power will be calculated as HF/(Total Power - VLF) × 100 and expressed as percent. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Low-Frequency to High-Frequency Power Ratio (LF/HF Ratio)
The LF/HF ratio will be calculated from frequency-domain heart rate variability analysis as the ratio of low-frequency power (0.04-0.15 Hz) to high-frequency power (0.15-0.40 Hz). Changes in the LF/HF ratio will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Pulse Transit Time (PTT)
Pulse transit time (PTT), expressed in milliseconds (ms), will be determined using simultaneous electrocardiographic and photoplethysmographic recordings with the VitaGuard 3100. PTT is defined as the time interval from the R-wave of the electrocardiogram to the 50% rise point of the subsequent peripheral pulse wave. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Peripheral Systolic Blood Pressure
Peripheral systolic blood pressure, expressed in mmHg, will be measured noninvasively at the right upper arm at 2-minute intervals using a Schiller MT300 Light-Holter-BPR device. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline, every 2 minutes during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Peripheral Diastolic Blood Pressure
Peripheral diastolic blood pressure, expressed in mmHg, will be measured noninvasively at the right upper arm at 2-minute intervals using a Schiller MT300 Light-Holter-BPR device. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline, every 2 minutes during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Pulse-to-Respiration Ratio
The pulse-to-respiration ratio will be calculated as the ratio of heart rate to respiratory rate. Changes in the ratio will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Photoplethysmographic Stiffness Index (SI)
The photoplethysmographic Stiffness Index (SI) will be determined from the digital volume pulse recorded at the fingertip using the Micro Medical PulseTrace PWV PT6000. The SI is derived from the time interval between the systolic and reflected components of the photoplethysmographic pulse wave form. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Photoplethysmographic Reflection Index (RI)
The photoplethysmographic Reflection Index (RI) will be determined from the digital volume pulse recorded at the fingertip using the PulseTrace PT6000. RI is calculated from the amplitude of the reflected pulse-wave component relative to the amplitude of the first systolic component and is expressed as percent. Changes will be assessed across the pre-exercise, exercise, and post-exercise recovery phases.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Pleth Variability Index (PVI)
The Pleth Variability Index (PVI) will be measured using a Masimo Radical-7 pulse oximeter with a finger sensor. Changes in PVI will be assessed across the pre-exercise resting phase, the bicycle ergometer exercise phase, and the post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Difference in Peripheral Oxygen Saturation Between Forehead and Finger Sensor Locations
Peripheral oxygen saturation (SpO2), expressed as percent, will be measured simultaneously at the forehead and finger. Within-participant differences between forehead and finger measurements will be assessed separately for the Masimo and Nellcor pulse oximetry systems during the pre-exercise resting phase, bicycle ergometer exercise, and post-exercise recovery.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Difference in Peripheral Oxygen Saturation Between Masimo and Nellcor Pulse Oximetry Systems
Peripheral oxygen saturation (SpO2), expressed as percent, will be measured simultaneously using Masimo Lnop-TF-I and Nellcor N-600 pulse oximetry systems. Within-participant differences between the two systems will be assessed separately for forehead and finger sensor locations during the pre-exercise resting phase, bicycle ergometer exercise, and post-exercise recovery.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
Change in Mean Normal-to-Normal Interval (Mean NN)
Mean NN interval, expressed in milliseconds (ms), will be derived from single-lead electrocardiographic recordings and calculated as the arithmetic mean of all normal-to-normal (NN) intervals within the respective analysis period. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Change in Percentage of Successive NN Intervals Differing by More Than 50 ms (pNN50)
pNN50, expressed as percent (%), will be calculated as the percentage of successive pairs of normal-to-normal (NN) intervals that differ by more than 50 milliseconds. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Change in Total Heart Rate Variability Power
Total Power, expressed in milliseconds squared (ms²), will be derived from frequency-domain analysis of normal-to-normal intervals and represents the overall spectral power within the analyzed frequency range. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Change in Ultra-Low-Frequency Heart Rate Variability Power (ULF Power)
Ultra-low-frequency (ULF) power, expressed in milliseconds squared (ms²), will be derived from frequency-domain analysis of heart rate variability and defined as spectral power in the frequency range above 0 and below 0.003 Hz. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Change in Very-Low-Frequency Heart Rate Variability Power (VLF Power)
Very-low-frequency (VLF) power, expressed in milliseconds squared (ms²), will be derived from frequency-domain analysis of heart rate variability and defined as spectral power within the frequency range of 0.003 to 0.04 Hz. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Change in Low-Frequency Heart Rate Variability Power (LF Power)
Low-frequency (LF) power, expressed in milliseconds squared (ms²), will be derived from frequency-domain analysis of heart rate variability and defined as spectral power within the frequency range of 0.04 to 0.15 Hz. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Change in High-Frequency Heart Rate Variability Power (HF Power)
High-frequency (HF) power, expressed in milliseconds squared (ms²), will be derived from frequency-domain analysis of heart rate variability and defined as spectral power within the frequency range of 0.15 to 0.40 Hz. Changes will be assessed across the pre-exercise resting phase, exercise phase, and post-exercise recovery phase.
Time frame: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.
Plan to share: Yes — Deidentified individual participant data will be made available, in addition to study protocol.
Supporting information: Study protocol
Time frame: The data will be made available upon publication for a duration of three months.
Access criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
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Ran from May 2007 to primary completion in Jun 2007, 0 months.
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ARCIM Institute Academic Research in Complementary and Integrative Medicine