Effects of Standardized Physical Exercise on a Bicycle Ergometer on the Perfusion Index (PI) and Other Cardiovascular ParametersNCT07830615
Bicycle Ergometry and Peripheral Hemodynamics: a Pilot Study
A study testing Standardized Bicycle Ergometer Exercise in people with Effects of Standardized Physical Exercise on a Bicycle Ergometer on the Perfusion Index (PI) and Other Cardiovascular Parameters, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Standardized Physical Exercise on a Bicycle Ergometer on the Perfusion Index (PI) and Other Cardiovascular Parameters
- What is being tested?
- Standardized Bicycle Ergometer Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2007to 14 Jun 2007
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent for participation in the study
- Non-smoker
- Normal resting electrocardiogram and resting blood pressure not exceeding 140/90 mmHg
- No family history of myocardial infarction or sudden cardiac death in a first-degree relative younger than 60 years at the time of the event
Who cannot join
- Acute or chronic diseases, particularly cardiovascular conditions
- Use of conventional medications or recreational drugs
- Disorders of autonomic regulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Exercise (Bicycle Ergometer) on Peripheral Hemodynamics in Healthy Adult Male Volunteers: A Pilot Study
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.
Read the detailed description
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.
- Being tested
- Standardized Bicycle Ergometer Exercise
- Keywords
- Cardiovascular Parameters, Perfusion Index, Heart Rate Variability, Healthy participants, Bicycle Ergometry, Peripheral Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Bicycle Ergometer ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Bicycle Ergometer Exercise | Experimental | 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. Receives: Behavioral: Standardized Bicycle Ergometer Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start17 May 2007
- Primary completion14 Jun 2007
- Study completion14 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Standardized Physical Exercise on a Bicycle Ergometer on the Perfusion Index (PI) and Other Cardiovascular ParametersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, repeated-measures study in which all participants undergo the same standardized bicycle ergometer exercise protocol. Cardiovascular, hemodynamic, heart rate variability, photoplethysmographic, and pulse oximetry parameters are assessed before, during, and after exercise, allowing within-participant comparison across the pre-exercise, exercise, and post-exercise recovery phases.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Professor, Study director, ARCIM Institute Academic Research in Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830615
- Sponsor's protocol ID
- ERG_01
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise (Bicycle Ergometer) on Peripheral Hemodynamics in Healthy Adult Male Volunteers: A Pilot Study
- ClinicalTrials.gov ID
- NCT07830615
- Acronym / sponsor ID
- ERG_01
- Keywords
- Cardiovascular Parameters, Perfusion Index, Heart Rate Variability, Healthy participants, Bicycle Ergometry, Peripheral Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 17 May 2007 (actual)
- Primary completion
- 14 Jun 2007 (actual)
- Study completion
- 14 Jun 2007 (actual)
- First posted
- 21 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, repeated-measures study in which all participants undergo the same standardized bicycle ergometer exercise protocol. Cardiovascular, hemodynamic, heart rate variability, photoplethysmographic, and pulse oximetry parameters are assessed before, during, and after exercise, allowing within-participant comparison across the pre-exercise, exercise, and post-exercise recovery phases.
| Arm | Type | Receives |
|---|---|---|
| Standardized Bicycle Ergometer Exercise | Experimental | Behavioral: Standardized Bicycle Ergometer ExerciseHealthy 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent for participation in the study
- Non-smoker
- Normal resting electrocardiogram and resting blood pressure not exceeding 140/90 mmHg
- No family history of myocardial infarction or sudden cardiac death in a first-degree relative younger than 60 years at the time of the event
Key exclusion criteria (3 listed)
- Acute or chronic diseases, particularly cardiovascular conditions
- Use of conventional medications or recreational drugs
- Disorders of autonomic regulation
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 |
|---|---|---|
| Standardized Bicycle Ergometer ExerciseParticipants 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. | Behavioural | Standardized Bicycle Ergometer Exercise |
Primary outcome
Change in Perfusion Index (PI) during and after Standardized Bicycle Ergometer Exercise
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
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.
21 secondary outcomes
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
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)
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%)
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%)
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)
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)
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
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
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
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)
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)
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)
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
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
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)
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)
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
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)
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)
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)
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)
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.
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol.
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.
Jan Vagedes, Professor study director
ARCIM Institute Academic Research in Complementary and Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Bicycle Ergometer Exercise in people with Effects of Standardized Physical Exercise on a Bicycle Ergometer on the Perfusion Index (PI) and Other Cardiovascular Parameters, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
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 4 inclusion and 3 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 22 Sep 2026. 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 Germany. 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 Perfusion Index (PI) during and after Standardized Bicycle Ergometer Exercise (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.