SexPACE MAKERSNCT06709560
Baroreflex Sensitivity Response to Exercise
A study testing Moderate Intensity Continuous Exercise, Vigorous Intensity Continuous Exercise and Moderate Intensity Continuous Exercise Matched for Blood Pressure in people with Sex, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
Males and females show distinct differences in cardiovascular function, especially during exercise. Evidence suggests that females generally have lower blood pressure due to hormonal influences that reduce blood vessel constriction. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Sex
- What is being tested?
- Moderate Intensity Continuous Exercise, Vigorous Intensity Continuous Exercise and Moderate Intensity Continuous Exercise Matched for Blood Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2023to 28 Jul 2023
- 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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 18 to 44 years old.
- Physical active as assessed by the International Physical Activity Questionnaire (IPAQ).
- Low risk to increase physical Activity as assessed by the Physical Activity Readiness Questionnaire (PAR-Q+).
Who cannot join
- Smoking
- Diagnosed with cardiac, metabolic or renal diseases
- Taking cardioactive medication
- Resting hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex Differences in Baroreflex Sensitivity Response to Different Constant-load Submaximal Exercise Intensities
Males and females show distinct differences in cardiovascular function, especially during exercise. Evidence suggests that females generally have lower blood pressure due to hormonal influences that reduce blood vessel constriction. This protective effect may contribute to a lower risk of high blood pressure and cardiovascular diseases in females compared to males. Additionally, females tend to have different patterns of heart rate control and blood pressure regulation, largely due to differences in the autonomic nervous system and hormonal balance.
One key mechanism involved in blood pressure control is the baroreflex, which helps stabilize blood pressure by adjusting heart rate and blood vessel function. The sensitivity of the baroreflex (known as baroreflex sensitivity, or BRS) can vary between males and females. For instance, females may exhibit slower adjustments in heart rate in response to blood pressure changes, but they also tend to have better blood pressure regulation during moderate exercise.
Read more
The main purpose of this study is to explore whether these sex-specific differences extend to more intense exercise. Investigators will compare the responses of young, active males and females to cycling at two exercise intensities: moderate (50% of Heart Rate Reserve, HRR) and vigorous (80% HRR). As a secondary purpose, investigators we will assess the inter-day repeatability of HRV and BRS parameters measured at rest and during moderate and vigorous intensity exercise utilizing sequence and spectral indices in apparently healthy young adult males and females.
We hypothesize that:
- Females will show higher HRV and BRS at rest compared to males, indicating better heart rate control.
- During exercise, females will have greater cardiovagal (heart-related) activation than males, regardless of exercise intensity.
- When exercise sessions are matched for blood pressure, there will be no significant sex differences in HRV and BRS responses.
- Sequential methods techniques can be used to assess cardiovagal BRS and HRV changes between days during exercise in young adults, regardless of their sex. In addition, the inclusion of vigorous intensity may improve the repeatability of the outcome measure due to sympathetic outflow predominance.
Read the detailed description
Forty healthy and physically active participants (20 males and 20 females) aged 18-31 were recruited for this study. All participants reported to the laboratory in a fasted state (>4 hours) and refrained from consuming foods or drinks containing caffeine or alcohol for at least 12 hours. They also avoided strenuous exercise for at least 24 hours prior to the testing sessions. The menstrual cycle was not controlled for female participants. All participants provided written informed consent after receiving a detailed explanation of the study's aims and experimental procedures.
This study was constructed as a crossover trial. Participants attended 4 separate intervention sessions. On the first visit, participants had their body composition evaluated by a clinical bioimpedance device using 8 electrodes positioned on each hand and foot. Each participant also performed a ramp incremental cycle ergometer test to exhaustion on a recumbent stationary cycle ergometer (Excite Recline Med, TechnoGym, Italy). On the second and third visit, participants quietly rested for 15 min in the supine position to evaluate heart rate variability (HRV) using a 5-ECG lead module (Nova, Finapres Measurement Systems, Amsterdam, The Netherlands), carotid (Arietta V60 ultrasound; Aloka/Hitachi Medical Systems) and aortic (Complior Analyse software (ALAM Medical, Paris, France) arterial stiffness. Participants then performed a 6 minutes bout of moderate intensity continuous exercise (MICE) at 50% heart rate reserve [HRR= 0.5*(HRmax- HRrest) + HRrest] followed by a 6 minutes vigorous intensity continuous exercise (VICE) bout at 80% HRR on a recumbent stationary bike, while having their HRV, beat-by-beat blood pressure and carotid arterial stiffness evaluated at HR steady state at each intensity. Visits 2 and 3 provided the data for the repeatability objective and hypothesis. On the fourth visit, the participants performed an acute bout of MICE and VICE, but this time at the corresponding average blood pressure at each intensity from visits 2 and 3. As men show higher blood pressure values during exercise, in the fourth visit we matched their intensity of exercise with the average blood pressure attained by women during steady state at each intensity.
Blood pressure and HR were monitored beat-by-beat and carotid arterial stiffness was measured at BP steady-state.
All visits were conducted in the morning with each participant performing sessions at the same time of the day to minimize any potential diurnal variation.
- Conditions
- Sex
- Being tested
- Moderate Intensity Continuous Exercise, Vigorous Intensity Continuous Exercise, Moderate Intensity Continuous Exercise Matched for Blood Pressure, Vigorous Intensity Continuous Exercise Matched for Blood Pressure
- Keywords
- Hear Rate Variability, Baroreflex Sensitivity, Exercise Intensity, Acute Exercise, Sex Differences
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Continuous ExerciseOther
Participants perform a continuous cycling exercise session on a reclined ergometer at moderate intensity (50% HRR)
Vigorous Intensity Continuous ExerciseOther
Participants perform a continuous cycling exercise session on a reclined ergometer, at a vigorous intensity (80% HRR).
Moderate Intensity Continuous Exercise Matched for Blood PressureOther
Participants perform a cycling session where exercise intensity is adjusted to match the systolic blood pressure levels attained during the first visit at moderate intensity (50% HRR).
Vigorous Intensity Continuous Exercise Matched for Blood PressureOther
Participants perform a different cycling session where exercise intensity is adjusted to match the systolic blood pressure levels attained during the first visit at vigorous intensity (80% HRR).
| Study group | Role | What they receive |
|---|---|---|
| Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription | Active comparator | The exercise intensity is based solely on HRR. Receives: Other: Moderate Intensity Continuous Exercise; Other: Vigorous Intensity Continuous Exercise |
| Blood Pressure-Matched Exercise Intensity Prescription | Experimental | Instead of relying on HRR, exercise intensity is tailored to replicate the average systolic blood pressure achieved in the initial HRR-based session. Receives: Other: Moderate Intensity Continuous Exercise Matched for Blood Pressure; Other: Vigorous Intensity Continuous Exercise Matched for Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Heart Rate Variability
R-R intervals were derived from beat-to-beat blood pressure pulse intervals using finger plethysmography (Finapres® Nova, Amsterdam, Netherlands) at rest and during exercise across all visits. The pressure signal's upstroke was identified with a 2 ms resolution, and the interval between consecutive upstrokes was measured. In the frequency domain, low-frequency (LF; 0.04-0.15 Hz) reflected sympathetic and parasympathetic modulation, while high-frequency (HF; 0.15-0.40 Hz) served as a marker of parasympathetic modulation. The LF/HF ratio indicated sympathovagal dominance. Data acquisition and analysis were conducted following the Task Force guidelines of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.
Measured: At rest and in the last 2 minutes of the 6 minutes bout of MICE and VICE
Changes in Baroreflex sensitivity
A spectral method was used to compute baroreflex sensitivity as the transfer gain of the cross-spectra between pressure and interval at rest and during exercise across all visits. Coherence was typically high in the 10 s rhythm band (0.06-0.15 Hz) and at ventilatory frequencies (0.15-0.5 Hz). Spectral estimates of the recordings were computed using the Finapres® Nova device software (Amsterdam, Netherlands), which provided an easy-to-use interface. A discrete Fourier transform, requiring no interpolation or zero padding, was applied. Triangular spectral smoothing was set at a width of 10, reflecting the 10-minute duration of the recordings. Spectral density, coherence, pressure-interval transfer gain, and phase plots were displayed on the device screen, with a cursor allowing manual selection of bands with high coherence and spectral power. An output program listed the resultant data and all selections made for subsequent analysis.
Measured: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
Secondary outcomes (4)
Regional Arterial Stiffness
Arterial stiffness was measured by pulse wave velocity (PWV) using applanation tonometry. The distance between the carotid and femoral arteries was measured directly and entered into the Complior Analyse software (ALAM Medical, Paris, France) with a correction factor of 0.8. Right brachial blood pressure was measured twice and entered into the software before initiating signal acquisition. The operator positioned the carotid sensor using its holder and manually held the femoral and distal posterior tibial sensors. When 10 high-quality carotid pulse waveforms were observed, simultaneous carotid and femoral pressure curves were recorded for 10 pulse waveforms. The transit time between the two waveforms was automatically calculated. Values from the carotid to femoral artery were used as an index of central/aortic arterial stiffness.
Measured: At rest in each visit to the laboratory, just before the 6 minutes bouts of MICE and VICE
Central Blood Pressure
Carotid Systolic Blood Pressure (SBP) was assessed from right carotid traces acquired by applanation tonometry (Complior Analyse). The waveforms were averaged, and the mean values will be extracted from 15 s window of acquisition. The carotid waveforms were calibrated from MAP and brachial SBP, measured immediately before the acquisition.
Measured: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
Changes in Local Arterial Stiffness
Carotid arterial stiffness indices were assessed using eTRACKING technology. Common carotid diameter values and diameter-derived pressure data calculated Peterson's pressure-strain elastic modulus (ε) and stiffness index (β) using published algorithms. The augmentation index (AIx), reflecting arterial wave reflection, was calculated as the ratio of augmented pressure (difference between the carotid pressure curve "shoulder" and peak systolic pressure) to pulse pressure. AIx was derived using the third derivative method to locate the pulse inflection point. Measurements were performed at rest and during exercise across all visits.
Measured: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
Changes in Carotid Blood Pressure Wave Intensity
Wave intensity was calculated as the product of the derivatives of simultaneously recorded blood pressure and blood flow velocity changes, obtained at specific circulatory points. Blood pressure waveforms were derived non-invasively using a system developed by Hitachi, leveraging the correlation between cyclic blood pressure and vessel diameter changes.
The right common carotid artery was scanned using an Arietta V60 ultrasound machine (Hitachi Aloka Medical Ltd, Mitaka-shi, Tokyo, Japan) with a 7.5 MHz linear probe and a 5 MHz Doppler transducer at rest and during exercise. The intima-media borders were tracked using high-resolution wall tracking at 1 kHz. Arterial pressure waveforms were calibrated with sphygmomanometry, and flow velocity was recorded using Doppler ultrasound. Data were averaged from approximately 20 beats to derive waveforms and net wave intensity.
Measured: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start2 Jan 2023
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SexStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Motricidade Humana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709560
- Sponsor's protocol ID
- PACE MAKERS
- Acronym
- PACE MAKERS
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained in this study may be provided to qualified researchers with academic interest in the effects of acute exercise on the autonomic function. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Bassareo PP, Crisafulli A. Gender Differences in Hemodynamic Regulation and Cardiovascular Adaptations to Dynamic Exercise. Curr Cardiol Rev. 2020;16(1):65-72. doi: 10.2174/1573403X15666190321141856.
PubMed 30907327Seo MW, Park TY, Jung H. Sex Differences in Heart Rate Variability and Vascular Function Following High-Intensity Interval Training in Young Adults. J Hum Kinet. 2023 Oct 11;90:89-100. doi: 10.5114/jhk/170964. eCollection 2024 Jan.
PubMed 38380301Schumann A, Gupta Y, Gerstorf D, Demuth I, Bar KJ. Sex differences in the age-related decrease of spontaneous baroreflex function in healthy individuals. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H158-H165. doi: 10.1152/ajpheart.00648.2023. Epub 2023 Nov 10.
PubMed 37947436Wheatley CM, Snyder EM, Johnson BD, Olson TP. Sex differences in cardiovascular function during submaximal exercise in humans. Springerplus. 2014 Aug 20;3:445. doi: 10.1186/2193-1801-3-445. eCollection 2014.
PubMed 25191635Fu Q, Ogoh S. Sex differences in baroreflex function in health and disease. J Physiol Sci. 2019 Nov;69(6):851-859. doi: 10.1007/s12576-019-00727-z. Epub 2019 Nov 12.
PubMed 31721084
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Baroreflex Sensitivity Response to Different Constant-load Submaximal Exercise Intensities
- ClinicalTrials.gov ID
- NCT06709560
- Acronym / sponsor ID
- PACE MAKERS / PACE MAKERS
- Conditions
- Sex
- Keywords
- Hear Rate Variability, Baroreflex Sensitivity, Exercise Intensity, Acute Exercise, Sex Differences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- Faculdade de Motricidade Humana
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 29 Nov 2024 (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.
Males and females show distinct differences in cardiovascular function, especially during exercise. Evidence suggests that females generally have lower blood pressure due to hormonal influences that reduce blood vessel constriction. This protective effect may contribute to a lower risk of high blood pressure and cardiovascular diseases in females compared to males. Additionally, females tend to have different patterns of heart rate control and blood pressure regulation, largely due to differences in the autonomic nervous system and hormonal balance.
One key mechanism involved in blood pressure control is the baroreflex, which helps stabilize blood pressure by adjusting heart rate and blood vessel function. The sensitivity of the baroreflex (known as baroreflex sensitivity, or BRS) can vary between males and females. For instance, females may exhibit slower adjustments in heart rate in response to blood pressure changes, but they also tend to have better blood pressure regulation during moderate exercise.
The main purpose of this study is to explore whether these sex-specific differences extend to more intense exercise. Investigators will compare the responses of young, active males and females to cycling at two exercise intensities: moderate (50% of Heart Rate Reserve, HRR) and vigorous (80% HRR). As a secondary purpose, investigators we will assess the inter-day repeatability of HRV and BRS parameters measured at rest and during moderate and vigorous intensity exercise utilizing sequence and spectral indices in apparently healthy young adult males and females.
We hypothesize that:
- Females will show higher HRV and BRS at rest compared to males, indicating better heart rate control.
- During exercise, females will have greater cardiovagal (heart-related) activation than males, regardless of exercise intensity.
- When exercise sessions are matched for blood pressure, there will be no significant sex differences in HRV and BRS responses.
- Sequential methods techniques can be used to assess cardiovagal BRS and HRV changes between days during exercise in young adults, regardless of their sex. In addition, the inclusion of vigorous intensity may improve the repeatability of the outcome measure due to sympathetic outflow predominance.
Detailed description
Forty healthy and physically active participants (20 males and 20 females) aged 18-31 were recruited for this study. All participants reported to the laboratory in a fasted state (>4 hours) and refrained from consuming foods or drinks containing caffeine or alcohol for at least 12 hours. They also avoided strenuous exercise for at least 24 hours prior to the testing sessions. The menstrual cycle was not controlled for female participants. All participants provided written informed consent after receiving a detailed explanation of the study's aims and experimental procedures.
This study was constructed as a crossover trial. Participants attended 4 separate intervention sessions. On the first visit, participants had their body composition evaluated by a clinical bioimpedance device using 8 electrodes positioned on each hand and foot. Each participant also performed a ramp incremental cycle ergometer test to exhaustion on a recumbent stationary cycle ergometer (Excite Recline Med, TechnoGym, Italy). On the second and third visit, participants quietly rested for 15 min in the supine position to evaluate heart rate variability (HRV) using a 5-ECG lead module (Nova, Finapres Measurement Systems, Amsterdam, The Netherlands), carotid (Arietta V60 ultrasound; Aloka/Hitachi Medical Systems) and aortic (Complior Analyse software (ALAM Medical, Paris, France) arterial stiffness. Participants then performed a 6 minutes bout of moderate intensity continuous exercise (MICE) at 50% heart rate reserve [HRR= 0.5*(HRmax- HRrest) + HRrest] followed by a 6 minutes vigorous intensity continuous exercise (VICE) bout at 80% HRR on a recumbent stationary bike, while having their HRV, beat-by-beat blood pressure and carotid arterial stiffness evaluated at HR steady state at each intensity. Visits 2 and 3 provided the data for the repeatability objective and hypothesis. On the fourth visit, the participants performed an acute bout of MICE and VICE, but this time at the corresponding average blood pressure at each intensity from visits 2 and 3. As men show higher blood pressure values during exercise, in the fourth visit we matched their intensity of exercise with the average blood pressure attained by women during steady state at each intensity.
Blood pressure and HR were monitored beat-by-beat and carotid arterial stiffness was measured at BP steady-state.
All visits were conducted in the morning with each participant performing sessions at the same time of the day to minimize any potential diurnal variation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription | Active comparator | Other: Moderate Intensity Continuous Exercise, Other: Vigorous Intensity Continuous ExerciseThe exercise intensity is based solely on HRR. |
| Blood Pressure-Matched Exercise Intensity Prescription | Experimental | Other: Moderate Intensity Continuous Exercise Matched for Blood Pressure, Other: Vigorous Intensity Continuous Exercise Matched for Blood PressureInstead of relying on HRR, exercise intensity is tailored to replicate the average systolic blood pressure achieved in the initial HRR-based session. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females aged 18 to 44 years old.
- Physical active as assessed by the International Physical Activity Questionnaire (IPAQ).
- Low risk to increase physical Activity as assessed by the Physical Activity Readiness Questionnaire (PAR-Q+).
Key exclusion criteria (4 listed)
- Smoking
- Diagnosed with cardiac, metabolic or renal diseases
- Taking cardioactive medication
- Resting hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg).
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 |
|---|---|---|
| Moderate Intensity Continuous ExerciseParticipants perform a continuous cycling exercise session on a reclined ergometer at moderate intensity (50% HRR) | Other | Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription |
| Vigorous Intensity Continuous ExerciseParticipants perform a continuous cycling exercise session on a reclined ergometer, at a vigorous intensity (80% HRR). | Other | Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription |
| Moderate Intensity Continuous Exercise Matched for Blood PressureParticipants perform a cycling session where exercise intensity is adjusted to match the systolic blood pressure levels attained during the first visit at moderate intensity (50% HRR). | Other | Blood Pressure-Matched Exercise Intensity Prescription |
| Vigorous Intensity Continuous Exercise Matched for Blood PressureParticipants perform a different cycling session where exercise intensity is adjusted to match the systolic blood pressure levels attained during the first visit at vigorous intensity (80% HRR). | Other | Blood Pressure-Matched Exercise Intensity Prescription |
Primary outcome
Changes in Heart Rate Variability
Time frame: At rest and in the last 2 minutes of the 6 minutes bout of MICE and VICE
R-R intervals were derived from beat-to-beat blood pressure pulse intervals using finger plethysmography (Finapres® Nova, Amsterdam, Netherlands) at rest and during exercise across all visits. The pressure signal's upstroke was identified with a 2 ms resolution, and the interval between consecutive upstrokes was measured. In the frequency domain, low-frequency (LF; 0.04-0.15 Hz) reflected sympathetic and parasympathetic modulation, while high-frequency (HF; 0.15-0.40 Hz) served as a marker of parasympathetic modulation. The LF/HF ratio indicated sympathovagal dominance. Data acquisition and analysis were conducted following the Task Force guidelines of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.
Changes in Baroreflex sensitivity
Time frame: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
A spectral method was used to compute baroreflex sensitivity as the transfer gain of the cross-spectra between pressure and interval at rest and during exercise across all visits. Coherence was typically high in the 10 s rhythm band (0.06-0.15 Hz) and at ventilatory frequencies (0.15-0.5 Hz). Spectral estimates of the recordings were computed using the Finapres® Nova device software (Amsterdam, Netherlands), which provided an easy-to-use interface. A discrete Fourier transform, requiring no interpolation or zero padding, was applied. Triangular spectral smoothing was set at a width of 10, reflecting the 10-minute duration of the recordings. Spectral density, coherence, pressure-interval transfer gain, and phase plots were displayed on the device screen, with a cursor allowing manual selection of bands with high coherence and spectral power. An output program listed the resultant data and all selections made for subsequent analysis.
4 secondary outcomes
Regional Arterial Stiffness
Time frame: At rest in each visit to the laboratory, just before the 6 minutes bouts of MICE and VICE
Central Blood Pressure
Time frame: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
Changes in Local Arterial Stiffness
Time frame: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
Changes in Carotid Blood Pressure Wave Intensity
Time frame: At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise
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 29 Nov 2024.
- Background: PubMed 30907327Bassareo PP, Crisafulli A. Gender Differences in Hemodynamic Regulation and Cardiovascular Adaptations to Dynamic Exercise. Curr Cardiol Rev. 2020;16(1):65-72. doi: 10.2174/1573403X15666190321141856.
- Background: PubMed 38380301Seo MW, Park TY, Jung H. Sex Differences in Heart Rate Variability and Vascular Function Following High-Intensity Interval Training in Young Adults. J Hum Kinet. 2023 Oct 11;90:89-100. doi: 10.5114/jhk/170964. eCollection 2024 Jan.
- Background: PubMed 37947436Schumann A, Gupta Y, Gerstorf D, Demuth I, Bar KJ. Sex differences in the age-related decrease of spontaneous baroreflex function in healthy individuals. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H158-H165. doi: 10.1152/ajpheart.00648.2023. Epub 2023 Nov 10.
- Background: PubMed 25191635Wheatley CM, Snyder EM, Johnson BD, Olson TP. Sex differences in cardiovascular function during submaximal exercise in humans. Springerplus. 2014 Aug 20;3:445. doi: 10.1186/2193-1801-3-445. eCollection 2014.
- Background: PubMed 31721084Fu Q, Ogoh S. Sex differences in baroreflex function in health and disease. J Physiol Sci. 2019 Nov;69(6):851-859. doi: 10.1007/s12576-019-00727-z. Epub 2019 Nov 12.
- Individual participant dataSharing planned: Yes. Data obtained in this study may be provided to qualified researchers with academic interest in the effects of acute exercise on the autonomic function. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Continuous Exercise, Vigorous Intensity Continuous Exercise and Moderate Intensity Continuous Exercise Matched for Blood Pressure in people with Sex, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 3 inclusion and 4 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 29 Nov 2024. 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 Portugal. 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?
Changes in Heart Rate Variability (time frame: At rest and in the last 2 minutes of the 6 minutes bout of MICE and VICE). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709560, which also lists 5 linked publications.
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 29 Nov 2024.