Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:26 AM
Study NCT ID:
NCT06709560
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2024-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baroreflex Sensitivity Response to Exercise
Sponsor:
Egas Moniz - Cooperativa de Ensino Superior, CRL
Organization:
Study Overview
Official Title:
Sex Differences in Baroreflex Sensitivity Response to Different Constant-load Submaximal Exercise Intensities
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE MAKERS
Brief 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. 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:
1. Females will show higher HRV and BRS at rest compared to males, indicating better heart rate control.
2. During exercise, females will have greater cardiovagal (heart-related) activation than males, regardless of exercise intensity.
3. When exercise sessions are matched for blood pressure, there will be no significant sex differences in HRV and BRS responses.
4. 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.
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:
1. Females will show higher HRV and BRS at rest compared to males, indicating better heart rate control.
2. During exercise, females will have greater cardiovagal (heart-related) activation than males, regardless of exercise intensity.
3. When exercise sessions are matched for blood pressure, there will be no significant sex differences in HRV and BRS responses.
4. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: