Baroreflex Sensitivity Response to Exercise

NCT06709560 | Completed

• 1 other identifier: PACE MAKERS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Females will show higher HRV and BRS at rest compared to males, indicating better heart rate control.
2. 2.During exercise, females will have greater cardiovagal (heart-related) activation than males, regardless of exercise intensity.
3. 3.When exercise sessions are matched for blood pressure, there will be no significant sex differences in HRV and BRS responses.
4. 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.

Conditions

Sex

Keywords

Hear Rate Variability; Baroreflex Sensitivity; Exercise Intensity; Acute Exercise; Sex Differences

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  At rest in each visit to the laboratory, just before the 6 minutes bouts of MICE and VICE

• Central Blood Pressure

  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

  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

  At rest and in the last 2 minutes of the 6 minutes bout of moderate intensity continuous exercise and high intensity continuous exercise

Study Arms (2)

Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription

ACTIVE COMPARATOR

The exercise intensity is based solely on HRR.

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.

Other: Moderate Intensity Continuous Exercise Matched for Blood Pressure; Other: Vigorous Intensity Continuous Exercise Matched for Blood Pressure

Interventions

Moderate Intensity Continuous Exercise OTHER

Participants perform a continuous cycling exercise session on a reclined ergometer at moderate intensity (50% HRR)

Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription

Vigorous Intensity Continuous Exercise OTHER

Participants perform a continuous cycling exercise session on a reclined ergometer, at a vigorous intensity (80% HRR).

Heart Rate Reserve (HRR)-Based Exercise Intensity Prescription

Moderate Intensity Continuous Exercise Matched for Blood Pressure OTHER

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).

Blood Pressure-Matched Exercise Intensity Prescription

Vigorous Intensity Continuous Exercise Matched for Blood Pressure OTHER

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).

Blood Pressure-Matched Exercise Intensity Prescription

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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+).

You may not qualify if:

• Smoking
• Diagnosed with cardiac, metabolic or renal diseases
• Taking cardioactive medication
• Resting hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \> 90 mmHg).

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• Faculdade de Motricidade Humana: collaborator

Study Sites (1)

Ginásio Clube Português

Lisbon, Portugal

Location

Related Publications (5)

• 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.

  PMID: 30907327 BACKGROUND

• Seo 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.

  PMID: 38380301 BACKGROUND

• Schumann 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.

  PMID: 37947436 BACKGROUND

• Wheatley 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.

  PMID: 25191635 BACKGROUND

• Fu 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.

  PMID: 31721084 BACKGROUND

MeSH Terms

Conditions

Coitus

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to the order of the visits until arrival at the laboratory.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 29, 2024
• Study Start: January 2, 2023
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact xmelo@egasmoniz.edu.pt

Locations

PT (1)