Effects of Heart Rate Variability-guided Training vs Standard Aerobic Prescription on Cardiovagal Modulation and Cardiorespiratory Fitness in Coronary Artery Disease

NCT06919237 | Not Yet Recruiting

• 1 other identifier: ParaDox
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery disease (CAD) is associated with autonomic dysfunction and is characterized by reduced heart rate variability (HRV) and impaired heart rate recovery. Regular exercise improves cardiovascular outcomes in CAD, with high-intensity interval training (HIIT) showing superior benefits compared to moderate-intensity continuous training (MICT). However, the full potential of exercise is not used in the clinical context since some of the training principles are neglected, contributing to a high number of exercise non-responders. HRV-guided training has been identified as an alternative prescription technique for cardiovascular endurance exercise and has contributed to greater improvements compared to standard prescriptions. Thus, this study aims to assess the chronic effects of exercise on cardiovagal modulation, baroreflex sensitivity, arterial stiffness, and cardiorespiratory fitness in patients with CAD, specifically determining whether heart rate variability-guided training yields different outcomes compared to a traditional prescription in a 12-week exercise intervention. A total of 48 participants, will be recruited and randomized into one of 3 groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), and HRV-guided training. The intervention will consist of 12 weeks of supervised exercise, with 3 weekly sessions. Participants in the HRV-guided training group will have their exercise intensity adjusted based on their individual HRV profiles. Moderate- or high-intensity sessions are prescribed when the 7-day rolling average of LnRMSSD remains within the smallest worthwhile change (SWC). If it falls outside the SWC, low-intensity sessions or rest are recommended. In the HIIT group, sessions will consist of 4 bouts of 2 minutes at 80-90% HRR during the first 4 weeks, increasing to 6 bouts of 2 minutes at the same intensity in weeks 5-8, and progressing to 6 bouts of 2 minutes at 90% HRR in the final 4 weeks. In the MICT group, participants will perform continuous sessions starting with 2x10 minutes at 50-60% HRR in the first 4 weeks, progressing to 2x12 minutes at the same intensity in weeks 5-8, and increasing to 2x15 minutes at 60-70% HRR in the final phase. Cardiovagal modulation, cardiorespiratory fitness, BRS, and AS will be assessed at the baseline and after the 12 weeks of intervention. Most cardiac rehabilitation programs use the "one-size-fits-all" approach, which is a limitation of the literature, leading to a large number of exercise nonresponders to changes in cardiorespiratory fitness. HRV-guided training seems to be a more individualized method of aerobic prescription and may lead to greater improvements in cardiorespiratory fitness and in cardiovagal modulation. This study will contribute to generate evidence regarding aerobic exercise prescription in cardiac rehabilitation.

Conditions

Coronary Arterial Disease (CAD)

Keywords

Exercise prescription; arterial stiffness; heart rate variability; autonomic activity; maximal oxygen consumption; moderate-intensity continuous training; high-intensity interval training

Outcome Measures

Primary Outcomes (2)

• Cardiovagal modulation

  The R-R intervals will be derived from beat-to-beat blood pressure pulse intervals using finger plethysmography (Finapres Nova, Amsterdam, Netherlands), during all measures. Finger plethysmography-derived peak-to-peak intervals are highly correlated with electrocardiogram R-R intervals, with similar variability. The upstroke is determined using the pressure signal with a resolution of 2 ms, and the interval between the two consecutive upstrokes is measured. In the frequency domain, the two primary components are low-frequency (LF: 0.04-0.15 Hz) and high-frequency (HF: 0.15-0.40 Hz) spectra. Heart rate variability measures provide information primarily on vagal modulation with the LF power spectrum reflecting both sympathetic and parasympathetic modulation and HF reflecting the parasympathetic modulation of the R-R intervals. The LF/HF ratio is used as an indicator of sympathovagal dominance.

  pre and post intervention (12 weeks) assessments

• Cardiorespiratory fitness

  An incremental CPET will be performed on a treadmill (Pulsar 3p, HP Cosmos) with mixing-chamber gas exchange measurements (Quark RMR w/CPET, Italy), according to Bruce modified protocol. A 12-lead electrocardiogram will be continuously monitored, and blood pressure will be assessed by auscultation using an aneroid sphygmomanometer. A cardiologist and an exercise physiologist will supervise the CPET. Before each test, the gas analyzer will be calibrated using ambient air standard calibration gases of known concentrations (16,7% O2 and 5,7% CO2). The turbine flowmeter of Cosmed will be calibrated with a 3L syringe. Data will be analyzed in 20 s average, and peak VO2 will be defined as the highest value attained in the last minute of effort

  pre and post intervention (12 weeks) assessments

Secondary Outcomes (3)

• Baroreflex sensitivity

  pre and post intervention (12 weeks) assessments

• Local arterial stiffness

  pre and post intervention (12 weeks) assessments

• Regional Arterial Stiffness

  pre and post intervention (12 weeks) assessments

Other Outcomes (2)

• Body composition

  pre and post intervention (12 weeks) assessments

• Free living physical activity

  during one week

Study Arms (3)

HIIT (training/Behavioral)

EXPERIMENTAL

Over the first 4 weeks, participants will perform 4 bouts of 2 min of high-intensity exercise at 80-90% heart rate reserve (HRR), during the next 4 weeks, participants will perform 6 bouts of 2 min of high-intensity exercise at 80-90%HRR, while in the last 4 weeks participants will perform 6 bouts of 2 min of high-intensity exercise at 90%HRR). Exercise bouts will be interspersed by 2 min of active recovery at 50-60% HRR.

Other: HIIT Intervention

MICT (training/Behavioral)

EXPERIMENTAL

Over the first 4 weeks participants in MICT will perform continuous exercise at 50-60% HRR (2x10'), during the next 4 weeks participants will perform continuous exercise at 50-60% HRR (2x12'), while in the last 4 weeks participants will perform continuous exercise at 60-70% HRR (2x15').

Other: MICT Intervention

HRV-Guided Training (training/Behavioral)

EXPERIMENTAL

Following a 10-day initial characterization period, where the HRV is measured with plethysmography continually during the night, with "Whoop" (https://www.whoop.com) device, the individual HRV profile is defined, still, participants will use the Whoop during all intervention to allow the updating of HRV profile. Then, considering the daily individual autonomic regulation, following a decision-making schema modified from Kiviniemi et al., (2007) \[21\], exercise intensity will be defined for the training session, i.e., if LnRMSSD7day-roll-avg remained inside the smallest worthwhile change (SWC) (SWC = 0.5 × standard deviation), high intensity or moderate-intensity training sessions is prescribed, if LnRMSSD7day-roll-avg fell outside SWC, low intensity or rest is prescribed, leading to different workloads from the predefined training programs.

Other: HRV-Guided Intervention

Interventions

HIIT Intervention OTHER

Over the first 4 weeks, participants will perform 4 bouts of 2 min of high-intensity exercise at 80-90% heart rate reserve (HRR), during the next 4 weeks, participants will perform 6 bouts of 2 min of high-intensity exercise at 80-90%HRR, while in the last 4 weeks participants will perform 6 bouts of 2 min of high-intensity exercise at 90%HRR). Exercise bouts will be interspersed by 2 min of active recovery at 50-60% HRR.

HIIT (training/Behavioral)

MICT Intervention OTHER

Over the first 4 weeks participants in MICT will perform continuous exercise at 50-60% HRR (2x10'), during the next 4 weeks participants will perform continuous exercise at 50-60% HRR (2x12'), while in the last 4 weeks participants will perform continuous exercise at 60-70% HRR (2x15').

MICT (training/Behavioral)

HRV-Guided Intervention OTHER

Following a 10-day initial characterization period, where the HRV is measured with plethysmography continually during the night, with "Whoop" (https://www.whoop.com) device, the individual HRV profile is defined, still, participants will use the Whoop during all intervention to allow the updating of HRV profile. Then, considering the daily individual autonomic regulation, following a decision-making schema modified from Kiviniemi et al., (2007) \[21\], exercise intensity will be defined for the training session, i.e., if LnRMSSD7day-roll-avg remained inside the smallest worthwhile change (SWC) (SWC = 0.5 × standard deviation), high intensity or moderate-intensity training sessions is prescribed, if LnRMSSD7day-roll-avg fell outside SWC, low intensity or rest is prescribed, leading to different workloads from the predefined training programs.

HRV-Guided Training (training/Behavioral)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged over 18 years;
• had angiographically documented CAD in at least one major epicardial vessel;
• clinical evidence of CAD in the form of previous myocardial infarction;
• clinical evidence of CAD in the form of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention);
• clinical evidence of CAD in the form of angina pectoris.

You may not qualify if:

• heart failure;
• cardiac implantable defibrillators;
• resynchronizing devices;
• inability to comply with guidelines for participation in exercise testing and training.

Sponsors & Collaborators

• Faculdade de Motricidade Humana: lead
• Fundação para a Ciência e a Tecnologia (FCT): collaborator

Study Sites (1)

Faculdade de Motricidade Humana

Lisbon, Lisbon District, 1495-688, Portugal

Location

Related Publications (34)

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Study Officials

• Helena Santa-Clara, PhD

  Faculdade de Motricidade Humana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Pedro, Masters

CONTACT

+ 351 966973481; mpedro661@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD project)

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

PT (1)