Chronic Adaptations in Cardiovagal Modulation and Cardiorespiratory Fitness in Patients With Coronary Artery Disease to a 12-week Heart Rate Variability-guided Training vs Traditional Aerobic Prescription Program: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cardiovagal modulation
研究概览
简要总结
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.
详细描述
Background
Coronary artery disease (CAD) is characterized by the inability to adequately supply blood and oxygen to the heart, often resulting from the formation of atherosclerotic plaques within the arterial lumen. This inflammatory, multifactorial condition can impair the autonomic nervous system (ANS), disrupting the balance between the sympathetic and parasympathetic pathways and leading to autonomic dysfunction. Key indicators of this dysfunction include reduced heart rate variability (HRV) and delayed heart rate recovery, both of which signify heightened sympathetic activity and diminished parasympathetic activity. These changes predict worse cardiovascular outcomes in CAD patients, as the ANS compensates for myocardial ischemia and hypoxia by increasing sympathetic drive and reducing vagal activity to preserve cardiac contractility and output. This imbalance triggers a cascade of neurohumoral alterations affecting the cardiovascular, peripheral vascular, and renal systems, further exacerbating disease progression.
Regular exercise is known to play an important role in the prevention, management, and treatment of CAD, mainly through the preservation of endothelial function but also through the improvement of cardiovagal modulation and neurocardiovascular stress reactivity and by the increase in cardiorespiratory fitness. Patients with stable CAD should undergo a cardiac rehabilitation program to fulfill exercise guidelines. Protocols may vary in mode, intensity, frequency, and duration, whereas the most recommended types of exercise are walking and cycling, with intensities between 40-80% of VO2peak associated with increases in exercise capacity by 11-36%. Recent studies demonstrated that high-intensity interval training (HIIT) compared with moderate-intensity continuous training (MICT) promotes higher adaptation in VO2max and in post-exercise heart rate recovery, HIIT has also demonstrated to contribute to the restoration of endothelial function and autonomic balance, inducing reverse cardiac remodeling and increasing left ventricle morphology and function. However, MICT demonstrates higher adherence because it is a safer and more effective approach. Nevertheless, despite the known non-pharmacological benefits of exercise, recent studies demonstrate that more than 15% of the patients with CAD are exercise non-responders to increases in VO2max , i.e., an increase of 3.5 ml/kg/min in VO2max, which has been associated with a 10% decrease in all-cause of mortality and cardiovascular mortality, however the greater the increases in VO2max the greater the reduction in the risk.
Exercise individualization is increasing among apparently healthy populations due to the ease of the use of cellphone applications. Recently, HRV-guided training has been identified as an alternative prescription technique for cardiovascular endurance exercise prescription, this prescription technique demonstrated to contribute to greater improvements in endurance athletes. HRV-guided training concerns to exercise prescribed based on daily changes in HRV, depending on thresholds constructed at the individual level. After an initial characterization period, where the HRV after waking up is measured, the individual HRV profile is defined. Then, considering the resting values of HRV, exercise intensity will be determined for the training session, i.e., if LnRMSSD7day-roll-avg remained inside the smallest worthwhile change (SWC) (+), high-intensity or moderate-intensity training sessions is prescribed, and if LnRMSSD7day-roll-avg fell outside SWC (-), low intensity or rest is prescribed. This prescription technique leads to different workloads from the predefined training programs.
To the best of our knowledge, no study has yet compared the chronic effects of two different exercise protocols on cardiovagal modulation, and cardiorespiratory fitness in patients with CAD. Thus, this research aims to compare the chronic adaptations on cardiorespiratory fitness, cardiovagal modulation, baroreflex sensitivity (BRS), and arterial stiffness (AS) of two different techniques of exercise prescription (traditional vs individualized) and two training methods (HIIT vs MICT) in patients with CAD. We hypothesize that exercise individualization will promote higher adaptations in cardiovagal modulation, cardiorespiratory fitness, BRS and AS in patients with CAD, compared with traditional prescription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •heart failure;
- •cardiac implantable defibrillators;
- •resynchronizing devices;
- •inability to comply with guidelines for participation in exercise testing and training.
研究组 & 干预措施
HRV-Guided Training (training/Behavioral)
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.
干预措施: HRV-Guided Intervention (Other)
HIIT (training/Behavioral)
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.
干预措施: HIIT Intervention (Other)
MICT (training/Behavioral)
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').
干预措施: MICT Intervention (Other)
结局指标
主要结局
Cardiovagal modulation
时间窗: pre and post intervention (12 weeks) assessments
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.
Cardiorespiratory fitness
时间窗: pre and post intervention (12 weeks) assessments
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
次要结局
- 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)
研究者
Manuel Pedro
Principal Investigator (PhD project)
Faculdade de Motricidade Humana
