Is Heart Rate Variability-guided Training Superior to Predefined Training for Improving Parasympathetic Activity and Aerobic Functional Capacity in Coronary Artery Disease Patients?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Universidad Miguel Hernandez de Elche
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change from PRE in workload at 6 weeks (POST)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Background: Previous studies have reported that heart rate variability (HRV)-guided training is a better option for improving autonomic function and aerobic capacity (i.e., oxygen uptake and power output at second ventilatory threshold and maximal exercise) during a cardiopulmonary exercise test compared to predefined training in sedentary and physically active healthy people. Nevertheless, none of these previous studies have been carried out with coronary artery disease (CAD) patients.
Methods: A total of 23 patients with CAD were divided into HRV-guided training group (HRV-G; n = 11) and predefined training group (PRE-G; n = 12). All patients trained three days a week for eight weeks (18 sessions). Patients allocated in the PRED-G carried out a previously established cardiac rehabilitation programme, combining sessions of moderate and high intensity, while patients allocated in the HRV-G carried out sessions of moderate or high intensity on the basis of their daily HRV assessments. The weekly averaged and isolated parasympathetic-related HRV indices, heart rate recovery, resting heart rate, and aerobic capacity were assessed before and after of the training programme.
Detailed Description
This study was a parallel-group, double-blind, randomised controlled trial. This study was approved by the ethical committee of the local University and was conducted conforming to the recommendations of the Declaration of Helsinki. Eligible patients were men and women with low-risk and age ≥ 18 years, who had experienced an acute myocardial infarction, angina pectoris, had undergone revascularisation (percutaneous transluminal coronary angioplasty or coronary artery bypass grafting) or coronary heart disease was documented by angiography, up to one year before to the enrolment in the study. Exclusion criteria included unstable angina, atrial fibrillation, cardiac implantable electronic devices, complex ventricular arrhythmias, uncontrolled hypertension, conditions limiting participation in exercise training and/or symptom-limited cardiopulmonary exercise test at pre-intervention. Before taking part in the study, patients were interviewed and signed a written informed consent. The patients were randomly allocated to a predefined training group (PRED-G; n = 12) or heart rate variability (HRV)-guided training group (HRV-G; n = 11).Before to start the study protocol, patients were instructed to properly carry out day-to-day HRV measurements. The study protocol was divided into two periods: a 2-week baseline period (BP) and a 6-week training period (TP). Before and after TP, baseline assessment week (PRE) and final assessment week (POST) were conducted, respectively. The variables/tests assessed/included in the assessment weeks were: cardiopulmonary exercise test, autonomic function, body composition, blood analysis, quality of life and dietary intake. Assessments were carried out in the same sequence and at the same period of the day. Patients and assessors recording the outcome measurements were blinded to the group allocations. Throughout the 6-week TP, patients allocated to PRED-G carried out a predefined training program, while patients that were assigned to HRV-G trained based on day-to-day HRV measurements.
Investigators
Manuel Moya
Principal investigator
Universidad Miguel Hernandez de Elche
Eligibility Criteria
Inclusion Criteria
- •Patients who had experienced an acute myocardial infarction up to one year before to the enrolment in the study
- •Patients who had experienced an angina pectoris up to one year before to the enrolment in the study
- •Patients who had undergone revascularisation (percutaneous transluminal coronary angioplasty or coronary artery bypass grafting), up to one year before to the enrolment in the study
- •Clinical diagnosis of coronary heart disease documented by angiography, up to one year before to the enrolment in the study
Exclusion Criteria
- •Unstable angina
- •Atrial fibrillation
- •Cardiac implantable electronic devices
- •Complex ventricular arrhythmias
- •Uncontrolled hypertension
- •Conditions limiting participation in exercise training
- •Symptom-limited cardiopulmonary exercise test at PRE
Outcomes
Primary Outcomes
Change from PRE in workload at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). The workload was obtained in Watts at the exercise peak and second ventilatory threshold. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Change from PRE in absolute oxygen uptake at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). Respiratory gas exchange was measured by MasterScreen CPX (Jaeger, Hoechberg, Germany). The oxygen uptake (VO2), expressed in absolute values (mL/min), was obtained at exercise peak, second ventilatory threshold and in resting condition. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Change from PRE in relative oxygen uptake at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). Respiratory gas exchange was measured by MasterScreen CPX (Jaeger, Hoechberg, Germany). The oxygen uptake (VO2), expressed in relative values to each individual's body weight (mL/kg/min), was obtained at exercise peak, second ventilatory threshold and in resting condition. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Change from PRE in heart rate at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). The heart rate (HR) was monitored continuously using a 12-lead electrocardiogram (Jaeger, Hoechberg, Germany). The HR was measured in beats per minute at exercise peak, second ventilatory threshold and in resting condition. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Change from PRE in systolic blood pressure at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). A digital sphygmomanometer (Tango+, Suntech, USA) was used for the assessment of systolic blood pressure. The systolic blood pressure was measured in millimetres of mercury at the exercise peak and in resting condition. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Change from PRE in diastolic blood pressure at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). A digital sphygmomanometer (Tango+, Suntech, USA) was used for the assessment of diastolic blood pressure. The diastolic blood pressure was measured in millimetres of mercury at the exercise peak and in resting condition. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Change from PRE in isolated heart rate variability at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Isolated heart rate variability (HRV) assessments were performed in a quiet room with an average temperature of 22ᵒC. Polar H7 chest strap (Polar Electro OY, Kempele, Finland) and Elite HRV app (Perrotta, Jeklin, Hives, Meanwell, \& Warburton, 2017) were used to capture HRV measurements. Patients were informed to avoid talking and sleeping, controlling breathing pace to 12 breaths per min. The length of the recording was 20 min, and the last 5 min was selected to calculate HRV indexes. Kubios HRV Software 2.0 for Windows (The Biomedical Signal Analysis Group, Kuopio, Finland) was used to analyse time and frequency domain indices in absolute and normalised units.
Change from PRE in averaged heart rate variability at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), after waking up
All patients were instructed to assess their heart rate variability (HRV) in the morning at home every day throughout the entire study. The HRV recordings were attained via a photoplethysmography smartphone application (HRV4Ttraining) previously validated (Daniel J Plews et al., 2017). HRV assess were done at rest, as patients lay supine for 90 s with spontaneous breathing in a semi-dark room, and the las 60 s were capture. Day-to-day HRV values across assessment weeks (PRE and POST) were averaged to obtain a 7-day weekly averaged HRV value.
Change from PRE in heart rate recovery at 6 weeks (POST)
Time Frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
A cardiopulmonary exercise test was performed using a medically supervised maximal graded cycle ergometer exercise test (Excite Bike Med, Technogym, Cesana, Italy) at the Miguel Hernandez University of Elche (Spain). The heart rate (HR) was monitored continuously using a 12-lead electrocardiogram (Jaeger, Hoechberg, Germany). After the exercise peak, a 3-min cool-down at 10 W was performed. The reduction in HR from immediately exercise peak to the HR after 1 and 2 min was defined as HR recovery (HRR) 1 min and HRR 2 min, respectively. An experienced exercise physiologist together with a cardiologist supervised all the cardiorespiratory tests.
Secondary Outcomes
- Change from PRE in body mass index at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in girths at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in sodium at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in LDH at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in HDL-C at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in total body mass at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in breadths at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in skinfolds at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in bone mass at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in body fat mass at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in muscle mass at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in glucose at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in urea at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in creatinine at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in uric acid at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in potassium at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in quality of life at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in creatine kinase at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in cholesterol at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in triglyerides at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in LDL-C at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in haemoglobin A1c at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in red blood cells at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in haemoglobin at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)
- Change from PRE in dietary intake at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), at the same period of the day)
- Change from PRE in platelet at 6 weeks (POST)(Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM)