Coronary Artery DiseaseNCT04930939
Heart Rate Variability-guided Training in Cardiac Rehabilitation
A study testing Aerobic training cardiac rehabilitation program in people with Coronary Artery Disease, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aerobic training cardiac rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Heart Rate Variability-guided Training Superior to Predefined Training for Improving Parasympathetic Activity and Aerobic Functional Capacity in Coronary Artery Disease Patients?
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Aerobic training cardiac rehabilitation program
- Keywords
- Cardiorespiratory fitness, Cardiac vagal modulation, Heart rate variability, Cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic training cardiac rehabilitation programOther
Moderate continuous training sessions and high intensity interval training sessiones were used to carried out aerobic training
| Study group | Role | What they receive |
|---|---|---|
| Heart rate variability-guided training group | Experimental | Patients allocated to heart rate variability-guided training group trained 3 days a week for 6 weeks. These patients carried out moderate continuous traininig sessions or high intensity interval training sessions based on their daily heart rate variability assessments follwing a decision schema. Receives: Other: Aerobic training cardiac rehabilitation program |
| Predefined training group | Active comparator | Patients allocated to predefined training group also trained 3 days a week for 6 weeks. Nonetheless, these patients performed a predefined training program regarless of their parasympathetic modulation status. Receives: Other: Aerobic training cardiac rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from PRE in workload at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in absolute oxygen uptake at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in relative oxygen uptake at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in heart rate at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in systolic blood pressure at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in diastolic blood pressure at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in isolated heart rate variability at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in averaged heart rate variability at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), after waking up
Change from PRE in heart rate recovery at 6 weeks (POST)
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.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Secondary outcomes (26)
Change from PRE in body mass index at 6 weeks (POST)
Body mass index (BMI) was calculated according to the formula: total weight in kilograms divided by squared height in meters (kg/m2). All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in total body mass at 6 weeks (POST)
The total body mass of each participant was measured in kilograms using a digital scale (Tanita, TBF 300 A, Tokyo, Japan). All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in breadths at 6 weeks (POST)
The breadths of each participant were measured with a Holtain bicondylar calliper (Holtain, UK). The following four breadths were measured: humerus, wrist, femur, and ankle. All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in girths at 6 weeks (POST)
The total girths of each participant were measured with a metallic non-extensible tape (Lufkin, USA). The following four girths were measured: relaxed arm, flexed and tensed arm, thigh, and medial calf. All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in skinfolds at 6 weeks (POST)
The skinfolds of each participant were measured with a Holtain Tanner/Whitehouse skinfold calliper (Holtain, UK). Eight skinfolds were also measured: triceps, biceps, subscapular, ileocrestal, supraspinale, abdominal, thigh, and medial calf. All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in bone mass at 6 weeks (POST)
The percentage of bone mass of each participant was calculated according to Martin's equation. All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: 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)
The percentage of body fat mass of each participant was calculated using Durnin-Womersley equation. In addition, the sums of the eight skinfolds were considered for fat content calculations. All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in muscle mass at 6 weeks (POST)
The percentage of muscle mass of each participant was calculated from Lee's equation. All anthropometrical variables were measured by a Level 2 anthropometrist certified by the International Society for the Advance of Kinanthropometry (ISAK).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in glucose at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Glucose was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in urea at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Urea was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in creatinine at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Creatinine was measured using standard methods.
Measured: 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)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Uric acid was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in LDH at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. LDH was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in creatine kinase at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Creatine kinase was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in sodium at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Sodium was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in potassium at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Potassium was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in cholesterol at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Cholesterol was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in triglyerides at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Triglycerides were measured using standard methods.
Measured: 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)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. HDL-C was measured using standard methods.
Measured: 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)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. LDL-C was measured using standard methods.
Measured: 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)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Haemoglobin A1c was measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in platelet at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Platelet was measured using standard methods.
Measured: 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)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Red blood cells were measured using standard methods.
Measured: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in haemoglobin at 6 weeks (POST)
Blood samples were obtained from the median cubital vein at PRE and POST after at least a 10-hour fast and 48 h before the test and without performing exercise in that period. Venipuncture took place in the Vinalopó-Salud Hospital of Elche (Spain) and was carried out by a nurse. Haemoglobin was measured using standard methods.
Measured: 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)
The MacNew heart disease health-related quality of life (HRQL) instrument was used as a disease-specific health-related quality of life questionnaire. MacNew has been proved to be a valid and reliable questionnaire applicable to patients with coronary artery disease. The MacNew consists of 27 items that fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). The maximum possible score in any domain is 7 (high HRQL) and the minimum is 1 (poor HRQL).
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in dietary intake at 6 weeks (POST)
Patients recorded food and beverage consumption during 4 consecutive days, including Sunday, before and after the intervention. Data from records were analyzed using the ST-Nutrition software (Servitux, Elche, Spain). Macro- and micronutrient intakes were evaluated paying attention to recommendations performed by the Portfolio dietary pattern for the National Cholesterol Education Program (NECP) Step II.
Measured: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Oct 2018
- Primary completion23 Dec 2018
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment, two groups randomly assigned
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Moya, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930939
- Sponsor's protocol ID
- 2017.165.E.OEP
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Heart Rate Variability-guided Training Superior to Predefined Training for Improving Parasympathetic Activity and Aerobic Functional Capacity in Coronary Artery Disease Patients?
- ClinicalTrials.gov ID
- NCT04930939
- Acronym / sponsor ID
- 2017.165.E.OEP
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiorespiratory fitness, Cardiac vagal modulation, Heart rate variability, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment, two groups randomly assigned
| Arm | Type | Receives |
|---|---|---|
| Heart rate variability-guided training group | Experimental | Other: Aerobic training cardiac rehabilitation programPatients allocated to heart rate variability-guided training group trained 3 days a week for 6 weeks. These patients carried out moderate continuous traininig sessions or high intensity interval training sessions based on their daily heart rate variability assessments follwing a decision schema. |
| Predefined training group | Active comparator | Other: Aerobic training cardiac rehabilitation programPatients allocated to predefined training group also trained 3 days a week for 6 weeks. Nonetheless, these patients performed a predefined training program regarless of their parasympathetic modulation status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Unstable angina
- Atrial fibrillation
- Cardiac implantable electronic devices
- Complex ventricular arrhythmias
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic training cardiac rehabilitation programModerate continuous training sessions and high intensity interval training sessiones were used to carried out aerobic training | Other | Heart rate variability-guided training group, Predefined training group |
Primary outcome
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.
26 secondary outcomes
Change from PRE in body mass index at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in total body mass at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in breadths at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in girths at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in skinfolds at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in bone mass at 6 weeks (POST)
Time frame: 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)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in muscle mass at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in glucose at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in urea at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in creatinine at 6 weeks (POST)
Time frame: 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)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in LDH at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in creatine kinase at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in sodium at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in potassium at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in cholesterol at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in triglyerides at 6 weeks (POST)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in platelet at 6 weeks (POST)
Time frame: 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)
Time frame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
Change from PRE in haemoglobin at 6 weeks (POST)
Time frame: 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)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Change from PRE in dietary intake at 6 weeks (POST)
Time frame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training cardiac rehabilitation program in people with Coronary Artery Disease, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.