Clinical trial NCT04930939: Heart Rate Variability-guided Training in Cardiac Rehabilitation
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cardiorespiratory fitness
Cardiac vagal modulation
Heart rate variability
Cardiac rehabilitation
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment, two groups randomly assigned
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from PRE in workload at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in absolute oxygen uptake at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in relative oxygen uptake at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in heart rate at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in systolic blood pressure at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in diastolic blood pressure at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in isolated heart rate variability at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in averaged heart rate variability at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), after waking up
measure: Change from PRE in heart rate recovery at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Secondary outcomes:
measure: Change from PRE in body mass index at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in total body mass at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in breadths at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in girths at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in skinfolds at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in bone mass at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in body fat mass at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in muscle mass at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in glucose at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in urea at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in creatinine at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in uric acid at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in LDH at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in creatine kinase at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in sodium at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in potassium at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in cholesterol at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in triglyerides at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in HDL-C at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in LDL-C at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in haemoglobin A1c at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in platelet at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in red blood cells at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in haemoglobin at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM
measure: Change from PRE in quality of life at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
measure: Change from PRE in dietary intake at 6 weeks (POST)
timeFrame: Baseline (PRE) and at 6 weeks (POST), at the same period of the day
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernández
state: Alicante
Study officials:
References: