Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04930939
Study type Interventional
Source Universidad Miguel Hernandez de Elche
Contact
Status Completed
Phase N/A
Start date October 1, 2018
Completion date July 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A