Heart Rate Variability-guided Training in Cardiac Rehabilitation

NCT04930939 | Completed

• 1 other identifier: 2017.165.E.OEP
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Cardiorespiratory fitness; Cardiac vagal modulation; Heart rate variability; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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)

  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 girths 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

Study Arms (2)

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.

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.

Other: Aerobic training cardiac rehabilitation program

Interventions

Aerobic training cardiac rehabilitation program OTHER

Moderate continuous training sessions and high intensity interval training sessiones were used to carried out aerobic training

Heart rate variability-guided training group; Predefined training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Universidad Miguel Hernández

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and assessors recoding the outcome measurements were blinded to the group allocations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel assignment, two groups randomly assigned

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 18, 2021
• Study Start: October 1, 2018
• Primary Completion: December 23, 2018
• Study Completion: July 30, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

ES (1)