Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 22?C. 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 |
|
| Primary |
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 |
|
| Primary |
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 |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), between 8:00 AM and 9:00 AM |
|
| Secondary |
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). |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
|
| Secondary |
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. |
Baseline (PRE) and at 6 weeks (POST), at the same period of the day |
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