FUNNEL+: Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure.
Study Details
Study Description
Brief Summary
The main objective of the study is to assess the effectiveness of a cardiac rehabilitation program on functionality, measured by kinematic analysis, cardiorespiratory capacity, and ventricular ejection fraction in elderly patients with heart failure (HF). Other objectives will be; 1) to validate the kinematic analysis as an objective functional assessment that allows performing a functional stratification based on the severity of impairment ("kinematic phenotypes"), as well as to identify those patients who responders or are not responders to the cardiac rehabilitation program; 2) to develop a functional index that includes objective functional parameters, kinematic biomarkers (heart and musculoskeletal echography) and physiological biomarkers (maximum consumption of oxygen (VO2 max), maximum heart rate (HR max) and blood lactate levels; 3) to analyse the degree of concordance of kinematics biomarkers with functional tests normally used in clinical practice and with structural and physiological biomarkers. A randomized, controlled, crossover clinical trial will be carried out at the Hospital Regional Universitario de Málaga. Clinically stable HF patients ≥70 years old will be included. The cardiac rehabilitation program will last 12 weeks and will follow the recommendations of the European Association of Cardiovascular Prevention and Rehabilitation. The patients will perform different functional tests, which will be at baseline, at 3 months and 6 months of follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Cardiovascular diseases continue to be the main cause of years of life disability-adjusted disability and the leading cause of death, especially in countries with longer life expectancy. Within cardiovascular diseases, Heart Failure (HF) represents a health problem of the first order, with figures of incidence and increasing prevalence associated with the progressive aging of the population and the significant advances in the treatment of chronic diseases associated with HF. HR reaches high morbidity and mortality and is one of the most common reasons for hospital admission common in elderly people, among whom frailty and sarcopenia are commonly associated. All this means that HF has a great impact both at the care level, personal as well as social and economic for public health systems.
HF is a chronic disease characterized by structural cardiac involvement and/or the function that leads to a decrease in cardiac output, which leads to an inability to satisfy the metabolic demands of the organism. Under this circumstance, they end up producing alterations that lead to dyspnea and fatigue, among other manifestations, which functionally limit patients. These patients have a number of characteristics. Distinctive functional characteristics such as reduced aerobic capacity, decreased speed of gait, decreased muscle strength predominantly in the lower limbs, low physical activity, and intolerance to exercise, so they affect the performance of their activities of daily life and their quality of life. These alterations have been associated independently with survival and risk of admission in patients with HF.
In the assessment of physiological biomarkers or cardiovascular functional parameters, maximal oxygen uptake (Peak VO₂) obtained from a cardiopulmonary exercise test (CPET) was considered the reference test to determine cardiovascular functional capacity, exercise tolerance, and prognosis in patients with HF. Various tests have been used useful for the indirect assessment of functionality and prognosis in patients with HR. Among them is the 6-minute walk test (6-MWT), the short battery of physical performance (SPPB), and the Timed Up and Go (TUG) test to evaluate capacity cardiopulmonary and frailty in patients with HF.
Cardiac rehabilitation (CR) is a multidimensional treatment designed to promote changes in lifestyle and physical activity, optimize medical treatment, control risk factors, and address post-developmental social and psychological issues of heart disease. These CR programs have a strong recommendation (Class I) by the guidelines of the European Society of Cardiology (ESC), the American Association of Heart Association (AHA), and the American College of Cardiology (ACC) in the treatment of patients with chronic HF. In addition, it is a cost-effective intervention in HF, since it improves the prognosis by reducing recurrent hospitalizations and health spending, while it has been associated with an increase in survival. They have also shown benefits in the control of cardiovascular risk factors, in anthropometric variables, in blood, physiological (Peak VO₂), and cardiac structural biomarkers such as ejection fraction ventricular.
However, kinematic biomarkers, as an objective measure of the functionality of these patients and, therefore, the benefits of the cardiac rehabilitation programs on these kinematic biomarkers. These biomarkers could make it possible to quantify normal and pathological movements, the degree of deterioration, plan rehabilitation strategies and evaluate the effect of various interventions. Therefore, they could be useful to identify objective parameter functions that could be affected in patients with HF, help to stratify patients with HF based on different levels of functional impairment, in addition, to identify those responders and non-responders to CR programs. To do this, the sensors inertial sensors have been shown to be a precise and reliable method for kinematic evaluation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cardiac Rehabilitation Program (CR) The CR program will consist of aerobic exercise sessions and strength exercise sessions. The exercises will be individualized after assessing short effort capacities (strength exercise) and long efforts (aerobic exercise). It will be done four days a week, with a minimum of 48 hours between sessions of the same type of exercise. To make progress will be taking a clinical criterion into account, determined by the absence of symptoms derived from HF at the current intensity, and a temporary criterion where provided that the clinical criterion is met, the intensity will be increased every two-three weeks. |
Procedure: Cardiac Rehabilitation Program (CR)
Strength exercises: strengthe exercise will be performed twice a week for 12 weeks, 4-6 series at 60% RM at the beginning of the program, with a progression towards 85% RM in each functional movement at the end of the intervention. The patients will rest for 90 seconds between series and 3 minutes between exercises. Each session has an estimated duration of between 45-60 min.
Aerobic exercise: aerobic exercise it will be performed twice a week for twelve weeks, between 45-60 min each session of aerobic exercise. It will be developed on a treadmill or cycle ergometer at 50% of HR max at the beginning of the program with a progression towards 80% of HR max at the end, continuously or internally. The Borg scale will prevail over the objective data to adjust the intensity of each patient, Borg = 10/20 or mBorg = 5/10 at the beginning, with progression to Borg = 14/20 or mBorg = 8/10 at the end.
Other Names:
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| Active Comparator: Control Group (CG) The control group will receive two education sessions per week for twelve weeks on the complications derived from Heart Failure (HF), functional deterioration, and healthy lifestyle habits. |
Behavioral: Control Group (CG)
The control group will receive two education sessions per week for twelve weeks on the complications derived from Heart Failure (HF), functional deterioration, and healthy lifestyle habits.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) [Baseline]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake [VO2,(ml/kg/min)]
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) [Post intervention_difference (12 weeks after baseline)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake [VO2,(ml/kg/min)]
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) [Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake [VO2,(ml/kg/min)]
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (R) [Baseline]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Respiratory coefficient or respiratory exchange ratio [R], is defined as the ratio between CO2 production and O2 consumption (VCO2/VO2).
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (R) [Post intervention_difference (12 weeks after baseline)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Respiratory coefficient or respiratory exchange ratio [R], is defined as the ratio between CO2 production and O2 consumption (VCO2/VO2).
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (R) [Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Respiratory coefficient or respiratory exchange ratio [R], is defined as the ratio between CO2 production and O2 consumption (VCO2/VO2).
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE) [Baseline]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Pulmonary Ventilation, the volume of air moved in and out of the lung [VE,(L/min)]
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE) [Post intervention_difference (12 weeks after baseline)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Pulmonary Ventilation, the volume of air moved in and out of the lung [VE,(L/min)]
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE) [Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Pulmonary Ventilation, the volume of air moved in and out of the lung [VE,(L/min)]
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/VO2) [Baseline]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory equivalents for oxygen [VE/VO2], the ratios between pulmonary ventilation and O2 consumption (VE/VO2)
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/VO2) [Post intervention_difference (12 weeks after baseline)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory equivalents for oxygen [VE/VO2], the ratios between pulmonary ventilation and O2 consumption (VE/VO2)
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/VO2) [Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory equivalents for oxygen [VE/VO2], the ratios between pulmonary ventilation and O2 consumption (VE/VO2)
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/VCO2) [Baseline]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory equivalents for oxygen [VE/VO2], the ratios between pulmonary ventilation and CO2 production(VE/VCO2)
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/VCO2) [Post intervention_difference (12 weeks after baseline)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory equivalents for oxygen [VE/VO2], the ratios between pulmonary ventilation and CO2 production(VE/VCO2)
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/VCO2) [Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory equivalents for oxygen [VE/VO2], the ratios between pulmonary ventilation and CO2 production(VE/VCO2)
Secondary Outcome Measures
- Metabolic biomarkers_Blood lactate [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Lactate Pro 2 Blood Lactate Analyzer Measure. Blood lactate (mmol/L)
- Structural biomarkers_Cardiac-Echocardiogram (LVEF) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Echocardiogram Measure:Left ventricular Ejection Fraction (%), LVEF
- Structural biomarkers_Cardiac-Echocardiogram (Dilatation and Diameter of the left atrium and left ventricle) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Echocardiogram Measure: Dilatation of the left atrium, Dilatation of the left ventricle, Diameter of the left atrium, Diameter of the left ventricle (cm)
- Structural biomarkers_Muscular-Echocardiographic (Muscle Thickness) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan) Measure: Muscular thickness of the quadriceps rectus muscle through Matlab software (CodigoEco)-[Muscle Thickness]
- Structural biomarkers_Muscular-Echocardiographic (Muscle Echo-Intensity) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan) Measure: Muscle Echo-intensity of the quadriceps rectus muscle through Matlab software (CodigoEco)- [Muscle His]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_hemoglobin [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: hemoglobin 1AC, blood (%)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_hematocrit [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: hematocrit (%)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Mean Corpuscular Volume (MCV) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: mean corpuscular volume [MCV,(fL)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Mean Corpuscular Hemoglobin (MCH) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: mean corpuscular hemoglobin [MCH,(pg)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Mean Corpuscular Hemoglobin Concentration (MCHC) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: mean corpuscular hemoglobin [MCHC,(g/dL)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Leukocytes [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: leukocytes (mg/dL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Platelet count [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: platelet count (units/mcL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Glucose [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: glucose (mmol/L)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Creatinine [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: creatinine (mg/dL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Glomerular Filtration Rate (GFR) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: glomerular filtration rate [GFR, (mL/min/1.73m²)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Uric Acid [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: uric acid (mg/dL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_sodium, potassium, calcium [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: sodium, potassium, and calcium (mmol/L)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_transaminases -ALT, AST, GGT, FA [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure:transaminases Aminotransferase, alanine [ALT, (U/L)] Aminotransferase, aspartate [AST,(U/L)] Gamma-glutamyl transpeptidase [GGT,(U/L)] Alpha fetoprotein[FA,(mcg/L)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_glycated hemoglobin [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: glycated hemoglobin (mmol/mol)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ferritin [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: ferritin (ng/mL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_iron [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: iron (mcg/dL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_Index of transferrin saturation [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: index of transferrin saturation (%)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_transferrin [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: transferrin (mg/dL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ vitamin B12 [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: vitamin B12 (pg/mL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ folic acid [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: folic acid (ng/mL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ TSH [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: TSH (mclU/mL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ Total cholesterol (TC) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: total cholesterol [TC,(mg/dL)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ LDL [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: Low-density lipoprotein [LDL,(mg/dL)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ HDL [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: High-density lipoprotein [HDL,(mg/dL)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ triglycerides [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: triglycerides (mg/dL9
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ albumin [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: albumin (g/dL)
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ NT-proBNP [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure:N-Terminal propeptide of BNP[NT-proBNP,(pg/mL)]
- Blood biomarkers_ Complete Blood Cell Count (CBC)_ vitamin D. [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: The blood test. The extraction of the blood sample must be carried out by a qualified professional (Physician or Nurse). For data analysis, the samples will be sent to the laboratory to recounter de sample. Measure: vitamin D (ng/ml)
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(PETCO2) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: End-tidal CO2 partial pressure [PETCO2, (mmHg)]
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (O2 pulse) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Oxygen pulse [O2 pulse] is the ratio between VO2 (mLO2/min) and heart rate (HR - bpm).
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (VE/MVV) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Breathing reserve [VE/MVV] represents the ratio between maximal ventilation during exercise (VE) and maximum voluntary ventilation (MVV) at rest, both variables in L/min.
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(ΔVO2/ΔWR) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: [ΔVO2/ΔWR] Relationship. It is defined as the relationship between VO2 (Y-axis in mL.min-1) and workload (X-axis in Watts), measured only during exercise on a cycle ergometer with ramp protocol, whose value is progressively and linearly incremented until maximal effort.
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(Peak HR) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Peak of Heart Rate [Peak HR,(bpm)].
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(RER) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: The respiratory exchange ratio [RER] is the ratio of VCO2/VO2
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(VAT) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: Ventilatory Anaerobic Threshold [VAT]
- Kinematic biomarkers _ RGB-D camera (depth camera)_Trunk linear acceleration [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: RGB-D camera or depth camera. Kinematic analysis by 3D motion capture. Measure: Trunk linear acceleration (m/s2)
- Kinematic biomarkers _ RGB-D camera (depth camera)_Trunk angular displacement [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: RGB-D camera or depth camera. Kinematic analysis by 3D motion capture. Measure: Trunk angular displacement (°)
- Kinematic biomarkers _ RGB-D camera (depth camera)_Trunk angular velocity [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: RGB-D camera or depth camera. Kinematic analysis by 3D motion capture. Measure: Trunk angular velocity (°/s)
- Kinematic biomarkers _ Shimmer3_Step and stride length [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Step and stride length
- Kinematic biomarkers _ Shimmer3_Step and stride widths stride [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Step and stride widths stride
- Kinematic biomarkers _ Shimmer3_Step and stride time [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Step and stride time (seg)
- Kinematic biomarkers _ Shimmer3_Stance phase [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Stance phase
- Kinematic biomarkers _ Shimmer3_Swing phase time gait [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Swing phase time gait
- Kinematic biomarkers _ Shimmer3_Gait speed (m/s) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Gait speed (m/s)
- Kinematic biomarkers _ Shimmer3_Step symmetry [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Step symmetry
- Kinematic biomarkers _ Shimmer3_Step speed and stride. [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Inertial sensor (Accelerometer, Gyroscope, and Magnetometer) included in the Shimmer3 instrument. Measure: Step speed and stride.
- Funtional test _ Timed Up and Go (TUG) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: a long corridor, a chair, a cone and a chronometer Measure: Time (seg) it takes to get up from a chair, walk 3 meters, turn around, return to the chair and sit down again.
- Funtional test _ Six minute walk test (6-MWT) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: a long corridor and a chronometer Measure: Evaluate the distance (m) a participant can walk for 6 minutes.
- Funtional test _ Short Physical performance Battery (SPPB) [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: a long corridor, a chair, and a chronometer Measure: A set of short tests that time the time it takes to cover a short distance (4 m), repeat 5 times sit-stand up from the chair, and a set of balance tests (feet together, semi-tandem, and tandem). The end result is a score.
- Self-reported_ Borg Rating of Perceived Exertion (RPE)-Borg Scale [Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)]
Instruments: Borg Rating of Perceived Exertion (RPE)- Borg Scale Measure: The Borg Rating of Perceived Exertion (RPE) is a way of measuring physical activity intensity level. Perceived exertion is how hard you feel like your body is working. It is based on the physical sensations a person experiences during physical activity, including increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. Although this is a subjective measure, your exertion rating based on a 6 to 20 rating scale, may provide a fairly good estimate of your actual heart rate during physical activity
Other Outcome Measures
- Sociodemographic variables [Baseline]
Instruments: questionnaire, interview. Measure: Age Gender Civil Status Educational Level
- Anthropometric variables_ Height [Baseline]
Instruments: Weighing machine, measuring tape, calculator Measure: height (cm)
- Anthropometric variables_ Weight [Baseline]
Instruments: Weighing machine, measuring tape, calculator Measure: Weight (Kg)
- Anthropometric variables_Body Mass Index (BMI). [Baseline]
Instruments: Weighing machine, measuring tape, calculator Measure: body mass index (BMI).
- Clinical Variables_Comorbidities [Baseline]
Measure: Comorbidities, specifying number and types Instruments: Comorbidity Index of Charlson
- Clinical Variables_Medication [Baseline]
Measure: Medication (specifying number of drugs and types),
- Clinical Variables_ Characteristics of the heart failure (HF)_NYHA [Baseline]
Measure: Characteristics of the heart failure (HF) -main cause (ischemic/non-ischemic) Instruments: Grade of the New York Heart Association (NYHA) and symptom score from the Kansas-City questionnaire
- Clinical Variables_ Characteristics of the heart failure (HF)_Kansas-City Questionnaire [Baseline]
Measure: Characteristics of the heart failure (HF) -main cause (ischemic/non-ischemic) Instruments: symptom score from the Kansas-City questionnaire
- Clinical Variables_Hospitalizations in the last 12 months [Baseline]
Measure: Hospitalizations in the last 12 months (number and reason: any cause/HF decompensated),
- Clinical Variables_Consultation in the emergency department in the last 12 months [Baseline]
Measure: Consultation in the emergency department in the last 12 months (number and reason: any cause/decompensated HF)
- Clinical Variables_Number of falls in the last 12 months [Baseline]
Measure: Number of falls in the last 12 months
- Clinical Variables_Toxic habits [Baseline]
Measure: toxic habits (tobacco, alcohol...).
- Self-reported_Sarcopenia Questionnaire (SARC-F) [Baseline]
Instruments: SARC-F questionnaire Measure: It is a simple questionnaire to rapidly diagnose Sarcopenia. It is composed by 5 components: Strength, Assistance to walk, Get up from a chair, Climb stairs and Falls. Scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 could predict sarcopenia and poor results.
- Self-reported_abbreviated Comprehensive Geriatric Assessment (aCGA): [Baseline]
Instruments: abbreviated Comprehensive Geriatric Assessment (aCGA): a questionnaire formed by items originating from four different scales. Measure: 4 instruments such as: the Geriatric Depression Scale (GDS), the Mini-Mental State Examination (MMSE), Activities of Daily Living (ADL) using the Katz index and instrumental activities of daily living (IADL) using the Lawnton & Brody scale. The score varies from 0 to 30 points, giving 1 point to each of the items of the GDS (4 points in total), 12 to the 3 items from the scale of Lawton & Brody, 8 points to the 4 items from the MMSE and 6 points to the 3 items from the Katz index.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects older than 70 years.
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Subjects diagnosed with Heart Failure (HF) followed by the Heart Failure Unit.
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Subjects will be able or filling out questionnaires and perform functional tasks;
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Clinical stability.
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Patients receive optimal treatment.
Exclusion Criteria:
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Participants with cardiac pathologies that do not have an HF situation
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Score on the NYHA scale equal to 4.
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Hospitalization in a period of time equal to or less than 3 months.
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Score on the Mini-Mental scale (MMSE) below 24.
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Inability to get up from the chair at least 5 times
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Inability to walk.
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Inability to walk independently without a gait assist device (cane, crutch, or walker).
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Participation in an experimental study where they receive treatment.
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Inability to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Antonio Cuesta Vargas | Málaga | Spain |
Sponsors and Collaborators
- University of Malaga
Investigators
- Principal Investigator: Cuesta Vargas A Antonio Ignacio, PhD, University of Malaga
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Funnel+ Study