Effectiveness of a Cardiac Rehabilitation Program on Biomechanical, Imaging, and Physiological Biomarkers in Elderly Patients With Heart Failure.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- University of Malaga
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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, biomechanical 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 biomechanical biomarkers with functional tests normally used in clinical practice and with imaging 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.
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 imaging biomarkers such as ejection fraction ventricular. However, biomechanical biomarkers, as an objective measure of the functionality of these patients and, therefore, the benefits of the cardiac rehabilitation programs on these biomechanical 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.
Investigators
Dr. Antonio I Cuesta-Vargas
PhD.Titular Doctor Physiotherapy Department,University of Malaga.Principal Investigator.
University of Malaga
Eligibility Criteria
Inclusion Criteria
- •Subjects older than 70 years.
- •Subjects diagnosed with Heart Failure (HF) followed by the Heart Failure Unit.
- •Subjects will be able or filling out questionnaires and perform functional tasks;
- •Clinical stability.
- •Patients receive optimal treatment.
Exclusion Criteria
- •Participants with cardiac pathologies that do not have an HF situation
- •Score on the NYHA scale equal to
- •Hospitalization in a period of time equal to or less than 3 months.
- •Score on the Mini-Mental scale (MMSE) below
- •Inability to get up from the chair at least 5 times
- •Inability to walk.
- •Inability to walk independently without a gait assist device (cane, crutch, or walker).
- •Participation in an experimental study where they receive treatment.
- •Inability to provide informed consent.
Outcomes
Primary Outcomes
Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)
Time Frame: Follow up (12 weeks after post-intervention)
Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \[VO2,(ml/kg/min)\]
Secondary Outcomes
- Physiological biomarkers _Spirometric assessment-(TV)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(FVC)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(MIP)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (TBW)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (PhA)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (R)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (Xc)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (FM)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (ECW)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(VC)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(FEV1)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment- (F-Iso-FD-S)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(VO2-VT1)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (FFM)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(IRV)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(ERV)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(MEP)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment-Timed Up and Go (TUG)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment-Six minute walk test (6-MWT)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Metabolic biomarkers_Blood lactate(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(Peak HR)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(RER)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(PeakW)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (BCM)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (ECW/TBW)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(IC)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Spirometric assessment-(PEF)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment-Short Physical performance Battery (SPPB)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)- (OUES)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(Vd/Vt)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(VE/MVV)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(PETO2)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(VE/VCO2)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(ΔVO2/ΔWR)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(PETCO2)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_hematocrit(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_Leukocytes(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_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))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_transferrin(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ vitamin B12(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment-(MDR-Hd-sEMG)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment-(VC-Hd-sEMG)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Dynamometric assesment- (F-Iso-FD-din)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(HRR)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(VO2/HR,O2 pulse)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(CRE)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_Platelet count(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(PeakVE)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_hemoglobin(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_iron(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ TSH(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ LDL(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Cardiopulmonary Exercise Testing (CPET)-(VE/VO2)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_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))
- Physiological biomarkers_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))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_Creatinine(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_Glucose(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_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))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ferritin(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers_ Shimmer3_Step and stride time(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ albumin(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_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))
- Physiological biomarkers_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))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_Uric Acid(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ folic acid(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers_ RGB-D camera (depth camera)_Trunk angular displacement(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ Shimmer3_Stance phase(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Imaging 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))
- Physiological biomarkers_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))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_glycated hemoglobin(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_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))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ triglycerides(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ Shimmer3_Gait speed (m/s)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ HDL(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ vitamin D.(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ RGB-D camera (depth camera)_Trunk linear acceleration(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Imaging biomarkers _Cardiac-Echocardiogram (LVEF)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Imaging biomarkers_Muscular-Echocardiographic (Muscle Echo-Intensity)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers_Blood biomarkers_ Complete Blood Cell Count (CBC)_ NT-proBNP(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ RGB-D camera (depth camera)_Trunk angular velocity(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ Shimmer3_Step and stride widths stride(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ Shimmer3_Swing phase time gait(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ Shimmer3_Step speed and stride.(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Biomechanical biomarkers _ Shimmer3_Step symmetry(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Imaging biomarkers _Muscular-Echocardiographic (Muscle Thickness)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- 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))
- Biomechanical biomarkers_ Shimmer3_Step and stride length(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Imaging biomarkers _Displacement-Echocardiographic (Slide-pL)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Imaging biomarkers_Muscular-Echocardiographic (Fat Thickness)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Self-reported_abbreviated Comprehensive Geriatric Assessment (aCGA):(Baseline, Post-intervention (12 weeks after baseline))
- Imaging biomarkers_Muscular-Echocardiographic (Fat Echo-Intensity)(Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Self-reported_Sarcopenia Questionnaire (SARC-F)(Baseline, Post-intervention (12 weeks after baseline))