Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05393362
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-05-16
Brief Title:
Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure
Sponsor:
University of Malaga
Organization:
University of Malaga
Study Overview
Official Title:
Effectiveness of a Cardiac Rehabilitation Program on Biomechanical Imaging and Physiological Biomarkers in Elderly Patients With Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUNNEL
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 andor 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
HF is a chronic disease characterized by structural cardiac involvement andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None