Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure.

NCT ID: NCT05393362

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2025-07-01

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Sarcopenia; Frail Elderly Syndrome; Comorbidities and Coexisting Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiac Rehabilitation Program (CR)

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Control Group (CG)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise Group; Health education group

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 4.
• Hospitalization in a period of time equal to or less than 3 months.
• Score on the Mini-Mental scale (MMSE) below 24.
• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD.Titular Doctor Physiotherapy Department,University of Malaga.Principal Investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cuesta Vargas A Antonio Ignacio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

Antonio Cuesta Vargas

Málaga, , Spain

Countries

Spain

References

Cuesta-Vargas AI, Fuentes-Abolafio IJ, Garcia-Conejo C, Diaz-Balboa E, Trinidad-Fernandez M, Gutierrez-Sanchez D, Escriche-Escuder A, Cobos-Palacios L, Lopez-Sampalo A, Perez-Ruiz JM, Roldan-Jimenez C, Perez-Velasco MA, Mora-Robles J, Lopez-Carmona MD, Perez-Cruzado D, Martin-Martin J, Perez-Belmonte LM. Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol. BMC Cardiovasc Disord. 2023 Nov 10;23(1):550. doi: 10.1186/s12872-023-03555-7.

Reference Type: DERIVED

PMID: 37950216 (View on PubMed)

Other Identifiers

Funnel+ Study

Identifier Type: -

Identifier Source: org_study_id