Clinical trial NCT04245813: Effectiveness of a Cardiac Rehabilitation Program in Patients With Heart Failure
Official title: Effectiveness of a Cardiac Rehabilitation Program in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Grupo Rehabilitacion en Salud
Sponsor class: NETWORK
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: Universidad de Antioquia
name: Clinica Las Americas
First posted: 2020-01-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Heart failure is a devastating disease with great impact on the quality of life and survival of those who suffer from it. The disease has a high prevalence and its treatment represents high economic costs for health systems. In Colombia, cardiovascular diseases that are part of chronic noncommunicable diseases are the first cause of death. According to figures from the World Health Organization (WHO) in 2014, 28% of deaths in the country were due to cardiovascular diseases.

Pharmacological treatment, patient education and regular physical activity are the cornerstones for the treatment of heart failure and therefore the international clinical practice guidelines as well as the guide of the Colombian Ministry of Health recommend the performance of supervised physical exercise for patients with the disease. Cardiac rehabilitation programs using regular and supervised aerobic exercise positively impact the lives of these patients by improving functional capacity, quality of life, psychological well-being and can have an effect on important outcomes. such as hospitalizations and mortality.

The Health Rehabilitation Group has carried out several research projects on heart failure and other cardiovascular diseases, and in agreement with the Ministry of Health and Social Protection (COLCIENCIAS) developed the Clinical Practice Guide for the Prevention, Diagnosis, Treatment and Rehabilitation of Heart Failure in population over 18 years of age classification B, C and D. The group's research has demonstrated the efficacy and safety of cardiac rehabilitation to improve functional capacity, abdominal perimeter and systemic blood pressure figures in patients with cardiovascular diseases, improvement in the quality of life in patients with heart failure and the prevalence of musculoskeletal diseases has even been described in this group of patients. In one of the studies, an exercise program was compared with an educational program and it was concluded that the exercise was effective in improving the health-related quality of life of patients with heart failure.

Despite the benefits demonstrated by the cardiac rehabilitation programs, the adherence to exercise of the patients is low, especially during phase III of the program in which patients exercise in an unsupervised manner with periodic care follow-up. In some studies they have carried out other types of follow-up such as telephone control, home visits and telemonitoring, but there are no studies that carry out a low-cost program, with telephone follow-up and distance education to improve adherence in the phase III of cardiac rehabilitation.

The aim of this study is to determine the effect of an education, follow-up and stimulus program of adherence to the achievements of phase III of the Rehabilitation Program in patients with heart failure, on functional capacity, quality of life, the need to return to phase II of the program and rehospitalizations.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* Spanish language.
* Live in Medellin or near the city municipalities.
* Available to attend the face-up meetings.
* Accepts to participate in the study.
* Have completed Phase II cardiac rehabilitation.
* Have a confirmed diagnosis of heart failure with ejection fraction measured by echocardiography, scintigraphy or cardiac resonance. For cases with expulsion fraction\> 40%, it is required to have high levels of natriuretic peptides.
* New York Heart Association (NYHA) functional class II and III.

Exclusion Criteria:

* Acute coronary syndrome not treated in the last month.
* Severe symptomatic aortic stenosis.
* Atrial fibrillation with uncontrolled ventricular response.
* Symptomatic or hemodynamic compromise cardiac arrhythmias.
* New York Heart Association (NYHA) functional class IV or that requires the use of parenteral medications such as diuretics or inotropics (in-hospital or outpatient).
* Myocarditis or acute pericarditis.
* Previous aortic dissection.
* Poorly controlled systemic arterial hypertension.
* Recent pulmonary thromboembolism.
* Chronic obstructive pulmonary disease.
* Restrictive lung disease.
* Osteomuscular disease that limits physical activity.
* Cognitive and / or behavioral disorders that prevent the understanding of instructions.
* Difficulty in developing questionnaires in Spanish due to cultural differences.
* Diabetes mellitus decompensated.
* Be participating in another clinical trial.
* Participants who previously did NOT complete the cardiac rehabilitation program.

Primary outcomes:
measure: Adherence to the program in one year (Questionnaire)
timeFrame: One year
Secondary outcomes:
measure: Adherence to the program at 1, 3 and 6 months (Questionnaire)
timeFrame: Months 1, 3 and 6
measure: Functional performance (Stress test with exercise)
timeFrame: Months 1, 3, 6 and 12
measure: Minnesota Living with heart Failure Questionnaire and The Duke Activity Status Index (DASI)
timeFrame: Months 1, 3, 6 and 12
measure: Return to phase II of rehabilitation
timeFrame: Months 1, 3, 6 and 12
measure: Hospitalizations
timeFrame: Months 1, 3, 6 and 12
measure: Death
timeFrame: Months 1, 3, 6 and 12
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Clinica de Las Américas
state: Antioquia
Study officials:
References: