Effectiveness of a Cardiac Rehabilitation Program in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Effectiveness of a Cardiac Rehabilitation Program in Patients With Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04245813
• Other study ID #: 111580763152
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: May 15, 2023

Study information

• Verified date: October 2022
• Source: Grupo Rehabilitacion en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: May 15, 2023
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Interdisciplinary educational program
Interdisciplinary educational component based on the Clinical Practice Guide for Heart Failure

Locations

Country	Name	City	State
Colombia	Clinica de Las Américas	Medellin	Antioquia

Sponsors (4)

Lead Sponsor	Collaborator
Grupo Rehabilitacion en Salud	Clinica Las Americas, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the program in one year (Questionnaire)	The proportion of adherent patients will be estimated one year after the end of phase II of cardiac rehabilitation in each arm of the study and the relative risk will be calculated with their respective 95% confidence interval.	One year
Secondary	Adherence to the program at 1, 3 and 6 months (Questionnaire)	The proportion of adherent patients will be estimated in each of the periods followed (1, 3 and 6 months) after the end of phase II of cardiac rehabilitation in each arm of the study. The relative risk will be calculated with its respective 95% confidence interval for each of the periods.	Months 1, 3 and 6
Secondary	Functional performance (Stress test with exercise)	Stress test	Months 1, 3, 6 and 12
Secondary	Minnesota Living with heart Failure Questionnaire and The Duke Activity Status Index (DASI)	Minnesota Living with heart Failure Questionnaire and The Duke Activity Status Index (DASI)	Months 1, 3, 6 and 12
Secondary	Return to phase II of rehabilitation	Return to phase II of rehabilitation	Months 1, 3, 6 and 12
Secondary	Hospitalizations	Hospitalizations due to cardiac disease	Months 1, 3, 6 and 12
Secondary	Death	Death of cardiac diseases or other causes	Months 1, 3, 6 and 12