This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Heart failure (HF) is a highly prevalent clinical entity that predominantly affects elderly people with comorbidities. Among these, chronic kidney disease is particularly frequent, complicating disease management and worsening prognosis. Supervised training programs in patients with HF have improved functional capacity and reduced hospitalizations. However, the evidence is scarce regarding the effects of a supervised training program on patients with HF and cardiorenal syndrome. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HF and cardiorenal syndrome on peak oxygen consumption (peakVO2). This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training.
Instituto de investigación sanitaria INCLIVA
Valencia, Spain
Peak oxygen consumption
Primary outcome: changes in peak oxygen consumption between groups at 12 weeks. Description: Peak oxigen consumption (also known as maximal functional capacity) will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a semi-supine bicycle ergometer (coupled with stress echocardiography), beginning with a workload of 10 Watts and increasing gradually in a ramp protocol at 10-Watts increments every 1 minute. Peak oxygen consumption (PeakVO2) is defined as the highest value of VO2 during the last 20 seconds of exercise. Unit of measure of peak oxygen consumption: mL/kg/min (this is a directly reported measure from the cardiopulmonary exercise testing, not an aggregated or derived calculation).
Time frame: The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12.
Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy (the patient's understanding of how to manage their heart failure). All Kansas City Cardiomyopathy Questionnaire domains are scaled from 0 to 100, where scores represent health status as follows: 0 to 24, very poor to poor; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to excellent. A change of 5 points is considered to be a small but clinically important change, whereas changes of 10 and 20 points are considered moderate-to-large and large-to-very-large clinical changes.
Time frame: The investigators will evaluate Kansas City Cardiomyopathy Questionnaire at baseline (week 0) and at week 12.
Chronotropic index
Secondary outcome: changes in chronotropic response between groups at 12 weeks. Description: Chronotropic index is an index calculated in a maximal cardiopulmonary exercise testing to assess heart rate response to exercise. The chronotropic index is evaluated by the following formula, including heart rate at peak effort, heart rate at rest and age. Chronotropic index: (peak heart rate-rest heart rate)/ \[220-age-rest heart rate)\]. The chronotropic index has no units of measure.
Time frame: The investigators will evaluate chronotropic index at baseline (week 0) and at week 12.
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