Improvement of Physical Activity with Acupuncture and Kinesitherapy Versus Kinesitherapy Alone in Patients with Acute Decompensated Chronic Heart Failure with Reduced Ejection Fraction Treated with Optimal Drug Therapy, a Randomized, Sham-Procedure-Controlled, Double-Blind Clinical Study

Background: /Objectives: It is unknown how early exercise therapy combined with acupuncture (AP) affects the speed of recovery in patients with heart failure with reduced ejection fraction (HFrEF) who are hospitalized due to worsening HF. Methods: A prospective, sham-procedure-controlled, double-blind, randomized clinical trial with three patient groups was conducted. The study included patients with HFrEF who were hospitalized for worsening HF. After initial stabilization, patients were randomly assigned to three groups, the controls (C) treated with optimal drug therapy (ODT); E1 received ODT with kinesitherapy, and sham AP; E2 received ODT, kinesitherapy, and needle AP aiming to enhance compensation. Improvement in physical activity was measured by the modified Barthel index (A test), 2- or 6-minute, and endurance walking tests, and decrease of blood brain natriuretic peptide (BNP). Results: The 120 patients completed the study. The average age was 74 years, males 73.3%, median EF 32%, NYHA III had 83.3%. After the 5th day of therapy, the E2 group showed the greatest improvement in the A test compared to other groups (p=0.022). After 5 days, 80%, 50% and 10% achieved A test score of 30 or higher, demonstrating functional independence (p<0.01) in E2, E1 and C group, respectively. At hospital discharge, the E2 group showed significantly better walking endurance compared to the E1 and C groups (p<0.001). At discharge, BNP significantly decreased in both E groups. Conclusions: Short-term early rehabilitation with AP and kinesitherapy significantly improves the functional status of HFrEF decompensated patients when compared to kinesitherapy alone and ODT.