Study design: The effects of photobiomodulation therapy combined with exercise training on functional capacity and quality of life in patients with heart failure (double-blind randomized)

Background: Photobiomodulation therapy (PBMT), used to be called low-level laser therapy (LLLT), is a novel therapeutic method in which the red or near-infrared light is used to stimulate healing, relieve pain, and inflammation and prevent tissue from dying. Although in experimental investigations PBMT demonstrated to have many favorable effects on patients with cardiovascular disease, few clinical studies have been conducted in patients with heart failure (HF). Material and Methods: The present study is a single-center, randomized, double-blind, parallel-group controlled trial with placebo which will evaluate the effect of PBMT on functional capacity, quality of life (QOL), echocardiographic parameters, and serum biomarkers of patients with HF-reduced ejection fraction (HFREF) (left ventricular ejection fraction ≤ 40%) who will be referred to cardiac rehabilitation programs. The primary endpoint of the present study is to show the beneficial effect of PBMT on New York Heart Association functional class and the maximum distance walked during 6 min compared to control group. Our secondary endpoint is to show the effects of PBMT on serum pro-brain natriuretic peptide level and QOL. Conclusion: In the present clinical trial, for the 1st time, we will evaluate the effect of LLLT in patients with HFREF. The result of the present trial might introduce a new method for the rehabilitation of these patients.