Study design
heart failure, dementia, cognitive impairment, angina pectoris
UNCONTROLLED HYPERTENSION, NEUROLOGICAL DISEASE, HEART, INFECTIOUS DISEASE, HEART FAILURE
The present study was a single-blind randomized controlled trial aimed to investigate the effects of a bi-modal non-pharmacological intervention on cognitive parameters and SGS in HD patients. Patients were recruited from a local dialysis center in Ljubljana, Slovenia. The inclusion criteria were as follows: HD kidney replacement therapy (duration > 3 months), stable medical condition, absence of neurological diseases, and the ability to walk independently. The exclusion criteria were: active malignant or infectious disease, uncontrolled hypertension, angina pectoris (2–4 on the Canadian Cardiovascular Society scale), heart failure (3–4 on the New York Heart Association scale), severe cognitive impairment or dementia, history of limb amputation, or any other condition that could cause the patient to be clinically unstable. The study adhered to the ethical principles set forth in the Declaration of Helsinki of 1964 and received approval from the National Medical Ethics Committee (KME0120-474/2021/4). Prior to enrollment, all participants provided written informed consent. The clinical trial was registered with ClinicalTrials.gov (NCT05150444).