The Efficacy and Safety of Phase I Cardiac Rehabilitation in Patients Hospitalized in Cardiac Intensive Care Unit With Acute Decompensated Heart Failure: A Study Protocol for a Randomized, Controlled, Clinical Trial.

Linjing Wu,Zaixing Shi,Hongfei Jiang,Cuilian Dai,Mengmeng Xue,Linjian Chen,Fanqi Meng,Peng Zhang,Yamin Zheng,Jiahua Li

doi:10.3389/fcvm.2022.788503

Abstract

BackgroundCardiac rehabilitation (CR) improves outcomes in patients with heart failure. However, data on CR efficacy in patients with acute decompensated heart failure is limited. This study is designed to assess the efficacy and safety of CR in patients hospitalized in cardiac intensive care unit (CICU) with acute decompensated heart failure (ADHF).MethodsThis is a single-center, randomized controlled, single-blind clinical trial. A total of 120 participants hospitalized in CICU with ADHF will be randomly allocated in the ratio of 1:1 to two groups: CR group and control group. Participants will receive tailored and progressive CR intervention or attention control. The CR intervention include personalized breathing training, small muscle group resistance training, and aerobic endurance training based on the physical fitness assessment results. The subjects will receive the CR training for 5 days and will be followed up for 6 months. The primary endpoints are the score of the short physical performance battery (SPPB) and 6-month all-cause rehospitalization. The secondary endpoints include cardio-pulmonary function, activities of daily living (ADL), in-hospital mortality rate and 6-month all-cause mortality rate.DiscussionThis randomized, controlled, clinical trial will assess whether CR improves physical function and reduces rehospitalization in patients hospitalized in CICU with ADHF. The results will provide further research-based evidence for the clinical application of CR in patients with ADHF.Trial RegistrationChinese Clinical Trial Registry ChiCTR2100050151. Registered on 19 August 2021.

Highlights

Heart failure (HF) remains a major public health issue worldwide
The secondary endpoints include cardio-pulmonary function, activities of daily living (ADL), in-hospital mortality rate and 6-month all-cause mortality rate. This randomized, controlled, clinical trial will assess whether cardiac rehabilitation (CR) improves physical function and reduces rehospitalization in patients hospitalized in cardiac intensive care unit (CICU) with Acute decompensated heart failure (ADHF)
Categorical variables were recorded as frequency and percentage (N, %) and performed by χ2 test or Fisher’s exact test as appropriate. This is a study protocol for a single-center, randomized controlled, single-blind clinical trial to evaluate the efficacy and safety of phase I CR in patients hospitalized in CICU with ADHF

Summary

Introduction

Heart failure (HF) remains a major public health issue worldwide. The prevalence of HF still continues to raise due to a growing and aging population and improvements in the treatment of cardiovascular diseases [1]. Impaired exercise capacity in patients with ADHF has detrimental effects on the health-related quality of life (QOL) and adverse outcomes [7]. Exercise-based CR is strongly recommended (Class I, Level A) to improve exercise capacity and QOL as well as reduce HF hospitalization in patients with chronic HF by the 2021 European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic HF [13]. Data on the efficacy and safety of CR in hospitalized patients with ADHF is limited. Cardiac rehabilitation (CR) improves outcomes in patients with heart failure. Data on CR efficacy in patients with acute decompensated heart failure is limited. This study is designed to assess the efficacy and safety of CR in patients hospitalized in cardiac intensive care unit (CICU) with acute decompensated heart failure (ADHF)

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