Effects, Feasibility, and Safety of an Early Mobilization Protocol With Immersive Virtual Reality for Dyspnea in Patients With Acutely Decompensated Heart Failure: The MOVE Randomized Clinical Trial.

Background: Early mobilization seems to benefit patients with acutely decompensated heart failure (ADHF), but its initiation is challenging due to severe dyspnea, clinical instability, and low adherence to treatment. Understanding whether early mobilization has good acceptance, adherence, and safety is key for rehabilitation in this population. Virtual reality (VR) offers a less stressful environment and may reduce dyspnea, yet its effects on ADHF remain unknown. In addition, the feasibility and safety of combining VR with an early mobilization program in the intensive care unit (ICU) setting are not fully established. Objective: This study aimed to assess the effects, feasibility, and safety of an early mobilization protocol combined with immersive VR for dyspnea in patients with ADHF admitted to an ICU. Methods: The Early Mobilization Protocol with Immersive Virtual Reality (MOVE) study is a single-center, parallel, superiority randomized clinical trial conducted from January 2023 to January 2024 in a teaching hospital in Brazil. Patients with ADHF admitted to the ICU who met the eligibility criteria were invited to participate. After informed consent, participants were electronically randomized into the intervention group (IG) and control group (CG). Both groups underwent up to 3 sessions of the early mobilization protocol supervised by a physiotherapist, including upper- and lower-limb cycle ergometry, standing, and ambulation. Additionally, the IG used VR headsets, headphones, and smartphones displaying 360° videos. The primary outcome was dyspnea measured using the modified Borg scale before and after each session. Secondary outcomes included vital signs before and after each session and the occurrence of adverse events. Physiotherapists were blinded to the primary outcome, and all analyses followed the intention-to-treat principle with a blinded statistician. Results: A total of 58 participants were randomized (IG: n=28, 48%; CG: n=30, 52%), with a mean age of 59 (SD 11.6) years; 42 (72%) were men, the mean left ventricular ejection fraction was 26.6% (SD 12.5%), and 28 (48%) were categorized as New York Heart Association class III. Only 43% (25/58) of the participants completed all 3 protocol sessions (IG: 11/28, 39%; CG: 14/30, 47%). Reasons for noncompletion of the protocol included refusal, clinical instability, discharge from the unit, or scheduled procedures. Changes in the mean dyspnea scores were similar between groups (IG: -0.17, SD 1.68; CG: 0.01, SD 1.73; P=.67). The mean vital signs remained within expected clinical ranges, with no differences between groups (all P>.05). No serious adverse events occurred. Conclusions: Early mobilization with or without VR was feasible and safe in ICU patients with ADHF. VR did not significantly reduce dyspnea, but adherence challenges limited protocol completion. These findings suggest that early mobilization can be safely implemented in this population and that future studies should explore strategies to enhance adherence and evaluate the potential benefits of VR in larger cohorts.