Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure (VIRTUAL-HF)

Valentina Micheluzzi

Status

Not yet enrolling

Conditions

Reduced Ejection Fraction

Heart Failure

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT06115928

AOSassari

Details and patient eligibility

About

Background. To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF undergoing CR in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and rehospitalization rates due to HF (secondary outcomes).

Methods. A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients will receive 30-minute CR sessions twice a week for one month.

Results. Significant improvements in primary and secondary outcomes are expected in patients in the intervention group.

Conclusions. If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age over 18 years;
clinically stable chronic HF diagnosis with left ventricular ejection fraction (LVEF) < 40%

Exclusion criteria

conditions that exclude exercise training (e.g., bone fractures);
conditions that exclude VR use of VR (e.g., blindness and deafness
severe cognitive impairment, documented with a score of 0 - 4 on the Six-item Screener;
end-stage renal disease requiring dialysis;
ascertained advanced pneumopathies;
active neoplasms;
rheumatic diseases.