NCT06115928

Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

Effects of VIRTUal reALity on Rehabilitation in Patients With Heart Failure: a Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Valentina Micheluzzi · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure
• Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	Virtual reality	Participants will perform cardiac rehabilitation with hardware-type technology consisting of a PICO 4® head mounted display (HMD) headset and the software TREADMILL XR®.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2023-11-03
• Last updated: 2023-11-03

Locations

1 site across 1 country: Italy