Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

NCT ID: NCT06115928

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

interventional group

Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month with virtual reality.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: DEVICE

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

control group

Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month on standard care (without virtual reality)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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®.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valentina Micheluzzi

OTHER

Sponsor Role: lead

Responsible Party

Valentina Micheluzzi

MSN, RN

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Valentina Micheluzzi

Sassari, , Italy

Countries

Italy

Facility Contacts

Valentina Micheluzzi, MSN, RN

Role: primary

valentina.micheluzzi@aouss.it

3401753630

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Other Identifiers

AOSassari

Identifier Type: -

Identifier Source: org_study_id