Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

NCT06115928 | Unknown

• 1 other identifier: AOSassari
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

heart failure; cardiac rehabilitation; virtual reality; treatment adherence and compliance; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• adherence to cardiac rehabilitation

  adherence to cardiac rehabilitation measured as the number of sessions performed, compared to the scheduled sessions expressed as a percentage

  after 4 weeks

Secondary Outcomes (12)

• Functional capacity

  at baseline, after 4 and 8 weeks

• Perceived exertion

  at baseline, after 4 and 8 weeks

• Angina

  at baseline, after 4 and 8 weeks

• heart rate

  at baseline, after 4 and 8 weeks

• blood pressure

  at baseline, after 4 and 8 weeks

Study Arms (2)

interventional group

EXPERIMENTAL

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

Device: Virtual reality

control group

NO INTERVENTION

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

Interventions

Virtual reality 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®.

interventional group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valentina Micheluzzi: lead

Study Sites (1)

Valentina Micheluzzi

Sassari, 07100, Italy

Location

Related Publications (28)

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MeSH Terms

Conditions

Heart Failure; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSN, RN

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)