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

Sponsor

Valentina Micheluzzi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06115928

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Reduced Ejection Fraction	Device: Virtual reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: interventional group Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month with virtual reality.	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®.
No Intervention: control group Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month on standard care (without virtual reality)

Arm

Intervention/Treatment

Experimental: interventional group

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

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®.

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

adherence to cardiac rehabilitation [after 4 weeks]
adherence to cardiac rehabilitation measured as the number of sessions performed, compared to the scheduled sessions expressed as a percentage

Secondary Outcome Measures

Functional capacity [at baseline, after 4 and 8 weeks]
functional capacity in meters with the six minutes walking test
Perceived exertion [at baseline, after 4 and 8 weeks]
with Borg rating of perceived exertion which captures physical activity intensity levels related to heart rate during exercise. The rate is multiplied by 10 to determine the ideal heart rate during aerobic exercise. The Borg scale score ranges from 6 to 20 corresponding to "no effort" and "maximum effort", respectively, equating a minimum of 20% to a max of 100% effort.
Angina [at baseline, after 4 and 8 weeks]
with Canadian Cardiovascular Society (CCS) grading of angina.The CCS classification system employs four grades ranging from I (no physical activity limitation) to IV (inability to perform any physical activity without discomfort).
heart rate [at baseline, after 4 and 8 weeks]
digital monitor
blood pressure [at baseline, after 4 and 8 weeks]
digital monitor
oxygen saturation [at baseline, after 4 and 8 weeks]
digital monitor
Maximal oxygen uptake [at baseline and after 8 weeks]
CPET parameters
Minute ventilation/carbon dioxide production slope [at baseline and after 8 weeks]
CPET parameters
oxygen pulse [at baseline and after 8 weeks]
CPET parameters
NT-probnp [at baseline and after 8 weeks]
blood values
HF-related rehospitalization [after 8 weeks from the stard of the study]
number of rehopedalization related to heart failure
Quality of life of patients with heart failure [at baseline, after 4 and 8 weeks]
with Kansas City Cardiomyopathy Questionnaire (KCCQ) which consists of 23 items to assess physical function, symptoms, social function, self-efficacy and quality of life of patients. KCCQ scores range from 0 to 100 and the scores represent health status as follows: from 0 to 24, very poor to poor; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to excellent.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.