Clinical trial NCT06115928: Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure
Official title: Effects of VIRTUal reALity on Rehabilitation in Patients With Heart Failure: a Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Reduced Ejection Fraction
Keywords: heart failure
cardiac rehabilitation
virtual reality
treatment adherence and compliance
randomized controlled trial
Lead sponsor: Azienda Ospedaliero Universitaria di Sassari
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: adherence to cardiac rehabilitation
timeFrame: after 4 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: at baseline, after 4 and 8 weeks
measure: Perceived exertion
timeFrame: at baseline, after 4 and 8 weeks
measure: Angina
timeFrame: at baseline, after 4 and 8 weeks
measure: heart rate
timeFrame: at baseline, after 4 and 8 weeks
measure: blood pressure
timeFrame: at baseline, after 4 and 8 weeks
measure: oxygen saturation
timeFrame: at baseline, after 4 and 8 weeks
measure: Maximal oxygen uptake
timeFrame: at baseline and after 8 weeks
measure: Minute ventilation/carbon dioxide production slope
timeFrame: at baseline and after 8 weeks
measure: oxygen pulse
timeFrame: at baseline and after 8 weeks
measure: NT-probnp
timeFrame: at baseline and after 8 weeks
measure: HF-related rehospitalization
timeFrame: after 8 weeks from the stard of the study
measure: Quality of life of patients with heart failure
timeFrame: at baseline, after 4 and 8 weeks
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Valentina Micheluzzi
Study officials:
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