Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

Heart Failure Clinical Trial

— VIRTUAL-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115928
• Other study ID #: AOSassari
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: Azienda Ospedaliero Universitaria di Sassari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Reduced Ejection Fraction

Intervention

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®.

Locations

Country	Name	City	State
Italy	Valentina Micheluzzi	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
Valentina Micheluzzi

Country where clinical trial is conducted

Italy, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional capacity	functional capacity in meters with the six minutes walking test	at baseline, after 4 and 8 weeks
Secondary	Perceived exertion	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.	at baseline, after 4 and 8 weeks
Secondary	Angina	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).	at baseline, after 4 and 8 weeks
Secondary	heart rate	digital monitor	at baseline, after 4 and 8 weeks
Secondary	blood pressure	digital monitor	at baseline, after 4 and 8 weeks
Secondary	oxygen saturation	digital monitor	at baseline, after 4 and 8 weeks
Secondary	Maximal oxygen uptake	CPET parameters	at baseline and after 8 weeks
Secondary	Minute ventilation/carbon dioxide production slope	CPET parameters	at baseline and after 8 weeks
Secondary	oxygen pulse	CPET parameters	at baseline and after 8 weeks
Secondary	NT-probnp	blood values	at baseline and after 8 weeks
Secondary	HF-related rehospitalization	number of rehopedalization related to heart failure	after 8 weeks from the stard of the study
Secondary	Quality of life of patients with heart failure	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.	at baseline, after 4 and 8 weeks