Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Reduced Ejection Fraction
• Interventions: Device: Virtual reality

• Registration Number: NCT06115928
• Lead Sponsor: Valentina Micheluzzi

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Study Start: 2023-12-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional group	Virtual reality	Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month with virtual reality.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
NT-probnp	at baseline and after 8 weeks	blood values
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.
Functional capacity	at baseline, after 4 and 8 weeks	functional capacity in meters with the six minutes walking test
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).
blood pressure	at baseline, after 4 and 8 weeks	digital monitor
Maximal oxygen uptake	at baseline and after 8 weeks	CPET parameters
HF-related rehospitalization	after 8 weeks from the stard of the study	number of rehopedalization related to heart failure
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.
heart rate	at baseline, after 4 and 8 weeks	digital monitor
oxygen saturation	at baseline, after 4 and 8 weeks	digital monitor
Minute ventilation/carbon dioxide production slope	at baseline and after 8 weeks	CPET parameters
oxygen pulse	at baseline and after 8 weeks	CPET parameters

Trial Locations

Locations (1)

Valentina Micheluzzi; 🇮🇹 Sassari, Italy