Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06896318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives
Sponsor:
Wroclaw University of Health and Sport Sciences
Organization:
Study Overview
Official Title:
Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to evaluate the effectiveness of virtual reality-assisted cardiac rehabilitation compared to conventional cardiac rehabilitation in improving psychological outcomes-depression, stress, anxiety, and kinesiophobia-along with physiological parameters, functional status, physical activity levels, and quality of life in cardiac patients.
Detailed Description:
This single-blind randomized controlled trial will include 60 participants aged 60 years and older undergoing Phase II CR at the Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa, Poland. Participants will be randomly assigned to one of two groups: a conventional CR program or a VR-CR group. Both groups will complete a three-week hospital-based CR program involving structured group exercises, interval cycling, and relaxation sessions. The experimental group will additionally receive eight sessions of immersive VR therapy using the VRTierOne device, consisting of 20-minute sessions twice weekly. These sessions employ interactive and calming virtual environments to promote relaxation and psychological engagement. Outcome measures will be evaluated at baseline (week 0), post-intervention (week 3), and follow-up (week 7). Assessments will include Patient-Reported Outcome Measures for stress, depression, kinesiophobia, and quality of life, physiological metrics (heart rate, blood pressure, metabolic equivalents), HRV, functional capacity (6MWT), and physical activity levels measured using the pedometers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: