Sensation of Dyspnea and Experience of Patients With Heart Failure

Not Applicable

Recruiting

• Conditions: Decompensated Heart Failure
• Interventions: Device: Immersive Virtual Reality glasses; Other: early mobilization protocol

• Registration Number: NCT05596292
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

This randomized clinical trial aims to evaluate patients with decompensated heart failure undergoing an early mobilization protocol with the use of immersive virtual reality glasses compared with patients undergoing the same protocol but without immersive virtual reality. The primary outcome will be the sensation of difficulty breathing, and the secondary outcome will be whether this technology provided a positive experience for patients in the intervention group that was superior to that of patients in the control group.

Detailed Description

This randomized clinical trial aims to assess the sensation of dyspnea in patients undergoing an early mobilization protocol with immersive virtual reality and their experience using this technology. The study population consists of patients with acute decompensated heart failure in an intensive care unit at a teaching hospital. The 3-day protocol will include active exercises with an in-bed cycle ergometer, orthostasis, and ambulation. The intervention group will perform all exercises using virtual reality glasses. The variables will be collected before and after each intervention.

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Status Verified: 2022-12
• Study Start: 2022-12-01
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05
• Primary Completion: 2023-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

• Mechanical ventilation or circulatory support
• Neurodegenerative diseases
• Pregnant patients
• Hemodynamic instability at baseline
• Score on the Borg Rating of Perceived Exertion Scale Borg ≥ 4 at rest
• High risk of falls
• Difficulty communicating
• Not adapt with the immersive virtual reality glasses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early mobilization protocol and immersive virtual reality	Immersive Virtual Reality glasses	Three days of an early mobilization protocol using immersive virtual reality glasses. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation. The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360º rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.
early mobilization protocol and immersive virtual reality	early mobilization protocol	Three days of an early mobilization protocol using immersive virtual reality glasses. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation. The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360º rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.
early mobilization protocol	early mobilization protocol	Three days of an early mobilization protocol. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation.

Primary Outcome Measures

Name	Time	Method
Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention	Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality	The evaluation of dyspnea sensation using the Borg Rating Of Perceived Exertion Scale. This scale has a score ranging from zero to 10, and the higher the score the patient reports, the greater the sensation of dyspnea

Secondary Outcome Measures

Name	Time	Method
Patient experience with and without immersive virtual reality during mobilization	Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality	Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil