Sensation of Dyspnea and Experience of Patients With Heart Failure

Decompensated Heart Failure Clinical Trial

— MOVE  

Official title:

Sensation of Dyspnea and Experience of Patients With Decompensated Heart Failure Undergoing an Early Mobilization Protocol With Immersive Virtual Reality: a Clinical Trial Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596292
• Other study ID #: 2022-0355
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Eneida R Rabelo Silva, RN, MSc,ScD
• Phone: 55 51998068616
• Email: eneidarabelo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria - Patients with 18 years or older

• Being hospitalized for 24 hours or more
• Diagnosis of acute heart failure decompensated
• Being lucid and colaborative

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

Related Conditions & MeSH terms

• Decompensated Heart Failure
• Dyspnea
• Heart Failure

Intervention

Device:
• Immersive Virtual Reality glasses
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.

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention	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	Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality
Secondary	Patient experience with and without immersive virtual reality during mobilization	Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale	Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality