Clinical trial NCT05596292: Sensation of Dyspnea and Experience of Patients With Heart Failure
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decompensated Heart Failure
Keywords: Early Mobilization
Cardiac Rehabilitation
Virtual reality
Exercise Tolerance
Patient experience
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2022-10-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center randomized parallel controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention
timeFrame: Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality
Secondary outcomes:
measure: Patient experience with and without immersive virtual reality during mobilization
timeFrame: Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Eneida R Rabelo Silva, RN, MSc, ScD
role: PRINCIPAL_INVESTIGATOR
References: