Sensation of Dyspnea and Experience of Patients With Heart Failure (MOVE)

Hospital de Clinicas de Porto Alegre

Status: Enrolling

Conditions: Decompensated Heart Failure

Treatments: Other: early mobilization protocol; Device: Immersive Virtual Reality glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT05596292

2022-0355

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

early mobilization protocol and immersive virtual reality

Experimental group

Description:

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.

Treatment:

Device: Immersive Virtual Reality glasses

Other: early mobilization protocol

early mobilization protocol

Active Comparator group

Description:

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.

Treatment:

Other: early mobilization protocol