search
Back to results

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

Primary Purpose

Decompensated Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Immersive Virtual Reality glasses
early mobilization protocol
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Heart Failure focused on measuring Early Mobilization, Cardiac Rehabilitation, Virtual reality, Exercise Tolerance, Patient experience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

early mobilization protocol and immersive virtual reality

early mobilization protocol

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient experience with and without immersive virtual reality during mobilization
Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale

Full Information

First Posted
October 7, 2022
Last Updated
December 1, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
search

1. Study Identification

Unique Protocol Identification Number
NCT05596292
Brief Title
Sensation of Dyspnea and Experience of Patients With Heart Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Heart Failure
Keywords
Early Mobilization, Cardiac Rehabilitation, Virtual reality, Exercise Tolerance, Patient experience

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center randomized parallel controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early mobilization protocol and immersive virtual reality
Arm Type
Experimental
Arm 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.
Arm Title
early mobilization protocol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Immersive Virtual Reality glasses
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
early mobilization protocol
Intervention 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.
Primary Outcome Measure Information:
Title
Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention
Description
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
Time Frame
Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality
Secondary Outcome Measure Information:
Title
Patient experience with and without immersive virtual reality during mobilization
Description
Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale
Time Frame
Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eneida R Rabelo Silva, RN, MSc,ScD
Phone
55 51998068616
Email
eneidarabelo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eneida R Rabelo Silva, RN, MSc, ScD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eneida R Rabelo da Silva, Professor
Phone
55 51 33598084
Email
eneidarabelo@gmail.com
First Name & Middle Initial & Last Name & Degree
Eneida R Rabelo da Silva, RN,ScD
First Name & Middle Initial & Last Name & Degree
Pedro D Lago, ScD
First Name & Middle Initial & Last Name & Degree
João Lucas C Oliveira, RN,ScD
First Name & Middle Initial & Last Name & Degree
Larissa G Caballero, RN
First Name & Middle Initial & Last Name & Degree
Iasmin B Fraga
First Name & Middle Initial & Last Name & Degree
Mauren P Haeffner
First Name & Middle Initial & Last Name & Degree
Marina S Santos, RN

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Mobilization and experience data
IPD Sharing Time Frame
Study Protocol when published
IPD Sharing Access Criteria
When available

Learn more about this trial

Sensation of Dyspnea and Experience of Patients With Heart Failure

We'll reach out to this number within 24 hrs