Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
2. August 2019 aktualisiert von: Ana Laura Ricci-Vitor, Universidade Estadual Paulista Júlio de Mesquita Filho
The aim of this study is to investigate engagement, motivation, and the barriers to adherence of virtual reality based therapy (VRBT) in patients with cardiac diseases and risk factors to the development of cardiac diseases.
In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT).
To do this, patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT.
They will be submitted to an initial evaluation, and then will be random allocated to 12 weeks of intervention and to a final evaluation.
The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks using questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program.
Hemodynamic and autonomic responses will be considered the secondary outcomes being evaluated before, during and after a session at the first, sixth and twelfth week.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Introduction: cardiovascular rehabilitation programs (CR) can promote several benefits in patients with cardiac diseases.
However, there are problems related to the patient adherence in CR.
Some of these problems can be caused to factors like motivation.
Alternative therapies can improve motivation and increase adherence to CR.
In this context, virtual reality based therapy (VRBT), have shown benefits in cardiac patients to pain relief, functional capacity and increasing physical activity levels, but there is no answer whether it can increase engagement and adherence to CR.
In addition, it is important to investigate hemodynamic responses of VRBT.
Objective: investigate engagement, motivation, and the barriers to adherence of VRBT in patients with cardiac diseases and risk factors to the development of cardiac diseases.
In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT).
Methods: patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT.
They will be submitted to an initial evaluation, the intervention and to a final evaluation.
The initial evaluation include eligibility investigation, and after they will be random allocated to the interventions.
The interventions will be performed with a frequency of three times a week, for 12 weeks, and the intensity will be prescribed individually.
The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks according to a recall questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program.
The engagement will be evaluated using the User Engagement Scale (modified).
Motivation will be evaluated using the intrinsic motivation questionnaire.
The barriers will be evaluated using the Barriers Scale of Cardiac Rehabilitation.
Adherence will be evaluated using the presence in the patient's records.
Hemodynamic responses will be evaluated before, during and after a session at the first, sixth and twelfth week using blood pressure, heart rate, respiratory rate, oxygen saturation and rating of perceived exertion.
Autonomic responses will be evaluated using heart rate variability.
Statistical analysis: the data analysis will be evaluated using the two way ANOVA with Bonferroni posttest with significance to p < 0.05.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
68
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brasilien, 19060900
- Laboratório de Fisiologia do Estresse
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
16 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Patients with cardiovascular diseases
- Patients with risk factors to develop cardiovascular diseases
Exclusion Criteria:
- Patients who disagree to participate of any protocol interventions
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Conventional therapy
Exercise-based cardiac rehabilitation
|
Both interventions uses exercises
|
|
Experimental: Virtual reality based therapy
Exercise-based virtual reality
|
Both interventions uses exercises
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Engagement
Zeitfenster: Change from baseline at 12 weeks
|
Measured using the Utrecht engagement scale modified There is 17 items scored from 1 to 7, according to the Likert Scale.
Then, each item is summed and divided for the number of items.
Higher values represent a better engagement.
|
Change from baseline at 12 weeks
|
|
Motivation
Zeitfenster: Change from baseline at 12 weeks
|
Measured using the Intrinsic motivation inventory There is 18 items scored from 1 to 5, according to the Likert Scale.
Then, each item is summed and divided for the number of items.
Higher values represent a better motivation.
|
Change from baseline at 12 weeks
|
|
Barriers to Cardiac Rehabilitation
Zeitfenster: Change from baseline at 12 weeks
|
Measured using Cardiac Rehabilitation Barriers Scale There is 21 items score from 1 to 5, according to the Likert Scale.
Then, each item is summed and divided for the number of items.
Higher values represent a worse outcome.
In addition, there is four subscales: 1) Perceived need/health care factors, 2) Logistical factors, 3) Work/time conflicts, and 4) Comorbidities/functional status.
The subscales are scored in the same way of the total, it means, from 1 to 5 and them dividing from the total number of the items included in the subscale.
|
Change from baseline at 12 weeks
|
|
Adherence to Cardiac Rehabilitation
Zeitfenster: Change from baseline at 12 weeks
|
Measured using the number of cardiac rehabilitation sessions attended
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Change from baseline at 12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Autonomic responses
Zeitfenster: Up to 12 weeks
|
Measured using heart rate variability The heart rate variability will be measured through the following linear indices (SDNN: the standard deviation of normal-to-normal intervals, ms; rMSSD: the root mean square of successive difference between normal intervals,ms; RRtri: triangular index, based on RR intervals,ms; TINN: triangular interpolation of the normal to normal interval between consecutive heart beats, ms; LF: low frequency, nu; HF: high frequency and nonlinear indices,nu.).
In addition the nonlinear indices will be measured (SD1: standard deviation of instant variability beat to beat; SD2: standard deviation of long-term interval between consecutive heart beats).
In general higher values represent a better autonomic response.
|
Up to 12 weeks
|
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Blood pressure
Zeitfenster: Up to 12 weeks
|
Measured using both systolic blood pressure and diastolic blood pressure
|
Up to 12 weeks
|
|
Heart rate
Zeitfenster: Up to 12 weeks
|
Measured using an equipment validated for recording heart rate beat to beat
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Up to 12 weeks
|
|
Respiratory rate
Zeitfenster: Up to 12 weeks
|
Measured using the number of respiratory incursions in one minute
|
Up to 12 weeks
|
|
Oxygen Saturation
Zeitfenster: Up to 12 weeks
|
Measured using an oximeter
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Up to 12 weeks
|
|
Perceived exertion
Zeitfenster: Up to 12 weeks
|
Measured using Borg Scale.
This scale varies from 6 to 20.
|
Up to 12 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Ana Laura Ricci-Vitor, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- da Cruz MMA, Ricci-Vitor AL, Borges GLB, da Silva PF, Turri-Silva N, Takahashi C, Grace SL, Vanderlei LCM. A Randomized, Controlled, Crossover Trial of Virtual Reality in Maintenance Cardiovascular Rehabilitation in a Low-Resource Setting: Impact on Adherence, Motivation, and Engagement. Phys Ther. 2021 May 4;101(5). pii: pzab071. doi: 10.1093/ptj/pzab071.
- Alves da Cruz MM, Ricci-Vitor AL, Bonini Borges GL, Fernanda da Silva P, Ribeiro F, Marques Vanderlei LC. Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):642-649. doi: 10.1016/j.apmr.2019.12.006. Epub 2020 Jan 8.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
19. Dezember 2017
Primärer Abschluss (Tatsächlich)
1. Dezember 2018
Studienabschluss (Tatsächlich)
3. Juni 2019
Studienanmeldedaten
Zuerst eingereicht
6. November 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Dezember 2017
Zuerst gepostet (Tatsächlich)
19. Dezember 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. August 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. August 2019
Zuletzt verifiziert
1. August 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCT400579/2017-0
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Beschreibung des IPD-Plans
After published results,
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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