Clinical trial NCT04336306: Virtual Reality-based Therapy and Barriers in Cardiac Patients
Official title: Cardiovascular Rehabilitation: Insertion of Virtual Reality-based Therapy and Evaluation of Barriers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: sympathetic nervous system
heart rate
blood pressure
virtual reality exposure therapy
barriers to cardiac rehabilitation
motivation
adherence patient
engagement
perceived exertion
oxygen saturation
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of VRBT, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences.

Detailed description: Introduction: Despite the benefits that cardiovascular rehabilitation programs (CR) can promote, there are problems regarding adherence, which can be related to several factors, among them, motivation. Alternative therapies can reflect on motivation and promote increased adherence to CR. In this context, virtual reality-based therapy (VRBT) appears as an option. Additionally, chronic hemodynamic and autonomic repercussions of VRBT in relation to CV still need to be investigated. Objective: To evaluate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of TRV, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences. Methods: cardiac patients or individuals with factors that regularly participate in CR will participate in this study. Patients will be randomly allocated to CR + VRBT intervention or keeping the normal routine. Interventions will be carried out three times a week for 12 weeks. The primary outcome will be to assess chronic hemodynamic repercussions (blood pressure, heart rate, respiratory rate, oxygen saturation and perceived exertion using the Borg scale) and autonomic (linear and non-linear data). The secondary outcome consists of a qualitative assessment through a focus group with patients and a focus group with therapists, in addition, the new questionnaire developed to identify the influence of barriers on patients' adherence to CR will be applied.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cardiovascular disease.
* Clinical diagnosis of cardiovascular risk factors.

Exclusion Criteria:

* Presence exacerbated signs or symptoms.
* Balance problems.

Primary outcomes:
measure: Chronic autonomic response: linear indices
timeFrame: Change from baseline at 6 and 12 weeks
measure: Chronic autonomic response:no linear indices
timeFrame: Change from baseline at 6 and 12 weeks
measure: Blood pressure
timeFrame: Change from baseline at 6 and 12 weeks
measure: Heart rate
timeFrame: Change from baseline at 6 and 12 weeks
measure: Respiratory rate
timeFrame: Change from baseline at 6 and 12 weeks
measure: Oxygen Saturation
timeFrame: Change from baseline at 6 and 12 weeks
measure: Perceived Exertion
timeFrame: Change from baseline at 6 and 12 weeks
Secondary outcomes:
measure: Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality
timeFrame: After 12 weeks
measure: Perception of patients about Virtual reality
timeFrame: After 12 weeks
measure: Barriers identification in frequenters of Cardiovascular Rehabilitation.
timeFrame: After 12 week
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Universidade Estadual Paulista Júlio de Mesquita Filho
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
name: Mayara MA da Cruz, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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):pzab071. doi: 10.1093/ptj/pzab071.
citation: da Cruz MMA, Grigoletto I, Ricci-Vitor AL, da Silva JM, Franco MR, Vanderlei LCM. Perceptions and preferences of patients with cardiac conditions to the inclusion of virtual reality-based therapy with conventional cardiovascular rehabilitation: A qualitative study. Braz J Phys Ther. 2022 May-Jun;26(3):100419. doi: 10.1016/j.bjpt.2022.100419. Epub 2022 May 18.
citation: Alves da Cruz M, Laurino M, Christofaro D, Ghisi G, Vanderlei L. Long-term effects of virtual reality-based therapy in cardiovascular rehabilitation: A longitudinal study. Physiother Theory Pract. 2024 Apr;40(4):727-735. doi: 10.1080/09593985.2022.2160222. Epub 2022 Dec 25.