Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.

NCT03377582 | Completed DMC

• 1 other identifier: NCT400579/2017-0
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Disease; Risk Factor, Cardiovascular

Keywords

cardiovascular diseases; cardiac rehabilitation; sympathetic nervous system; heart rate; blood pressure; clinical trial; virtual reality exposure therapy; barriers to cardiac rehabilitation; motivation; adherence patient; engagement; perceived exertion; oxygen saturation

Outcome Measures

Primary Outcomes (4)

• Engagement

  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

  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

  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

  Measured using the number of cardiac rehabilitation sessions attended

  Change from baseline at 12 weeks

Secondary Outcomes (6)

• Autonomic responses

  Up to 12 weeks

• Blood pressure

  Up to 12 weeks

• Heart rate

  Up to 12 weeks

• Respiratory rate

  Up to 12 weeks

• Oxygen Saturation

  Up to 12 weeks

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

Exercise-based cardiac rehabilitation

Other: Exercise

Virtual reality based therapy

EXPERIMENTAL

Exercise-based virtual reality

Other: Exercise

Interventions

Exercise OTHER

Both interventions uses exercises

Conventional therapy; Virtual reality based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cardiovascular diseases
• Patients with risk factors to develop cardiovascular diseases

You may not qualify if:

• \- Patients who disagree to participate of any protocol interventions

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Laboratório de Fisiologia do Estresse

Presidente Prudente, São Paulo, 19060900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33625515 DERIVED

• 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.

  PMID: 31926142 DERIVED

MeSH Terms

Conditions

Heart Diseases; Cardiovascular Diseases; Patient Compliance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ana Laura Ricci-Vitor, PhD

  Universidade Estadual Paulista Júlio de Mesquita Filho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 19, 2017
• Study Start: December 19, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 3, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)