Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
2019年8月2日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
68
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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São Paulo
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Presidente Prudente、São Paulo、ブラジル、19060900
- Laboratório de Fisiologia do Estresse
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
14年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Conventional therapy
Exercise-based cardiac rehabilitation
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Both interventions uses exercises
|
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実験的:Virtual reality based therapy
Exercise-based virtual reality
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Both interventions uses exercises
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Engagement
時間枠: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.
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Change from baseline at 12 weeks
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Motivation
時間枠:Change from baseline at 12 weeks
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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.
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Change from baseline at 12 weeks
|
|
Barriers to Cardiac Rehabilitation
時間枠:Change from baseline at 12 weeks
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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.
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Change from baseline at 12 weeks
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Adherence to Cardiac Rehabilitation
時間枠:Change from baseline at 12 weeks
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Measured using the number of cardiac rehabilitation sessions attended
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Change from baseline at 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Autonomic responses
時間枠:Up to 12 weeks
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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.
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Up to 12 weeks
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Blood pressure
時間枠:Up to 12 weeks
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Measured using both systolic blood pressure and diastolic blood pressure
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Up to 12 weeks
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Heart rate
時間枠:Up to 12 weeks
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Measured using an equipment validated for recording heart rate beat to beat
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Up to 12 weeks
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Respiratory rate
時間枠:Up to 12 weeks
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Measured using the number of respiratory incursions in one minute
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Up to 12 weeks
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Oxygen Saturation
時間枠:Up to 12 weeks
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Measured using an oximeter
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Up to 12 weeks
|
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Perceived exertion
時間枠:Up to 12 weeks
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Measured using Borg Scale.
This scale varies from 6 to 20.
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Up to 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Ana Laura Ricci-Vitor, PhD、Universidade Estadual Paulista Julio de Mesquita Filho
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年12月19日
一次修了 (実際)
2018年12月1日
研究の完了 (実際)
2019年6月3日
試験登録日
最初に提出
2017年11月6日
QC基準を満たした最初の提出物
2017年12月13日
最初の投稿 (実際)
2017年12月19日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月5日
QC基準を満たした最後の更新が送信されました
2019年8月2日
最終確認日
2019年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NCT400579/2017-0
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
After published results,
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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