Multimodal VR Rehabilitation for Cardiorespiratory Fitness in CABG Phase II

Официальное название

Effects of Multimodal Virtual Reality-based Rehabilitation on Dyspnea, Cardiorespiratory Fitness, Left Ventricular Ejection Fraction, and Quality of Life in CABG Phase II

Обзор

It will be a randomized clinical trial with a sample size of 66. A convenient sampling technique will be used to recruit the CABG phase II patients for the study. Then, they will be divided into three groups by block randomization. Weight-bearing Liuzijue Qigong will be given as a baseline treatment to all groups. In group A, patients will engage in multimodal circuit training while simultaneously viewing the nature scenes through VR in a clinical setting, in group B, patients will be given multimodal circuit training in a clinical setting while in group C, patients will be given multimodal circuit training through telerehabilitation. The dyspnea 12 Questionnaire will be used for measuring dyspnea, Cooper's 12-minute test will be used to assess cardiorespiratory fitness, echocardiography will be used to assess Left ventricular ejection fraction, EQ-5D-5L will be used to assess quality of life, and Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep. Data will be entered and analyzed through SPSS version 21.

Подробное описание

CABG Phase II rehabilitation typically begins a few weeks after hospital discharge and is a structured, medically supervised program aimed at stabilizing patients post-surgery. During this phase, patients often struggle with limited physical capacity, reduced exercise tolerance, and fatigue. Effective cardiac rehabilitation during this critical recovery phase is essential for optimizing health outcomes. Multimodal rehabilitation approaches have been shown to enhance recovery. The integration of innovative techniques like Virtual Reality (VR) into these multimodal programs can further engage patients. The objective of the study is to determine the effects of multimodal virtual reality-based rehabilitation on dyspnea, cardiorespiratory fitness, left ventricular ejection fraction, and quality of life in CABG phase II patients.

It will be a randomized clinical trial with a sample size of 66. A convenient sampling technique will be used to recruit the CABG phase II patients for the study. Then, they will be divided into three groups by block randomization. Weight-bearing Liuzijue Qigong will be given as a baseline treatment to all groups. In group A, patients will engage in multimodal circuit training while simultaneously viewing the nature scenes through VR in a clinical setting, in group B, patients will be given multimodal circuit training in a clinical setting while in group C, patients will be given multimodal circuit training through telerehabilitation. The dyspnea 12 Questionnaire will be used for measuring dyspnea, Cooper's 12-minute test will be used to assess cardiorespiratory fitness, echocardiography will be used to assess Left ventricular ejection fraction, EQ-5D-5L will be used to assess quality of life, and Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep. Data will be entered and analyzed through SPSS version 21.

Вмешательства

• Другое multimodal circuit training while viewing nature scenes through VR in a clinical setting
  This will take place in a clinical setting where participants will also view the nature scenes through virtual reality (VR). The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.
• Другое multimodal circuit training in a real-world clinical setting
  This will take place in a real-world clinical setting. The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.
• Другое multimodal circuit training through telerehabilitation
  This will take place through Google Meetings. The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Первичные конечные точки

• dyspnea by Dyspnea 12 questionnaire [Срок оценки: 2 months]
• cardiorespiratory fitness by VO2 max (through Cooper 12 min test) [Срок оценки: 2 months]
• left ventricular ejection fraction [LVEF] by echocardiography [Срок оценки: 2 months]
• Quality of life by EQ-5D-5L [Срок оценки: 2 months]

Вторичные конечные точки (1)

• Sleep by Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Patients who underwent CABG surgery will be recruited after twelve weeks
• Both male and female
• Age 30-60 years old
• LVEF of < 40%
• Persistent dyspnea with a self-rated intensity of ⩾5 (out of 10) on a visual analogue dyspnea scale (this dyspnea rating was only used as an inclusion criterion and not as a measure for outcome)
• Preserved cognitive function (Montreal Cognitive Assessment score >24)

Критерии исключения

• Patient with recurrent history of CABG
• Had a non-cardiac surgical procedure ≤2 months prior to recruitment
• Unstable angina, uncontrolled hypertension (blood pressure >180/100 mmHg), a pacemaker or atrial fibrillation, documented peak orifice area valve stenosis, symptomatic peripheral arterial disease that limits exercise capacity.
• Documented chronic obstructive pulmonary disease (FEV1 <60% and FVC <60%)
• Any shoulder impairment that would limit exercise participation
• Patients with Kinesiophobia
• Epilepsy, vertigo, eyesight impairment (conditions contraindicated for VR)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Riphah International University — Lahore

Публикации

• Elbrond P, Hojskov IE, Missel M, Borregaard B. Food and heart-the nutritional jungle: Patients' experiences of dietary habits and nutritional counselling after coronary artery bypass grafting. J Clin Nurs. 2020 Jan;29(1-2):85-93. doi: 10.1111/jocn.15061. Epub 2019 Oct 2. PMID 31512796
• Ramos-Campo DJ, Andreu Caravaca L, Martinez-Rodriguez A, Rubio-Arias JA. Effects of Resistance Circuit-Based Training on Body Composition, Strength and Cardiorespiratory Fitness: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Apr 28;10(5):377. doi: 10.3390/biology10050377. PMID 33924785
• Zamzmi G, Rajaraman S, Hsu LY, Sachdev V, Antani S. Real-time echocardiography image analysis and quantification of cardiac indices. Med Image Anal. 2022 Aug;80:102438. doi: 10.1016/j.media.2022.102438. Epub 2022 Jun 9. PMID 35868819
• Gungor S, Tosun B, Unal N, Dusak I. Evaluation of dyspnea severity and sleep quality in patients with novel coronavirus. Int J Clin Pract. 2021 Oct;75(10):e14631. doi: 10.1111/ijcp.14631. Epub 2021 Jul 20. PMID 34260144
• Rutkowski S, Szczegielniak J, Szczepanska-Gieracha J. Evaluation of the Efficacy of Immersive Virtual Reality Therapy as a Method Supporting Pulmonary Rehabilitation: A Randomized Controlled Trial. J Clin Med. 2021 Jan 18;10(2):352. doi: 10.3390/jcm10020352. PMID 33477733
• Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148. PMID 34065625
• Moneruzzaman M, Sun WZ, Changwe GJ, Wang YH. Efficacy of Multiple Exercise Therapy after Coronary Artery Bypass Graft: A Systematic Review of Randomized Control Trials. Rev Cardiovasc Med. 2023 May 9;24(5):141. doi: 10.31083/j.rcm2405141. eCollection 2023 May. PMID 39076757
• Dimitriadis S, Qian E, Irvine A, Harky A. Secondary Prevention Medications Post Coronary Artery Bypass Grafting Surgery-A Literature Review. J Cardiovasc Pharmacol Ther. 2021 Jul;26(4):310-320. doi: 10.1177/1074248420987445. Epub 2021 Jan 29. PMID 33514291

Идентификаторы

NCT: NCT07331558 · Amna Zafar

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗