Effects of Multimodal Virtual Reality-based Rehabilitation on Dyspnea, Cardiorespiratory Fitness, Left Ventricular Ejection Fraction, and Quality of Life in CABG Phase II
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- dyspnea by Dyspnea 12 questionnaire
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Group A
Group A: Patients will engage in multimodal circuit training while simultaneously viewing nature scenes through VR in a clinical setting.
干预措施: multimodal circuit training while viewing nature scenes through VR in a clinical setting (Other)
Group B
Group B: Patients will be given multimodal circuit training in real -world clinical setting.
干预措施: multimodal circuit training in a real-world clinical setting (Other)
Group C
Group C: Patients will be given multimodal circuit training through telerehabilitation.
干预措施: multimodal circuit training through telerehabilitation (Other)
结局指标
主要结局
dyspnea by Dyspnea 12 questionnaire
时间窗: 2 months
This 12-item questionnaire was developed to measure the severity of dyspnea. The first seven items of this 4-point Likert-type scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) ask patients about physical difficulties they experience because of dyspnea. The remaining five items of the questionnaire focus on the affective aspects of breathing. The maximum scores for the physical and affective aspects of the questionnaire are 21 and 15, respectively. The minimum total score for the questionnaire is 0, whereas the maximum total score is 36.The higher the score, the more severe will be the dyspnea.
cardiorespiratory fitness by VO2 max (through Cooper 12 min test)
时间窗: 2 months
Cooper proposed an indirect approach to estimate VO2 max based on field data. The test can be easily implemented in a common 400 m track field. After a warmup period of about 10 min, subjects are asked to run/ walk as much distance as possible for 12 min. Cooper conducted the test for 105 subjects and found a positive correlation with the value of VO2max quantified via a formal treadmill test. Cooper used linear regression of the covered distance versus the treadmill-estimated VO2 max to find the following relationship: VO 2 max ≈ 11.288+22.351D12.
left ventricular ejection fraction [LVEF] by echocardiography
时间窗: 2 months
LVEF (Left Ventricular Ejection Fraction) by echocardiography is a key measure of heart function, representing the percentage of blood pumped out of the left ventricle with each heartbeat. It is commonly used to assess cardiac efficiency and detect heart failure or other cardiovascular conditions. Echo provides a non-invasive, real-time evaluation of LVEF, offering insights into the heart's pumping capacity and overall health.
Quality of life by EQ-5D-5L
时间窗: 2 months
The EQ-5D questionnaire was developed to measure self-reported health simply and generically. It contains a descriptive system that includes the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression, and a visual analogue scale (the EQ VAS). Both the descriptive system and the EQ VAS measure the current health of the respondent. Combining the respondents' answers in each of the five dimensions of the descriptive system results in a unique health state. On the EQ-VAS, the respondents rate their current health on a scale ranging from 0 to 100. Zero represents "the worst health you can imagine" and 100 represents "the best health you can imagine".
次要结局
- Sleep by Pittsburgh Sleep Quality Index (PSQI)(2 months)