An E-therapist: an Interactive Immersive Virtual Reality Exercise Program for People with Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin (HbA1C)
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a virtual reality (VR) based rehabilitation protocol for improvement of blood glucose control and exercise compliance of patients.
Subjects aged 55-85 diagnosed with Type 2 diabetes will be recruited. A written consent will be obtained from subjects. Subjects recruited will be randomly divided into one of the two groups. The VR group will receive an exercise program conducted in elderly centre or a control group will receive home exercise program. The 12-week exercise program will be conducted three times per week and each session will last for one hour. Assessment that takes about one hour to complete will be carried out at baseline, mid-way (6th week) and after the 12-week exercise training. Assessment items include physical, psychosocial and cognitive function. Also, blood test on HbA1c will be carried out at baseline and at the end of the 12-week training. During this course of research, subjects are strongly advised to stay with their present lifestyle and medication.
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 (Outcomes Assessor)
盲法说明
Outcome assessor(s) will be blinded to the allocation of participants throughout the study. The name of the participants and the allocation will be removed from the assessment sheet.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 55 and 80 years with a confirmed diagnosis of type 2 diabetes mellitus (T2DM) and an HbA1c of ≥ 6.5% and ≤ 11%.
排除标准
- •Individuals will be excluded if they have a history of any of the following conditions: cardiac arrest, complex dysrhythmias at rest, complicated myocardial infarction or revascularization procedure, presence of congestive failure, presence of angina, signs or symptoms of post-event myocardial ischemia, renal impairment or proteinuria, hepatic impairment, severe gout or hyperuricemia or uncontrolled hypertension, a fall within the last year, musculoskeletal impairment such as inability to walk independently (after stroke or serious arthritis), neurocognitive disorder, or other diseases that limit their ability to engage in physical activities will be excluded. Individuals enrolled in other physical training programs will also be excluded to ensure any true effect of the proposed intervention can be captured.
结局指标
主要结局
Glycated Hemoglobin (HbA1C)
时间窗: 12 weeks
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
次要结局
- Postural sway(12 weeks)
- Arm Curl Test(12 weeks)
- Chair Sit and Reach Test(12 weeks)
- Executive Function(12 weeks)
- Chair Stand Test(12 weeks)
- Back Scratch Test(12 weeks)
- 8-Foot Up and Go Test(12 weeks)
- Quadriceps strength(12 weeks)
- Hamstring Strength.(12 weeks)
- Aerobic Capacity(12 weeks)
- Forward Version of Digit-Span Test(12 weeks)
- Depression(12 weeks)
- Balance(12 weeks)
- Backward Version of Digit-Span Test(12 weeks)
- Exercise Compliance(12 weeks)
研究者
Dr YU Clare Chung Wah
Assistant Professor
The Hong Kong Polytechnic University