Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in Physical Activity Level
研究概览
简要总结
Persons with Parkinson Disease (PD) face significant declines in function resulting in greater disability. Function can improve through participation in exercise, yet many people with PD are physically inactive. Given that people with PD live long lifespans following diagnosis; it is essential to include routine exercise into their lives over the long-term. Physical therapy is effective in improving function in persons with PD. However, participation in on-going physical therapy indefinitely is not a realistic option due to limited healthcare resources. Interventions using mobile health technologies allow physical therapists to stay connected to patients over time potentially improving their ability to meet the changing needs of patients with PD. Innovative approaches using mobile health technology may improve outcome; however, the effectiveness of different approaches to improve function and reduce disability in PD is unknown.
The purpose of this study is to compare the effectiveness of two interventions to improve function and health-related quality of life in 65 people with PD. In one study group, participants receive a home exercise program, in written format, to continue on an independent basis. In the other study group, participants are instructed to continue with an exercise program, in their home, delivered using videos of the exercises on a computer tablet device. This use of mobile-Health technology allows the physical therapist to remotely monitor participants' progress and modify the exercise program to meet the changing needs of each patient. The long-term objective of this research is to determine the most efficient and effective way to improve function that can be widely disseminated to persons with PD.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inactive over the last 3 months
- •Clinical diagnosis of idiopathic Parkinson's disease
- •Mild to moderate disease severity
- •Sufficient cognitive ability to follow study instructions
- •Stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 12 month study period unless medically necessary
- •Able to walk without physical assistance or an assistive device for at least 6 continuous minutes
- •Be interested in participating and provide informed consent
排除标准
- •A diagnosis of atypical Parkinsonism
- •Balance impairment (More than 2 falls in the previous month)
- •Significant freezing
- •Serious co-morbidities or medical conditions that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
研究组 & 干预措施
Mobile Health Technology
Stretching and strengthening exercises provided via video using mobile health technology; walk daily using a pedometer; interact with a physical therapist remotely through an exercise application on a tablet device over 12 month period
干预措施: Mobile Health Technology (Behavioral)
Mobile Health Technology
Stretching and strengthening exercises provided via video using mobile health technology; walk daily using a pedometer; interact with a physical therapist remotely through an exercise application on a tablet device over 12 month period
干预措施: Stretching & Strengthening Exercises (Behavioral)
Mobile Health Technology
Stretching and strengthening exercises provided via video using mobile health technology; walk daily using a pedometer; interact with a physical therapist remotely through an exercise application on a tablet device over 12 month period
干预措施: Walking with Pedometer (Behavioral)
Control
Stretching and strengthening exercises provided using printed photographs; walk daily using a pedometer; interact with a physical therapist at the beginning of the 12 month study; no use of mobile technology
干预措施: Walking with Pedometer (Behavioral)
Control
Stretching and strengthening exercises provided using printed photographs; walk daily using a pedometer; interact with a physical therapist at the beginning of the 12 month study; no use of mobile technology
干预措施: Stretching & Strengthening Exercises (Behavioral)
结局指标
主要结局
Change from Baseline in Physical Activity Level
时间窗: 52-54 weeks
Physical activity level will be assessed using an activity monitor worn around the ankle over a 7-day period at the beginning and the end of the study
次要结局
- Change from Baseline in Geriatric Depression Scale(52-54 weeks)
- Change from Baseline in BriefBEST Balance Test(52-54 weeks)
- Change from Baseline in Falls Self-Efficacy Scale International(52-54 weeks)
- Change from Baseline in Parkinson's Disease Questionnaire-39(52-54 weeks)
- Change from Baseline in Fatigue Severity Scale(52-54 weeks)
- Change from Baseline in Six Minute Walk Test(52-54 weeks)
- Change from Baseline in Unified Parkinson's Disease Rating Scale(52-54 weeks)
- Change from Baseline in Godin Leisure-Time Exercise Questionnaire(52-54 weeks)
- Change from Baseline in Self-Efficacy Exercise Scale(52-54 weeks)
- Change from Baseline in Functional Gait Assessment(52-54 weeks)
- Change from Baseline Apathy Scale(52-54 weeks)
研究者
Theresa D Ellis
Assistant Professor and Director of Center for Neurorehabilitation
Boston University