Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- The six minute walk test
研究概览
简要总结
This study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using eHealth methods, among people with Parkinson's disease. The intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. The main hypothesis is that unsupervised motor-cognitive training in the home environment using eHealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.
详细描述
This randomised controlled trial will investigate the efficacy of a motor-cognitive exercise program in the home environment, over a 10-week period, on physical function, and motor-cognitive dual task function as well as physical activity behavior in everyday life. A follow-up assessment comprising health-related questionnaires and physical activity monitoring will be conducted at one year post-intervention. Participants will be recruited through Stockholms sjukhem foundation, Karolinska University and via announcements in relevant forums like for instance the Swedish Parkinson Association. Consenting participants will be randomized to the eHealth Intervention group or the control group condition. Block randomization will be achieved using a computerized random sequence generator. Blinded assessors will perform the pre- and post-intervention testing of physical performance.
The ultimate aim of this project is to provide people with PD with continual long-term and evidence-based rehabilitation in their everyday lives using mobile health technology, to support their self- management and increase their quality of life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson´s disease
- •Hoehn & Yahr (Parkinsons progression scale) 1-3
- •≥ 50 years of age
- •Able to ambulate indoors without mobility aid
- •Able to walk continually with/without a walking aid for at least 6 minutes
排除标准
- •Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points
- •Major problems with freezing and/or two or more falls in the month previous to inclusion
- •Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise
- •Impaired vision and/or impaired communication which hinders participation
- •No internet connection in the home
研究组 & 干预措施
Motor-cognitive exercise using eHealth
10-week eHealth based motor-cognitive home training using digital tablets. Cognitive behavioural strategies to promote increase in physical activity levels (walking). Participants will be encouraged to perform 150 minutes of home exercise per week, occurring on three non-consecutive days.
干预措施: Motor-cognitive home exercise supported by eHealth technology (Behavioral)
Individualised home training program
Participants will receive an individualized home exercise program on paper and one instructional session. They will receive written instructions on performing the program 2-3 times weekly and instructions on exercise progression. They will receive no support during the 10-week period.
干预措施: Individualized home exercise program (Behavioral)
结局指标
主要结局
The six minute walk test
时间窗: Change in balance performance at 10 weeks
This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes.
次要结局
- Quality of life questionnaires(Change at 10 weeks and one year post-intervention)
- Life Space Assessment(Change at 10 weeks and one year post-intervention in only the final cohort of participants)
- Executive function(Change at 10 weeks)
- Gait parameters during single and dual-task conditions(Change at 10 weeks)
- Physical activity measured with accelerometers(Change at 10 weeks and one year post-intervention)
- Walking ability(Change at 10 weeks and one year post-intervention)
- Hospital Anxiety and Depression Scale(Change at 10 weeks and one year post-intervention)
- Dual-task ability during walking(Change at 10 weeks)
- Balance ability(Change at 10 weeks)
- Balance Confidence(Change at 10 weeks and one year post-intervention)
- Health-related Quality of Life(Change at 10 weeks and one year post-intervention)
- Exercise Self-Efficacy(Change at 10 weeks and one year post-intervention)
- Global Positioning System(Change at 10 weeks and one year post-intervention in only the final cohort of participants)
- Balance ability(Change at 10 weeks)
- Executive function(Change at 10 weeks)
- Gait parameters during single and dual-task conditions(Change at 10 weeks)
- Dual-task ability during walking(Change at 10 weeks)