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临床试验 NCT05510739 (STEPS-PD) 针对帕金森病，身体活动，电子健康，神经性步态障碍目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Support for Physical Activity in Everyday Life With Parkinson's Disease (STEPS-PD)
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临床试验NCT05510739 (STEPS-PD)是一项针对帕金森病，身体活动，电子健康，神经性步态障碍的干预性研究试验，目前试验状态为进行中但不再招募。试验始于2022年9月19日，计划招募140名患者。该研究由Stiftelsen Stockholms Sjukhem主导，预计于2025年7月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月2日。
简要概括
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.
官方标题
Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology
疾病
帕金森病身体活动电子健康神经性步态障碍出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- STEPS-PD
- StockholmsSjukhem
NCT编号
实际开始日期
2022-09-19
最近更新发布
2025-07-02
预计完成日期
2025-07
计划入组人数
140
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中但不再招募
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | Motor-cognitive Home Exercise Supported by Ehealth Technology 10-week, individualized and progressive exercise program targeting functional strength, cardiovascular fitness and physical activity levels. Cognitive exercises are incorporated with motor exercises as an adjunct to the intervention. |
阳性对照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. | Individualized Home Exercise Program Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The six minute walk test | This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes. | Change in balance performance at 10 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gait parameters during single and dual-task conditions | Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors | Change at 10 weeks |
Quality of life questionnaires | PDQ-39 is disease specific quality of life questionnaire. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 | Change at 10 weeks and one year post-intervention |
Physical activity measured with accelerometers | Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity) | Change at 10 weeks and one year post-intervention |
Dual-task ability during walking | Captured using the Auditory Stroop test during walking and expressed as percentage error of the task | Change at 10 weeks |
Balance ability | MiniBest test. Scoring 0-28, lower scores = greater balance impairment | Change at 10 weeks |
Executive function | Trail making test A \& B. Expressed as time required to perform the test (seconds) | Change at 10 weeks |
Balance Confidence | The Activities-specific Balance Confidence scale is a measure of confidence performing in various activities without losing balance or experiencing unsteadiness. A 16-item self-report measure with items rated on a rating scale that ranges from 0-100. A higher score indicates higher balance confidence. | Change at 10 weeks and one year post-intervention |
Health-related Quality of Life | The EQ-5D is a two-part instrument that measures health-related quality of life. It examines 5 domains of quality of life: mobility, self-care, daily activities, pain, anxiety/depression. It comprises 5 questions and a visual scale. | Change at 10 weeks and one year post-intervention |
Exercise Self-Efficacy | The Exercise Self-Efficacy Scale is an instrument examining confidence regarding carrying out regular physical activities and exercise. Questions are answered on a 4-point rating scale. A higher score indicates greater confidence. | Change at 10 weeks and one year post-intervention |
Walking ability | The Walk-12 questionnaire examines limitations in walking ability. It consists of 12 questions answered on either a 3-point or 5-point rating scale. | Change at 10 weeks and one year post-intervention |
Hospital Anxiety and Depression Scale | A 14-item measure designed to reflect the state of generalised anxiety and depression. The respondent rates each item on a 4-point scale. Higher scores indicate greater levels of anxiety or depression. | Change at 10 weeks and one year post-intervention |
Life Space Assessment | The LSA is a self-report measure of the frequency of independent mobility across 5 life-space levels. Higher scores indicate more life-space and movement throughout the community. | Change at 10 weeks and one year post-intervention in only the final cohort of participants |
Global Positioning System | GPS monitors collecting participant daily location and movement data via latitude and longitude coordinates collected throughout waking hours. | Change at 10 weeks and one year post-intervention in only the final cohort of participants |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
50 Years
适龄性别
全部
- Diagnosis of idiopathic Parkinson´s disease
- Hoehn & Yahr (Parkinsons progression scale) 2-3
- ≥ 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
- 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
Stiftelsen Stockholms Sjukhem卡罗琳学院459 个活跃的临床试验可供探索没有联系数据。
1 位于 1 个国家/地区的研究中心
Stockholms sjukhem, Stockholm, 141 83, Sweden