Physical Activity in Persons With Parkinson's Disease (ActivPARK)
2026年5月13日 更新者：Erika Franzén、Karolinska Institutet
Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study
This project aims to identify why some people with Parkinson's disease (PwPD) become less physically active, and which factors support or hinder activity. Understanding these factors is essential for developing person centred interventions and effective support that can be implemented in routine healthcare. A national, multicentre longitudinal cohort study will be conducted including approx 450 PwPD from five Swedish regions (including the internal pilot NCT06901869). Physical activity will be measured objectively with activity monitors, combined with clinical assessments and digital questionnaires over four years. The primary outcome is physical activity level (accelerometer measured decline), and exposure variables include physical, cognitive, disease specific, social, environmental, motivational, and personal factors. Data collection involves clinical tests, questionnaires, accelerometer data, and patient reported experiences.
This is a continuation of an internal pilot study NCT06901869. The study will enable early identification of those at risk for declining activity and guide development of person centred, evidence based interventions. Long term, it aims to integrate activity monitoring and risk factor screening into routine care to improve health and quality of life for PwPD.
研究概览
研究类型
观察性的
注册 (估计的)
450
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Compliance Office Karolinska Insitutet
- 电话号码：+46852480000
- 邮箱：compliance@ki.se
研究联系人备份
- 姓名：Erika Franzén
- 电话号码：+46852488878
- 邮箱：erika.franzen@ki.se
学习地点
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-
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Stockholm、瑞典
- 招聘中
- Karolinska University Hospital
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接触：
- Erika Franzén, PhD
- 电话号码：+46852488878
- 邮箱：erika.franzen@ki.se
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接触：
- LIsa Sandberg, MSc
- 邮箱：lisa.sandberg@ki.se
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
描述
Inclusion Criteria:
- People diagnosed with idiopathic Parkinson's disease
- Hoehn & Yahr 1 to 4
Exclusion Criteria:
- Hoehn & Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
- Unable to perform critical physical activity and clinical assessments
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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People with Parkinson´'s disease
No intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physical activity - low and moderate intensity
大体时间：Baseline and yearly follow-ups for 3 years
|
The primary outcome is changes over time in PA (i.e.
low + moderate-vigorous intensity PA in time spent per day) measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
|
Baseline and yearly follow-ups for 3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical activity - total vector magnitude
大体时间：Baseline and yearly follow-ups for 3 years
|
The secondary outcomes are change over time in total vector magnitude measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
|
Baseline and yearly follow-ups for 3 years
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Physical activity - low intensity
大体时间：Baseline and yearly follow-ups for 3 years
|
The secondary outcomes are change in time spent in low intensity physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
|
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Physical activity - moderate high intensity
大体时间：Baseline and yearly follow-ups for 3 years
|
The secondary outcomes are change in time spent in moderate-vigorous physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
|
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Physical activity- sedentary
大体时间：Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in sedentary time per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - steps
大体时间：Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in steps per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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认知表现
大体时间：基线和3年随访
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用蒙特利尔认知评估（MOCA）评估，0-25，更高的分数=更好
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基线和3年随访
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Disease severity, Parkinsons symptoms
大体时间：Baseline and 3 year follow-up
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Disease severity measured with the Movement Disorders Society -Unified Parkinson's Disease Rating Scale) parts 1 to 4. Higher scores = worse/more symptoms |
Baseline and 3 year follow-up
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Gait
大体时间：Baseline and 3 year follow-up
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Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
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Baseline and 3 year follow-up
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Balance performance
大体时间：Baseline and 3 year follow-up
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Assessed with the Mini-BESTest.
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. 0-28 points with higher scores indicating better balance control
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Baseline and 3 year follow-up
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Anxiety and depression
大体时间：Baseline and yearly follow-ups for 3 years
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Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively.
Lower score=better
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Baseline and yearly follow-ups for 3 years
|
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Motivation
大体时间：Baseline and yearly follow-ups for 3 years
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Assessed with the Behavioural Regulation in Exercise Questionnaire (BREQ 4), a 28-item survey that measures exercise motivation.
The questionnaire uses a 7-point Likert scale, ranging from one to seven.
Maximum 196.
Higher scores = higher motivation
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Baseline and yearly follow-ups for 3 years
|
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Self-efficacy
大体时间：Baseline and yearly follow-ups for 3 years
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Assessed with the Self-efficacy and motivation for exercise/physical activity (ESES).
10 questions rated on a 4 point Likert scale.
Maximun 40 points, higher scores= better self-efficacy
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Baseline and yearly follow-ups for 3 years
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Physical activity history and preferences,
大体时间：Baseline
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Self-made questions on physical activity history and preferences
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Baseline
|
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Self assessed cognitive function
大体时间：Baseline and yearly follow-ups for 3 years
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Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse
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Baseline and yearly follow-ups for 3 years
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Non-Motor Symptoms
大体时间：Baseline and yearly follow-ups for 3 years
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Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer.
More yes answers = more non-motor symptoms
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Baseline and yearly follow-ups for 3 years
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Walking ability- self rated
大体时间：Baseline and yearly follow-ups for 3 years
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WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
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Baseline and yearly follow-ups for 3 years
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Freezing of gait - self-assessed
大体时间：Baseline and 3 year follow-up
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Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
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Baseline and 3 year follow-up
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Balance confidence
大体时间：Baseline and yearly follow-ups for 3 years
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Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
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Baseline and yearly follow-ups for 3 years
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Fatigue
大体时间：Baseline and yearly follow-ups for 3 years
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Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree .
more points/score= worse.
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Baseline and yearly follow-ups for 3 years
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Disability
大体时间：Baseline and 3 year follow-up
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World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
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Baseline and 3 year follow-up
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Sleep
大体时间：Baseline and 3 year follow-up
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Scales for Outcomes in Parkinson's disease - Sleep (SCOPA-SLEEP), 4 parts, A-2 questions, B-5 questions , C-1 question and D- 6 questions.
Higher= worse
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Baseline and 3 year follow-up
|
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Self-rated pain
大体时间：Baseline and yearly follow-ups for 3 years
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Assessed with visual analog scale, VAS from 0 to 100
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Baseline and yearly follow-ups for 3 years
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Health related quality of life
大体时间：Baseline and yearly follow-ups for 3 years
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Parkinson's Disease Questionnaire (PDQ39).
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communications and bodily discomfort).
The sum score is as a percentage score ranging between 0 and 100.
Higher is better
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Baseline and yearly follow-ups for 3 years
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Wellbeing
大体时间：Baseline and yearly follow-ups for 3 years
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The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
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Baseline and yearly follow-ups for 3 years
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Nutrition
大体时间：Baseline and 3 year follow-up
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Mini Nutritional Assessment, max 14. higher = better
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Baseline and 3 year follow-up
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Socioeconomic status
大体时间：Baseline
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Education and income level.
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Erika Franzén、Karolinska Institutet
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月15日
初级完成 (估计的)
2030年12月31日
研究完成 (估计的)
2031年1月30日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月7日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 4-438/2024
- 2024-07526-01 (其他标识符：Swedish Ethical Review Authority)
- 06901869 (其他标识符：Clinical Trials registration -pilot study)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request.
Any sharing of data will be regulated via a data transfer and user agreement with the recipient, provided that the recipient has an approved ethics application.
IPD 共享时间框架
We plan to share this when applicable on OSF or similar
IPD 共享访问标准
The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request.
Any sharing of data will be regulated via a data transfer and user agreement with the recipient.
IPD 共享支持信息类型
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.