The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 45
- 主要终点
- Level of Physical Activity based on the LAPAQ questionnaire
研究概览
简要总结
Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. First, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly, physical activity has additional disease-specific merits in PD such as depression, sleep disturbances and constipation. These effects lead to raised quality of life. Furthermore, animal studies suggest that physical activity could slow down disease progression.
Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity.
Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD.
The second aim is to demonstrate an increase in physical fitness and quality of life.
详细描述
no extensive description
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD
- •Hoehn and Yahr stage I-III
- •Between 40 and 75 years old
- •Not meeting the norm for healthy physical activity: the latter being defined according to international standards as either five days a week 30 minutes of moderate-intensity physical activity, or 3 days a week 20 minutes of vigorous-intensity physical activity
排除标准
- •Wheel chair bounded
- •Severe co-morbidity (e.g. orthopaedic disorders or chronic hart failure)
- •Severe cognitive decline, defined as Mini Mental State Examination < 24
研究组 & 干预措施
A
Physical Therapy aimed to promote the level of physical activity
干预措施: Physical Therapy aimed to improve Physical Activity (Other)
B
Physical Therapy aimed to move safely
干预措施: Physical therapy aimed to move safely (Other)
结局指标
主要结局
Level of Physical Activity based on the LAPAQ questionnaire
时间窗: Average of 6, 12, 18 and 24 months
次要结局
- disease severity ( Nine Hole Peg test, UPDRS)(12 and 24 months)
- Fatigue (FSS)(6, 12, 18 and 24 months)
- Level of Physical Activity based on an activity monitor(continuous during 24 months)
- Quality of Life (PDQ-39)(6, 12, 18 and 24 months)
- Mood and Depression (HADS)(6, 12, 18 and 24 months)
- Safety(Falls)(monthly)
- Medication (questionnaire)(6, 12, 18 and 24 months)
- One week diary of physical activity(Average of 6, 12, 18 and 24 months)
- Physical Fitness (Six Minute Walk Test & Astrand bicycle test)(12 and 24 months)
- Cognition (CANTAB)(12 and 24 months)
- Medical Costs (questionnaire)(6, 12, 18 and 24 months)
- Quality of Sleep (SCOPA-sleep)(6, 12, 18 and 24 months)
- Mobility (Timed up and go test)(12 and 24 months)
研究者
dr Marten Munneke, PT
Dr
Radboud University Medical Center