Evaluation of the Benefits of a Group Exercise Program and a Group Exercise and Education Program for Individuals With Parkinson's Disease (BEEP)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- all variables measured at baseline, post intervention, months following, and 9 months following.
研究概览
简要总结
The research outlined in the BEEP proposal aims to test whether a 12 week exercise program alone or combined with a 12 session education program will benefit the physical, emotional and social well being of individuals in early to mid stages of Parkinson's Disease compared to a Control group and whether these benefits are maintained once the programs are complete and over the following 9 months.
详细描述
The BEEP proposal tests whether a 12 week exercise program alone or combined with a 12 session education program will benefit the physical, emotional and social well being of individuals in early to mid stages of Parkinson's Disease and whether these benefits are maintained once the programs are complete.
This is a single blind randomized control trial with pretest and posttests after a 3 month intervention and subsequent follow-up testing at 3 months and 9 months post intervention. The Intervention groups (group exercise, group exercise and education) will be compared to a control group and to each other. Each group will have 15 participants.
The study compares the interventions and control groups to determine the following health outcomes:
- physical performance
- levels of physical and social activity
- perceived quality of life
- perceived self efficacy for managing chronic neurological disease
Analysis of variance will be used to test for group differences.
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
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's Disease or Parkinson Syndrome
- •Stages I-III of disease progression
- •Between 40 and 80 years of age
- •Exclusion criteria:
- •Acute illness
- •History of significant cardio-pulmonary insufficiency/illness or any other condition which limits physical activity.
- •History of neurological disorder other than Parkinson Disease
- •Diagnosis of dementia or significant cognitive impairments.
- •Mental State Exam (Folstein et al, 1975) score of < 20
- •Beck Depression Inventory-II score of > 20 will be excluded.
- •Participation in an organized community exercise program in the past 6 months
排除标准
- 未提供
结局指标
主要结局
all variables measured at baseline, post intervention, months following, and 9 months following.
Stanford Self-Efficacy for Managing Chronic Disease
The Activities-specific Balance Confidence (ABC) Scale
Timed Up and Go Test(TUG)
次要结局
- Northwestern University Disability Scale:
- Schwab & England ADL Scale:) independence in ADL
- Parkinson's Disease Questionnaire - Short Form (PDQ - 8):
- Beliefs about Symptom Specific Expectancies:
- Social and Physical Activities Questionnaire: