Multimodal Exercise Program on Parkinson's Disease Patients With Depression
2018年11月21日 更新者：Chang Gung Memorial Hospital
Effectiveness of Multimodal Exercise Program on Depression and Health-Related Quality of Life in Patients With Parkinson's Disease
Depression symptoms are common in Parkinson's Disease, it affects health-related quality of life.
The evidence showed that exercise improved depression and HRQOL in PD patients.
However, studies rarely considered the appropriate exercise program for PD patients, we want to find the best exercise program for PD patients.
研究概览
详细说明
Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression and HRQOL in PD Patients.
Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017. Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline, week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.
研究类型
介入性
注册 (实际的)
98
阶段
- 不适用
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
40年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- be diagnosed PD in Hoehn and Yahr stage I-II22
- under stable medication treatment at least 3 months
- no disease limiting the patient's ability to perform the exercises
Exclusion Criteria:
- severe cardiovascular disorders
- neuromusculoskeletal disorder
- cognitive impairment
- recent participation in any physiotherapy or rehabilitation program
- have exercise regularly
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
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：control group
Control group maintained their regular lifestyle and received the routine care
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实验性的：exercise group
Participants in the exercise group (EG) were instructed to engage performed exercise at least 3 times per week (30-50 minutes) or 10-15 minutes per section every day to accumulate 150 minutes per week for 8 weeks using disc (DVD) at home.
Main exercise was moderate intensity aerobic exercise, an intensity of 55-70% of the heart rate reserve (HR max).
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A step aerobics exercise lasted a total 30 minutes, including:
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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 |
|---|---|---|
|
GDS-15
大体时间：3 minutes
|
consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986).
Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.
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3 minutes
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PDQ-8
大体时间：3 minutes
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A sub-set of items is then selected from the PDQ-39 to create a shorter form version, the PDQ-8 (Jenkinson, Fitzpatrick & Peto, 1997).
The sum of the scores can provide a single figure used to assess the overall health-related quality of life profile of the individual questioned. .
Scores for each dimension range from 0 to 100, PDQ-8SI scores can be standardized on a scale from 0 to 100, with lower scores indicating better HRQoL.
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3 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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UPDRS part II (ADL)
大体时间：5 minutes
|
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987).
The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
A total of 199 points are possible (199 represents the worst disability and 0 no disability).
Part II: self-evaluation of the activities of daily life (ADLs).
The scales part 2: motor experiences of daily living (13 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
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5 minutes
|
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UPDRS part III (motor ability)
大体时间：10 minutes
|
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987).
The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
Its 42 items are evaluated by interview and clinical observation.
The motor section in particular to follow the progression of a person's Parkinson's disease.
A total of 199 points are possible (199 represents the worst disability and 0 no disability).
The scales part 3: motor examination (18 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
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10 minutes
|
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Fatigue (FSS)
大体时间：5 minutes
|
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989).
The subject is asked to read each statement and circle a number from 1 to 7, the items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree.
The minimum score=9 and maximum score possible=63.
Higher the score=greater fatigue severity.
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5 minutes
|
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Sleep quality (PSQI)
大体时间：5 minutes
|
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989).
It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.
A total score of "5" or greater is indicative of poor sleep quality.
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5 minutes
|
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Anxiety (HAS)
大体时间：3 minutes
|
The Hospital Anxiety Scale (HAS), a self-assessment scale, was developed to detect states of, anxiety and emotional distress, used to screen for the presence of anxiety, in a general medical population of patients (Zigmond & Snaith, 1983).
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety.
For both scales, scores of less than 7 indicate normal, 8-10 indicate mild anxiety, 11-14 indicate moderate anxiety and 15-21 severe anxiety.
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3 minutes
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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。
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)
2016年3月1日
初级完成 (实际的)
2017年1月1日
研究完成 (实际的)
2017年1月1日
研究注册日期
首次提交
2018年10月31日
首先提交符合 QC 标准的
2018年11月21日
首次发布 (实际的)
2018年11月26日
研究记录更新
最后更新发布 (实际的)
2018年11月26日
上次提交的符合 QC 标准的更新
2018年11月21日
最后验证
2018年10月1日
更多信息
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.
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