跳至主要内容
临床试验/NCT01573260
NCT01573260已完成早期 1 期

Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease: A Randomized Control Study.

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)

研究概览

简要总结

Parkinson's disease involves many motor difficulties as well as non-motor ones. Recent research has strongly suggested that exercise is very important for Parkinson's disease. We are interested especially in dance as a form of exercise, because it combines physical movements with balance tasks, social engagement, and mental stimulation. Therefore, we think dance classes may be a very beneficial exercise for Parkinson's disease; the purpose of this study is to see if Argentinean Tango classes might improve motor and non-motor manifestations of Parkinson's disease.

详细描述

There is accumulating evidence for positive effects of exercise on gait speed, strength, balance, and quality of life for people with PD. Habitual physical activity can lower risk for developing PD. In toxin-induced animal models of PD, exercise may decrease neuronal injury. The key components of an exercise program in PD include: 1) cueing strategies to improve gait; 2) cognitive movement strategies to improve transfers; 3) exercises to improve balance, and 4) training of joint mobility and muscle power to physical capacity. Traditional exercise programs can meet these needs but often they are not very appealing for older adults including patients with PD. Unfortunately more than half of individuals with PD does not meet the recommended daily level physical activity.

There is a connection between music and level of Dopamine, which is pivotal for establishing and maintaining behavior. According to recent study music-induced emotional states can increase dopamine release, partially explaining how musical experiences are so valued and why music is an especially potent pleasurable stimulus for most people, and is frequently used to affect emotional states.

The development of interventions which combine exercise, with accessibility, enjoyability, good motivation to practice regularly improving mood and stimulating cognition would be ideal for individuals with PD. Dance may provide all of these characteristics, and so may be an affective useful and accessible intervention to improve motor impairments. Dance requires dynamic balance and permanent adjustment to the environment at the same time. It promotes enjoyment and encouragement interest in continuing participation. Habitual social dancers have superior balance, gait function, and reaction times compared with age-matched nondancers. Regular dancing improves balance and functional mobility, and increases motivation to continue healthful exercise-related behaviours in older adults.

There is also evidence that exercise has a positive impact on cognitive function in vulnerable populations. Musical exercise improved cognitive function in residents of long- term care facilitations without diagnosis of dementia and in patients with established Alzheimer's disease. Particularly dance produces clinically important changes in measures of mental status and behaviour in patients with moderate to severe dementia.

Social isolation is an important cause of the development of depression in the older population and it may be caused by numbers of factors, including mobility limitations: medical illness, and economic difficulties. The relationship between social isolation and depression is clear, as is the link between social engagement and improved mood and perceived quality of life. There is also an important link between social disengagement, depression and cognitive decline in elderly population. Dance classes occur in a group setting and it is forced social interaction, which may produce noticeable improvement in mood and subsequently decrease cognitive decline.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be eligible for inclusion if they have a diagnosis of idiopathic PD.
  • The subjects must speak either English or French sufficiently to fill out questionnaires and understand the instructions for dance classes (classes will be bilingual).

排除标准

  • Patients who cannot stand for at least 30 min and walk for ≥3 m without an assistive device.
  • Individuals with Hoehn and Yahr stage IV- V (severe and nonambulatory)
  • Dementia, defined according to PD dementia criteria as MMSE< 26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process60
  • Serious hearing and vision problems that could affect the participation in dance classes.
  • Change to dopaminergic therapy over the preceding three months, or changes to antiparkinsonian medication are anticipated during the study protocol
  • Serious medical conditions, including cardiac disease or evidence of musculoskeletal problem which precludes dancing or can be worsened by exercise
  • History of frequent falls, with more than 3 falls in the last 12 months

结局指标

主要结局

Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)

时间窗: 26 weeks

This is the standard scale used for grading severity of PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. It also includes a systematic rated clinical interview assessing cognitive and psychiatric symptoms and motor complications of disease. A Hoehn and Yahr scale (5-point overall disease severity index) is included. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study). Total score for Unified Parkinson Disease Rating Scale is the sum of six subscales, ranging from 0 (best possible outcome) to 60 (worst possible symptoms)

次要结局

  • MiniBESTest(26 weeks)
  • Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging(26 weeks)
  • Freezing of Gait Questionnare (FOG_Q)(26 weeks)
  • The Purdue Pegboard(26 weeks)
  • The Montreal Cognitive Assessment(26 weeks)
  • Adverse Events(12 weeks)
  • The Beck Depression Inventory (BDI)(26 weeks)
  • Apathy Evaluation Scale (AES)(26 weeks)
  • The Krupp Fatigue Severity Scale(26 weeks)
  • The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)(26 weeks)
  • Adherence to Treatment(12 weeks)
  • Clinical Global Impression of Change(26 weeks)
  • Exit Questionnaire(12 weeks)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ron Postuma

Assistant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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