Effects of a Structured Dance Program in Parkinson's Disease. A Greek Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Occurence of Emergent Adverse Events
研究概览
简要总结
Dance for Parkinson's Disease® (DfPD®) is a structured dance program that has never been evaluated in Greek PD population. This study assesses for the first time the efficacy, safety and feasibility of DfPD® program in Greek PD patients.
A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
详细描述
Parkinson's Disease (PD) is an idiopathic, neurodegenerative, and progressive movement disorder caused mainly by dysfunction of dopaminergic cells of the substantia nigra. Numerous studies demonstrate the benefits of regular physical exercise in PD, with aerobic exercise having a greater neuroprotective effect by stimulating brain neuroplasticity. People with PD are more easily motivated to attend dance classes systematically than other forms of exercise, they have a high compliance rate with low dropouts, and often continue to practice dance outside the dance intervention.
DfPD® (Dance for Parkinson's Disease®, or Dance for PD®) was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001.This intervention has previously been shown to exert beneficial effect on QoL, motor functions, cognition, self-efficacy, anxiety and depression in people with PD. To the investigators' knowledge, there is no study investigating the effect of any structured dance program in Greek PD patients. Furthermore, no study to date has investigated the effect of DfPD® on PD patients' fatigue. The present pilot study aimed at evaluating for the first time the efficacy, safety and feasibility of a culturally adjusted DfPD® program in Greek patients with early-to-mid-stage PD.
This is a prospective, non-randomized, uncontrolled, open-label, pilot study. A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Age ≥18 years
- •An established diagnosis of idiopathic PD of an early-to-moderate severity; that is from 0 to 2,5 according to Hoehn and Yahr (H&Y) stages
- •Ability to understand, write and speak in Greek
- •Written consent for participating into the study
排除标准
- •A diagnosis of a non-PD tremor disorder
- •Moderate-to-severe PD (≥3 H&Y stages) due to a high falls risk
- •Serious health or disability issues (either physical or mental) due of which exercise is not permitted and/or basic instructions during the program cannot be followed
- •Mental disorder not related to PD
- •Any disease other than PD which could affect mobility levels
研究组 & 干预措施
Dance for PD® classes
Dance for PD® was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001. It was designed to introduce people with PD to techniques used by dancers to control movement and it integrates different dance genres while participants dance individually and in groups rather than partnered.
干预措施: Dance for PD® classes (Behavioral)
结局指标
主要结局
Occurence of Emergent Adverse Events
时间窗: During the intervention (week 2-9)
Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
Financial Feasibility Assessment
时间窗: During the intervention (week 2-9)
No cost for the studio and the dance instructor.
Change in total score of Parkinson's Disease Questionnaire-8
时间窗: Baseline (week 1), end of intervention (week 10)
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Assessment of Recruitment Rates
时间窗: Start of Recruitment (-3 months), Baseline (week 1)
Target, up to 2 months for 16 participants.
Assessment of Willingness to Continue the Program after the Intervention
时间窗: End of intervention (week 10)
Verbal statement for continuing the program after the end of the intervention
Adherence and Attrition Assessment
时间窗: During the intervention (week 2-9)
Adherence and attrition rates; an adherence rate ≥70% is considered as high in elderly with functional limitations, and attrition rate ≤15% is considered acceptable by the PEDro scale.
次要结局
- Change in total score of Beck Depression Inventory-II(Baseline (week 1), end of intervention (week 10))
- Change in total score of Parkinson Fatigue Scale-16(Baseline (week 1), end of intervention (week 10))
- Change in total score of Berg Balance Scale(Baseline (week 1), end of intervention (week 10))
- Change in Body Mass Index(Baseline (week 1), end of intervention (week 10))
- Change in total score of Montreal Cognitive Assessment(Baseline (week 1), end of intervention (week 10))
研究者
Michail Elpidoforou
Principal Investigator
University of West Attica