A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility of randomization procedures (To assess implementation of randomization procedures)
研究概览
简要总结
Primary aim is to conduct a pilot trial to determine:
- The feasibility and efficiency of randomisation procedures and study design
- If recruitment rates are sufficient to adequately power a larger trial
The secondary aim is to determine the efficiency of set dancing in comparison to a control for people with Patkinson's disease.
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 (Outcomes Assessor)
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
- •Have a diagnosis of idiopathic Parkinson's disease (Hackney et al 2007; Marchant et al 2010), stage 1-2.5 on the modified Hoeln and Yahr scale for staging of Parkinson's disease (Batson 2010)
- •Able to walk three meters with an assistive device
- •Over 18 years of age
- •Not pregnant
- •Have access to a computer/DVD player to allow them to participate in the home exercise programme
排除标准
- •A serious cardiovascular and/or pulmonary condition (Lodder et al 2004)
- •A neurological deficit other than Parkinson's disease (Batson 2010; Marchant et al 2010)
- •Evidence of a musculoskeletal problem (Duncan and Earhart 2012), contraindicating participation in exercise participation(Lodder et al 2004)
- •A cognitive or hearing problem which will affect their ability to follow instructions or hear the music (Batson 2010)
- •Participated in regular dance classes in the past six months (Marchant et al 2010)
结局指标
主要结局
Feasibility of randomization procedures (To assess implementation of randomization procedures)
时间窗: This outcome measure will be assessed over a 1 year period from study inception to completion
Attrition (To assess dropout rate during the study)
时间窗: This outcome measure will be assessed over a 1 year period from study inception to completion
Attrition rate of ≤ 20% per group will be deemed acceptable
Recruitment rates (To assess rate, duration and success of recruitment methods)
时间窗: This outcome will be assessed over a one year recruitment period
Recruitment considered successful and feasible is 100 participants are recruited in one year
Resources (To assess availability of personnel and building needed to implement study methodology)
时间窗: This outcome measure will be assessed over a 1 year period from study inception to completion
Document issues regarding availability of personnel or buildings needed to implement study methodology
Intervention adherence (To assess compliance with the dance intervention)
时间窗: This outcome will be assessed during the 10 week set dancing intervention
2\) Intervention will be considered successful if no adverse effects or safety issues are reported and attendance at classes is ≥70%
次要结局
- Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)(This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends)
- Six minute walk test (To assess change in functional endurnace)(This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends)
- Exit Questionnaire (To assess participants satisfaction)(This outcome will be assessed the week after the intervention period ends.)
- The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life)(This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends)
- MiniBESTest (To asses change in balance)(This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends)
研究者
Joanne Shanahan
Joanne Shanahan, B.S.c, MISCP
University of Limerick