A Randomized Controlled Feasibility Trial to Determine the Effectiveness of Set Dancing for People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (To assess change in balance)
研究概览
简要总结
The aim of this study is to investigate if set dancing is beneficial and feasible for those with Parkinson's disease in Ireland. The hypothesis of this feasibility study are that:
- Participants will be able to partake fully in the intervention without reporting adverse events.
- There will be evidence of gains in functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease who participate in eight weeks of set dancing classes compared to a control group.
详细描述
Background: Previous research has found that people with Parkinson's disease who participate in dance classes have improved functional exercise capacity, mobility, balance and quality of life (Duncan and Earhart 2012; Hackney and Earhart 2009). Dance may be an effective intervention for people with Parkinson's disease as it targets key components of rehabilitation programmes for people with Parkinson's disease (Earhart 2009). These components include use of cueing strategies, training of muscle power and balance and focusing of attention on movement strategies.
The benefit of many forms of dance have being investigated in people with Parkinson's disease including Tango, (Hackney et al 2007), Contact Improvisation (Marchant et al 2010) and modern dance (Batson 2010). However, recently Irish set dancing has also being found to be beneficial for those with Parkinson's disease (Volpe et al 2013). Irish Set dancing may be beneficial for people with Parkinson's disease as it involves continuous movement initiation and cessation along with focusing of attention on body posture and foot placement. However, research to date has not been conducted in the Irish population. It is important to investigate if set dancing is beneficial for people with Parkinson's disease in Ireland as results may be influenced by the familiarity which the Irish population has for set dancing.
The objectives of the study are:
- To compare functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease before and after participating in set dancing classes, using the following validated outcome measures: Unified Parkinson's Disease Rating Scale 3, Berg Balance Scale, The Parkinson's Disease Questionnaire and The Six-Minute Walk Test.
- To compare functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease participating in set dancing classes to those receiving usual care.
- To assess the effect of the intervention on care giver burden using the Zarit Care Giver Burden Interview.
Participants, who meet inclusion/exclusion criteria, will be randomly assigned to a group who will receive a set dancing intervention along with their usual care or to a control group who will continue with their usual care only. Participants will be assessed the week before the intervention period begins and the week after the intervention period ends using valid and reliable outcome measures.
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
- Double (Investigator, 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 Hoeln and Yahr scale for staging of Parkinson's disease (Batson 2010)
- •Showing a clear benefit from anti-Parkinson medication (Marchant et al 2010)
- •Able to walk three meters with or without an assistive device (Hackney and Earhart 2009)
- •Not pregnant
- •Over 18 year of age
- •Have a TV and DVD player in their own home 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 contraindicating participation in exercise participation(Duncan and Earhart 2012)
- •A cognitive or hearing problem which will effect 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)
研究组 & 干预措施
Intervention group
Participants in this group will receive a set dancing intervention along with their usual care.
干预措施: Intervention group (Other)
Control Group
The control group will continue with their usual medical regime, activities of daily living and exercise habits and at the end of the study participants in this group will be offered the set dancing intervention.
结局指标
主要结局
Berg Balance Scale (To assess change in balance)
时间窗: This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.
The aim of the Berg Balance Scale is to assess functional balance (Marigold and Eng 2006). The measure consists of 14 items. Each item requires the participant to perform a functional balance task such as turning, stepping and reaching (Marigold and Eng 2006). A lower score is indicative of compromised balance performance. This measure is a valid and reliable measure and has being found to correlate with UPDRS scores and Hoeln and Yahr scale for staging of Parkinson's disease (Qutubuddin et al 2005).
次要结局
- Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)(This outcome will be assessed the week before the intervention begins and 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 the week before the intervention begins and the week after the intervention period ends.)
- Six-Minute Walk Test (To assess change of functional exercise tolerance)(This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.)
- Zarit Care Giver Burden Interview (ZCBI)(To assess changes in caregiver burden)(This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.)
研究者
Joanne Shanahan
Joanne Shanahan, B.S.c, MISCP
University of Limerick