A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Dance group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dance group<br>Participants allocated to this group will continue with their usual care and participate in a set dancing class. | Other: Dance group<br>* Participants will attend ten weeks of set dancing classes. Each class will be one and half hours. Family members will be invited to partner each participant with Parkinson's disease during the class. Set dancing steps and sets will be thought and progressed in line with the participants abilities. Frequent rests will be taken during the classes. Participants will be given a home exercise programme which will involve chair based exercises, mental rehearsal, listening music, watching a dance DVD and practicing dance material thought in class.<br>|
| No Intervention: Control group<br>Participants allocated to this group will act as a control group and continue to receive their usual care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of randomization procedures (To assess implementation of randomization procedures) |  | This outcome measure will be assessed over a 1 year period from study inception to completion | 
| Attrition (To assess dropout rate during the study) | Attrition rate of ≤ 20% per group will be deemed acceptable | This outcome measure will be assessed over a 1 year period from study inception to completion | 
| Intervention adherence (To assess compliance with the dance intervention) | 2) Intervention will be considered successful if no adverse effects or safety issues are reported and attendance at classes is ≥70% | This outcome will be assessed during the 10 week set dancing intervention | 
| Recruitment rates (To assess rate, duration and success of recruitment methods) | Recruitment considered successful and feasible is 100 participants are recruited in one year | This outcome will be assessed over a one year recruitment period | 
| Resources (To assess availability of personnel and building needed to implement study methodology) | Document issues regarding availability of personnel or buildings needed to implement study methodology | This outcome measure will be assessed over a 1 year period from study inception to completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exit Questionnaire (To assess participants satisfaction) | The exit questionnaire will assess participants' satisfaction with the dance intervention at the end of the study. The questionnaire asks participants if they have noted improvements in different aspects of physical well-being, and allows feedback relating to the structure, material and enjoyment of the dance classes to be gathered. This questionnaire has previously been used in other studies investigating the benefit of dance for those with Parkinson's disease (Hackney and Earhart 2009; Hackney and Earhart 2010). | 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) | Self-report quality of life questionnaire | This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends | 
| Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment) | Disease specific measure of motor function | 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) | Measure of functional endurance | 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) | Balance measure | This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Irish set dancing