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

Not Applicable
Completed
Conditions
Parkinson's Disease
Interventions
Other: Dance group
Registration Number
NCT01939717
Lead Sponsor
University of Limerick
Brief Summary

Primary aim is to conduct a pilot trial to determine:

1. The feasibility and efficiency of randomisation procedures and study design

2. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dance groupDance groupParticipants allocated to this group will continue with their usual care and participate in a set dancing class.
Primary Outcome Measures
NameTimeMethod
Intervention adherence (To assess compliance with the dance intervention)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%

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)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)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)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

Secondary Outcome Measures
NameTimeMethod
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

Disease specific measure of motor function

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

Measure of functional endurance

Exit Questionnaire (To assess participants satisfaction)This outcome will be assessed the week after the intervention period ends.

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).

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

Self-report quality of life questionnaire

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

Balance measure

Trial Locations

Locations (1)

University of Limerick

🇮🇪

Limerick, Munster, Ireland

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