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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2016
• Main ID: NCT01939717
• Date of registration: 25/08/2013
• Prospective Registration: No
• Primary sponsor: University of Limerick
• Public title: A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease
• Scientific title: A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease
• Date of first enrolment: August 2013
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01939717
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Meg E Morris, Prof.
• Affiliation: Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia.

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: Dance group

Primary Outcome(s)

Feasibility of randomization procedures (To assess implementation of randomization procedures) [Time Frame: This outcome measure will be assessed over a 1 year period from study inception to completion]

Attrition (To assess dropout rate during the study) [Time Frame: This outcome measure will be assessed over a 1 year period from study inception to completion]

Recruitment rates (To assess rate, duration and success of recruitment methods) [Time Frame: This outcome will be assessed over a one year recruitment period]

Resources (To assess availability of personnel and building needed to implement study methodology) [Time Frame: 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) [Time Frame: This outcome will be assessed during the 10 week set dancing intervention]

Secondary Outcome(s)

MiniBESTest (To asses change in balance) [Time Frame: 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) [Time Frame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends]

The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life) [Time Frame: 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) [Time Frame: 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) [Time Frame: This outcome will be assessed the week after the intervention period ends.]

Secondary ID(s)

ST2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors