Clinical trial NCT01939717: A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease
Official title: A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Irish set dancing
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Feasibility of randomization procedures (To assess implementation of randomization procedures)
timeFrame: This outcome measure will be assessed over a 1 year period from study inception to completion
measure: Attrition (To assess dropout rate during the study)
timeFrame: This outcome measure will be assessed over a 1 year period from study inception to completion
measure: Intervention adherence (To assess compliance with the dance intervention)
timeFrame: This outcome will be assessed during the 10 week set dancing intervention
measure: Recruitment rates (To assess rate, duration and success of recruitment methods)
timeFrame: This outcome will be assessed over a one year recruitment period
measure: Resources (To assess availability of personnel and building needed to implement study methodology)
timeFrame: This outcome measure will be assessed over a 1 year period from study inception to completion
Secondary outcomes:
measure: Exit Questionnaire (To assess participants satisfaction)
timeFrame: This outcome will be assessed the week after the intervention period ends.
measure: The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life)
timeFrame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
measure: Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)
timeFrame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
measure: Six minute walk test (To assess change in functional endurnace)
timeFrame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
measure: MiniBESTest (To asses change in balance)
timeFrame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
state: Munster
Study officials:
affiliation: Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia.
name: Meg E Morris, Prof.
role: STUDY_CHAIR
References:
citation: Duncan RP, Earhart GM. Randomized controlled trial of community-based dancing to modify disease progression in Parkinson disease. Neurorehabil Neural Repair. 2012 Feb;26(2):132-43. doi: 10.1177/1545968311421614. Epub 2011 Sep 29.
citation: Heiberger L, Maurer C, Amtage F, Mendez-Balbuena I, Schulte-Monting J, Hepp-Reymond MC, Kristeva R. Impact of a weekly dance class on the functional mobility and on the quality of life of individuals with Parkinson's disease. Front Aging Neurosci. 2011 Oct 10;3:14. doi: 10.3389/fnagi.2011.00014. eCollection 2011.
citation: Marchant D, Sylvester JL, Earhart GM. Effects of a short duration, high dose contact improvisation dance workshop on Parkinson disease: a pilot study. Complement Ther Med. 2010 Oct;18(5):184-90. doi: 10.1016/j.ctim.2010.07.004. Epub 2010 Aug 21.
citation: Shanahan J, Morris ME, Bhriain ON, Volpe D, Lynch T, Clifford AM. Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care. Arch Phys Med Rehabil. 2017 Sep;98(9):1744-1751. doi: 10.1016/j.apmr.2017.02.017. Epub 2017 Mar 21.
citation: Shanahan J, Morris ME, Bhriain ON, Volpe D, Richardson M, Clifford AM. Is Irish set dancing feasible for people with Parkinson's disease in Ireland? Complement Ther Clin Pract. 2015 Feb;21(1):47-51. doi: 10.1016/j.ctcp.2014.12.002. Epub 2014 Dec 13.