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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939717
• Other study ID #: ST2
• Status: Completed
• Phase: N/A
• First received: August 25, 2013
• Last updated: May 30, 2016
• Start date: August 2013
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Dance group
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.

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick	Munster

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View Citation

Heiberger L, Maurer C, Amtage F, Mendez-Balbuena I, Schulte-Mönting 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No