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

NCT01939717 | Completed

• 1 other identifier: ST2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aim is to conduct a pilot trial to determine:

1. 1.The feasibility and efficiency of randomisation procedures and study design
2. 2.If recruitment rates are sufficient to adequately power a larger trial

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Irish set dancing

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Exit Questionnaire (To assess participants satisfaction)

  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)

  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)

  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)

  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)

  This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

Study Arms (2)

Dance group

OTHER

Participants allocated to this group will continue with their usual care and participate in a set dancing class.

Other: Dance group

Control group

NO INTERVENTION

Participants allocated to this group will act as a control group and continue to receive their usual care only.

Interventions

Dance group OTHER

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.

Dance group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University of Limerick

Limerick, Munster, Ireland

Location

Related Publications (7)

• 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.

  PMID: 21959675 BACKGROUND

• 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.

  PMID: 22013420 BACKGROUND

• 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.

  PMID: 21056841 BACKGROUND

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• 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.

  PMID: 28336345 DERIVED

• 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.

  PMID: 25557584 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Meg E Morris, Prof.

  Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joanne Shanahan, B.S.c, MISCP

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: September 11, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

IE (1)