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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Dance group
Sponsored by
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Irish set dancing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Limerick

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Dance group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility of randomization procedures (To assess implementation of randomization procedures)
Attrition (To assess dropout rate during the study)
Attrition rate of ≤ 20% per group will be deemed acceptable
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%
Recruitment rates (To assess rate, duration and success of recruitment methods)
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)
Document issues regarding availability of personnel or buildings needed to implement study methodology

Secondary Outcome Measures

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).
The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life)
Self-report quality of life questionnaire
Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)
Disease specific measure of motor function
Six minute walk test (To assess change in functional endurnace)
Measure of functional endurance
MiniBESTest (To asses change in balance)
Balance measure

Full Information

First Posted
August 25, 2013
Last Updated
May 30, 2016
Sponsor
University of Limerick
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1. Study Identification

Unique Protocol Identification Number
NCT01939717
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Limerick

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary aim is to conduct a pilot trial to determine: The feasibility and efficiency of randomisation procedures and study design 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Irish set dancing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance group
Arm Type
Other
Arm Description
Participants allocated to this group will continue with their usual care and participate in a set dancing class.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants allocated to this group will act as a control group and continue to receive their usual care only.
Intervention Type
Other
Intervention Name(s)
Dance group
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Attrition (To assess dropout rate during the study)
Description
Attrition rate of ≤ 20% per group will be deemed acceptable
Time Frame
This outcome measure will be assessed over a 1 year period from study inception to completion
Title
Intervention adherence (To assess compliance with the dance intervention)
Description
2) Intervention will be considered successful if no adverse effects or safety issues are reported and attendance at classes is ≥70%
Time Frame
This outcome will be assessed during the 10 week set dancing intervention
Title
Recruitment rates (To assess rate, duration and success of recruitment methods)
Description
Recruitment considered successful and feasible is 100 participants are recruited in one year
Time Frame
This outcome will be assessed over a one year recruitment period
Title
Resources (To assess availability of personnel and building needed to implement study methodology)
Description
Document issues regarding availability of personnel or buildings needed to implement study methodology
Time Frame
This outcome measure will be assessed over a 1 year period from study inception to completion
Secondary Outcome Measure Information:
Title
Exit Questionnaire (To assess participants satisfaction)
Description
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).
Time Frame
This outcome will be assessed the week after the intervention period ends.
Title
The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life)
Description
Self-report quality of life questionnaire
Time Frame
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
Title
Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)
Description
Disease specific measure of motor function
Time Frame
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
Title
Six minute walk test (To assess change in functional endurnace)
Description
Measure of functional endurance
Time Frame
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
Title
MiniBESTest (To asses change in balance)
Description
Balance measure
Time Frame
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meg E Morris, Prof.
Organizational Affiliation
Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Limerick
City
Limerick
State/Province
Munster
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21959675
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.
Results Reference
background
PubMed Identifier
22013420
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.
Results Reference
background
PubMed Identifier
21056841
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.
Results Reference
background
PubMed Identifier
28336345
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.
Results Reference
derived
PubMed Identifier
25557584
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.
Results Reference
derived

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

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