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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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ClinicalTrials.gov Identifier: NCT01939717
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Joanne Shanahan, University of Limerick

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Dance group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease
Study Start Date : August 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Dance group
Participants allocated to this group will continue with their usual care and participate in a set dancing class.
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.


No Intervention: Control group
Participants allocated to this group will act as a control group and continue to receive their usual care only.



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
    Attrition rate of ≤ 20% per group will be deemed acceptable

  3. Intervention adherence (To assess compliance with the dance intervention) [ Time Frame: This outcome will be assessed during the 10 week set dancing intervention ]
    2) Intervention will be considered successful if no adverse effects or safety issues are reported and attendance at classes is ≥70%

  4. Recruitment rates (To assess rate, duration and success of recruitment methods) [ Time Frame: This outcome will be assessed over a one year recruitment period ]
    Recruitment considered successful and feasible is 100 participants are recruited in one year

  5. 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 ]
    Document issues regarding availability of personnel or buildings needed to implement study methodology


Secondary Outcome Measures :
  1. Exit Questionnaire (To assess participants satisfaction) [ Time Frame: This outcome will be assessed the week after the intervention period ends. ]
    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).

  2. 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 ]
    Self-report quality of life questionnaire

  3. 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 ]
    Disease specific measure of motor function

  4. 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 ]
    Measure of functional endurance

  5. 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 ]
    Balance measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939717


Locations
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Ireland
University of Limerick
Limerick, Munster, Ireland
Sponsors and Collaborators
University of Limerick
Investigators
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Study Chair: Meg E Morris, Prof. Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joanne Shanahan, Joanne Shanahan, B.S.c, MISCP, University of Limerick
ClinicalTrials.gov Identifier: NCT01939717     History of Changes
Other Study ID Numbers: ST2
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by Joanne Shanahan, University of Limerick:
Parkinson's disease
Irish set dancing

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases