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Impact of Dance Therapy on Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ballroom Dancing Classes
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson, ballroom dancing

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years and older, both males and females, all races and all ethnicities
  • Idiopathic Parkinson's disease diagnosed using United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
  • Mild to moderate disease severity (Stage 2 to 3 on the Modified Hoehn and Yahr scale)
  • Stable medication regimen for a minimum of 1 month before testing
  • Ability to ambulate independently without using a walking aid
  • Ability to give informed consent

Exclusion Criteria:

  • Prior enrollment in a dancing class during the last 6 months
  • Presence of another neurological or medical disorder likely to affect gait or causing frequent falls (rheumatologic/orthopedic disease, stroke, myelopathy, severe neuropathy)
  • Significant cognitive decline (MMSE ≤ 24)
  • Visual deficit
  • Hearing deficit that impairs music perception
  • Psychotic symptoms
  • Symptomatic heart disease
  • Depression associated with suicidal ideation

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intervention

control

Arm Description

group of patients receiving ballroom dancing classes

group of patients who will not receive dancing classes.

Outcomes

Primary Outcome Measures

Effect of ballroom dancing classes on motor function in patients with Parkinson's disease.
The improvement in participant's motor function will be measured by the UPRS III score. The aim is to detect an 18-20% difference in UPDRS III scores among the two groups.

Secondary Outcome Measures

Effect of ballroom dancing classes on depression in patients with Parkinson's disease.
The improvement in participant's depression will be measured by the Hamilton Depression Scale.
Effect of ballroom dancing classes on quality of life of patients with Parkinson's disease.
The improvement in participant's quality of life will be measured by the Parkinson's Disease-39 questionnaire PDQ-39 scale.

Full Information

First Posted
September 2, 2011
Last Updated
March 3, 2015
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT01428648
Brief Title
Impact of Dance Therapy on Parkinson's Disease
Official Title
Impact of Dance Therapy on Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment slow
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor tasks, affects quality of life and has been associated with depression. The purpose of this study is to investigate the effect of dance therapy on motor performance, quality of life and depression in PD patients, by comparing certain symptoms between a group of subjects with PD who undergo ballroom dancing classes and a control group of subjects with PD. The investigators will assess mental status, severity of PD, quality of life and depression using rating scales. Subjects will be randomized to intervention and control group. Intervention group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks. Control group will be examined at same time intervals. Classes will follow a curriculum designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant risk for participants.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Active Comparator
Arm Description
group of patients receiving ballroom dancing classes
Arm Title
control
Arm Type
No Intervention
Arm Description
group of patients who will not receive dancing classes.
Intervention Type
Behavioral
Intervention Name(s)
Ballroom Dancing Classes
Intervention Description
bi-weekly, 12-Week ballroom dance classes
Primary Outcome Measure Information:
Title
Effect of ballroom dancing classes on motor function in patients with Parkinson's disease.
Description
The improvement in participant's motor function will be measured by the UPRS III score. The aim is to detect an 18-20% difference in UPDRS III scores among the two groups.
Time Frame
3 and 5 months
Secondary Outcome Measure Information:
Title
Effect of ballroom dancing classes on depression in patients with Parkinson's disease.
Description
The improvement in participant's depression will be measured by the Hamilton Depression Scale.
Time Frame
3 and 5 months
Title
Effect of ballroom dancing classes on quality of life of patients with Parkinson's disease.
Description
The improvement in participant's quality of life will be measured by the Parkinson's Disease-39 questionnaire PDQ-39 scale.
Time Frame
3 and 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older, both males and females, all races and all ethnicities Idiopathic Parkinson's disease diagnosed using United Kingdom Parkinson's Disease Society brain bank diagnostic criteria Mild to moderate disease severity (Stage 2 to 3 on the Modified Hoehn and Yahr scale) Stable medication regimen for a minimum of 1 month before testing Ability to ambulate independently without using a walking aid Ability to give informed consent Exclusion Criteria: Prior enrollment in a dancing class during the last 6 months Presence of another neurological or medical disorder likely to affect gait or causing frequent falls (rheumatologic/orthopedic disease, stroke, myelopathy, severe neuropathy) Significant cognitive decline (MMSE ≤ 24) Visual deficit Hearing deficit that impairs music perception Psychotic symptoms Symptomatic heart disease Depression associated with suicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Maalouf, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9923759
Citation
Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.
Results Reference
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PubMed Identifier
19711119
Citation
Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.
Results Reference
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PubMed Identifier
21461962
Citation
Ransmayr G. Physical, occupational, speech and swallowing therapies and physical exercise in Parkinson's disease. J Neural Transm (Vienna). 2011 May;118(5):773-81. doi: 10.1007/s00702-011-0622-9. Epub 2011 Apr 3.
Results Reference
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PubMed Identifier
8264910
Citation
Ellgring H, Seiler S, Perleth B, Frings W, Gasser T, Oertel W. Psychosocial aspects of Parkinson's disease. Neurology. 1993 Dec;43(12 Suppl 6):S41-4.
Results Reference
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PubMed Identifier
19691125
Citation
Barichella M, Cereda E, Pezzoli G. Major nutritional issues in the management of Parkinson's disease. Mov Disord. 2009 Oct 15;24(13):1881-92. doi: 10.1002/mds.22705.
Results Reference
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PubMed Identifier
21426462
Citation
Joanna Briggs Institute. The Joanna Briggs Institute Best Practice Information Sheet: music as an intervention in hospitals. Nurs Health Sci. 2011 Mar;13(1):99-102. doi: 10.1111/j.1442-2018.2011.00583.x.
Results Reference
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PubMed Identifier
8544252
Citation
Marwick C. Leaving concert hall for clinic, therapists now test music's 'charms'. JAMA. 1996 Jan 24-31;275(4):267-8. No abstract available.
Results Reference
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PubMed Identifier
21154376
Citation
Bradt J, Dileo C, Grocke D. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006902. doi: 10.1002/14651858.CD006902.pub2.
Results Reference
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PubMed Identifier
18395022
Citation
Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
Results Reference
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PubMed Identifier
8902026
Citation
Glover H, Kalinowski J, Rastatter M, Stuart A. Effect of instruction to sing on stuttering frequency at normal and fast rates. Percept Mot Skills. 1996 Oct;83(2):511-22. doi: 10.2466/pms.1996.83.2.511.
Results Reference
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Impact of Dance Therapy on Parkinson's Disease

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