NCT01428648

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

September 2, 2011

Last Update Submit

March 3, 2015

Conditions

Parkinson's Disease

Keywords

Parkinsonballroom dancing

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 and 5 months

Secondary Outcomes (2)

  • Effect of ballroom dancing classes on depression in patients with Parkinson's disease.

    3 and 5 months

  • Effect of ballroom dancing classes on quality of life of patients with Parkinson's disease.

    3 and 5 months

Study Arms (2)

intervention

ACTIVE COMPARATOR

group of patients receiving ballroom dancing classes

Behavioral: Ballroom Dancing Classes

control

NO INTERVENTION

group of patients who will not receive dancing classes.

Interventions

Ballroom Dancing ClassesBEHAVIORAL

bi-weekly, 12-Week ballroom dance classes

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (10)

  • 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.

    PMID: 9923759BACKGROUND

  • 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.

    PMID: 19711119BACKGROUND

  • 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.

    PMID: 21461962BACKGROUND

  • 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.

    PMID: 8264910BACKGROUND

  • 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.

    PMID: 19691125BACKGROUND

  • 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.

    PMID: 21426462BACKGROUND

  • 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.

    PMID: 8544252BACKGROUND

  • 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.

    PMID: 21154376BACKGROUND

  • 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.

    PMID: 18395022BACKGROUND

  • 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.

    PMID: 8902026BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nancy Maalouf, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 5, 2011

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

US(1)