PD4PD:Partnered Dance for Parkinson Disease (PD4PD)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tango dancing
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring exercise, Parkinson disease, motor symptoms, gait, balance
Eligibility Criteria
Inclusion Criteria:
- normal central and peripheral neurological function
- at least grade 4/5 strength and normal joint ranges of motion in both legs, - vision corrected to 20/40 or better
- able to walk independently for 10 feet with or without an assistive device, - normal somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch)
- no history of vestibular disease
Exclusion Criteria:
- serious medical problem
- evidence of abnormality other than PD-related changes on brain imaging (previously done for clinical evaluations-not part of this research)
- history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease
- history or evidence of orthopedic, muscular, or psychological problem
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tango
Control Group
Arm Description
Twice weekly tango dance classes for 12 months.
Outcomes
Primary Outcome Measures
Motor Symptom Severity
We will use the Unified Parkinson Disease Rating Scale, Motor Subscale 3, to assess the severity of movement-related symptoms. This is a standanrdized and well-established tool composed of multiple items each scored on a 0-4 scale, with 0 indicating no impairment and 4 indication severe impairment. The overall severity of motor symptoms is determined by summing scores for all of the individual items.
Secondary Outcome Measures
Full Information
NCT ID
NCT01388556
First Posted
June 29, 2011
Last Updated
December 7, 2015
Sponsor
Washington University School of Medicine
Collaborators
Parkinson's Disease Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01388556
Brief Title
PD4PD:Partnered Dance for Parkinson Disease
Acronym
PD4PD
Official Title
PD4PD:Partnered Dance for Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Parkinson's Disease Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Exercise is often noted as an important component in a comprehensive approach to the management of Parkinson disease (PD). Most studies of exercise have examined the effects of short-term interventions and have tested participants on their anti-Parkinson medications. As such, these studies have not been able to determine whether or not exercise may have a disease-modifying effect in people with PD. The investigators recent work has shown the potential benefits of dance as a form of exercise for individuals with PD, but, like previous work, has only examined short-term interventions. The investigators think that dance may be ideally suited for study over a longer period of time because dance incorporates many of the features recommended for inclusion in PD-specific exercise programs in a format that is known to be engaging and to enhance motivation to participate in healthful behaviors. As such, the investigators aim to determine both the short- and long-term effectiveness of a community-based dance program for individuals with Parkinson disease and to determine how physical function changes over time in individuals with PD who do not exercise as compared to those who exercise regularly. The investigators hypothesize that:
A) participation in dance will result in improved physical function, cognitive function, mood and quality of life in people with PD within 3 months,
B) additional improvements will be noted at 6 months as compared to 3 months,
C) improvements will be maintained at one year with continued, regular participation in a dance class,
D) those who do not exercise will show significant functional decline over a period of one year, a decline that will not be present in those who dance regularly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
exercise, Parkinson disease, motor symptoms, gait, balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tango
Arm Type
Experimental
Arm Description
Twice weekly tango dance classes for 12 months.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Tango dancing
Intervention Description
Twice weekly tango dance classes
Primary Outcome Measure Information:
Title
Motor Symptom Severity
Description
We will use the Unified Parkinson Disease Rating Scale, Motor Subscale 3, to assess the severity of movement-related symptoms. This is a standanrdized and well-established tool composed of multiple items each scored on a 0-4 scale, with 0 indicating no impairment and 4 indication severe impairment. The overall severity of motor symptoms is determined by summing scores for all of the individual items.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
normal central and peripheral neurological function
at least grade 4/5 strength and normal joint ranges of motion in both legs, - vision corrected to 20/40 or better
able to walk independently for 10 feet with or without an assistive device, - normal somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch)
no history of vestibular disease
Exclusion Criteria:
serious medical problem
evidence of abnormality other than PD-related changes on brain imaging (previously done for clinical evaluations-not part of this research)
history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease
history or evidence of orthopedic, muscular, or psychological problem
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21091047
Citation
Duncan RP, Earhart GM. Measuring participation in individuals with Parkinson disease: relationships with disease severity, quality of life, and mobility. Disabil Rehabil. 2011;33(15-16):1440-6. doi: 10.3109/09638288.2010.533245. Epub 2010 Nov 20.
Results Reference
background
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PD4PD:Partnered Dance for Parkinson Disease
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