- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388556
PD4PD:Partnered Dance for Parkinson Disease (PD4PD)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63108
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
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Experimental: Tango
Twice weekly tango dance classes for 12 months.
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Twice weekly tango dance classes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Symptom Severity
Time Frame: 12 months
|
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.
|
12 months
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD4PD-09-0168
- PDF (Other Grant/Funding Number: Parkinson's Disease Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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