- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134506
Dance in Parkinson's Disease. A Greek Pilot Study
Effects of a Structured Dance Program in Parkinson's Disease. A Greek Pilot Study
Dance for Parkinson's Disease® (DfPD®) is a structured dance program that has never been evaluated in Greek PD population. This study assesses for the first time the efficacy, safety and feasibility of DfPD® program in Greek PD patients.
A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parkinson's Disease (PD) is an idiopathic, neurodegenerative, and progressive movement disorder caused mainly by dysfunction of dopaminergic cells of the substantia nigra. Numerous studies demonstrate the benefits of regular physical exercise in PD, with aerobic exercise having a greater neuroprotective effect by stimulating brain neuroplasticity. People with PD are more easily motivated to attend dance classes systematically than other forms of exercise, they have a high compliance rate with low dropouts, and often continue to practice dance outside the dance intervention.
DfPD® (Dance for Parkinson's Disease®, or Dance for PD®) was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001.This intervention has previously been shown to exert beneficial effect on QoL, motor functions, cognition, self-efficacy, anxiety and depression in people with PD. To the investigators' knowledge, there is no study investigating the effect of any structured dance program in Greek PD patients. Furthermore, no study to date has investigated the effect of DfPD® on PD patients' fatigue. The present pilot study aimed at evaluating for the first time the efficacy, safety and feasibility of a culturally adjusted DfPD® program in Greek patients with early-to-mid-stage PD.
This is a prospective, non-randomized, uncontrolled, open-label, pilot study. A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Attica
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Athens, Attica, Greece, 12243
- Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥18 years
- An established diagnosis of idiopathic PD of an early-to-moderate severity; that is from 0 to 2,5 according to Hoehn and Yahr (H&Y) stages
- Ability to understand, write and speak in Greek
- Written consent for participating into the study
Exclusion Criteria:
- A diagnosis of a non-PD tremor disorder
- Moderate-to-severe PD (≥3 H&Y stages) due to a high falls risk
- Serious health or disability issues (either physical or mental) due of which exercise is not permitted and/or basic instructions during the program cannot be followed
- Mental disorder not related to PD
- Any disease other than PD which could affect mobility levels
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dance for PD® classes
Dance for PD® was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001.
It was designed to introduce people with PD to techniques used by dancers to control movement and it integrates different dance genres while participants dance individually and in groups rather than partnered.
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The intervention consisted of 16 60-min classes, performed twice weekly over a period of 8 weeks and instructed by a single researcher who had the approval to use it for research reasons.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total score of Parkinson's Disease Questionnaire-8
Time Frame: Baseline (week 1), end of intervention (week 10)
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Minimum score 0, Maximum score 100.
A higher score indicates worse quality of life.
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Baseline (week 1), end of intervention (week 10)
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Occurence of Emergent Adverse Events
Time Frame: During the intervention (week 2-9)
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Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
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During the intervention (week 2-9)
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Financial Feasibility Assessment
Time Frame: During the intervention (week 2-9)
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No cost for the studio and the dance instructor.
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During the intervention (week 2-9)
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Adherence and Attrition Assessment
Time Frame: During the intervention (week 2-9)
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Adherence and attrition rates; an adherence rate ≥70% is considered as high in elderly with functional limitations, and attrition rate ≤15% is considered acceptable by the PEDro scale.
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During the intervention (week 2-9)
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Assessment of Willingness to Continue the Program after the Intervention
Time Frame: End of intervention (week 10)
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Verbal statement for continuing the program after the end of the intervention
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End of intervention (week 10)
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Assessment of Recruitment Rates
Time Frame: Start of Recruitment (-3 months), Baseline (week 1)
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Target, up to 2 months for 16 participants.
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Start of Recruitment (-3 months), Baseline (week 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total score of Beck Depression Inventory-II
Time Frame: Baseline (week 1), end of intervention (week 10)
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Minimum score 0, Maximum score 63.
A higher score indicates worse depressive symptoms.
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Baseline (week 1), end of intervention (week 10)
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Change in total score of Parkinson Fatigue Scale-16
Time Frame: Baseline (week 1), end of intervention (week 10)
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Minimum score 1, Maximum score 5.
A higher score indicates more fatigue.
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Baseline (week 1), end of intervention (week 10)
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Change in total score of Montreal Cognitive Assessment
Time Frame: Baseline (week 1), end of intervention (week 10)
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Minimum score is 0, Maximum score 30.
Lower scores indicate cognitive impairment.
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Baseline (week 1), end of intervention (week 10)
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Change in total score of Berg Balance Scale
Time Frame: Baseline (week 1), end of intervention (week 10)
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Minimum score is 0, Maximum score is 56.
Lower scores indicate worse balance.
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Baseline (week 1), end of intervention (week 10)
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Change in Body Mass Index
Time Frame: Baseline (week 1), end of intervention (week 10)
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Lower scores than 18,5 indicate underweight, scores of 18,5-24,9 indicate normal weight, scores of 25-29,9 indicate overweight and scores of over 30 indicate obesity.
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Baseline (week 1), end of intervention (week 10)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michail Elpidoforou, MSc, Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- 296/24.4.2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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