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Dance in Parkinson's Disease. A Greek Pilot Study

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dance for PD® classes
Sponsored by
University of West Attica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Dance, Dance for Parkinson's, Quality of Life, Depression, Fatigue, Cognitive Functions

Eligibility Criteria

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

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

Sites / Locations

  • Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dance for PD® classes

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in total score of Parkinson's Disease Questionnaire-8
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Occurence of Emergent Adverse Events
Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
Financial Feasibility Assessment
No cost for the studio and the dance instructor.
Adherence and Attrition Assessment
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.
Assessment of Willingness to Continue the Program after the Intervention
Verbal statement for continuing the program after the end of the intervention
Assessment of Recruitment Rates
Target, up to 2 months for 16 participants.

Secondary Outcome Measures

Change in total score of Beck Depression Inventory-II
Minimum score 0, Maximum score 63. A higher score indicates worse depressive symptoms.
Change in total score of Parkinson Fatigue Scale-16
Minimum score 1, Maximum score 5. A higher score indicates more fatigue.
Change in total score of Montreal Cognitive Assessment
Minimum score is 0, Maximum score 30. Lower scores indicate cognitive impairment.
Change in total score of Berg Balance Scale
Minimum score is 0, Maximum score is 56. Lower scores indicate worse balance.
Change in Body Mass Index
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.

Full Information

First Posted
October 16, 2021
Last Updated
November 14, 2021
Sponsor
University of West Attica
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1. Study Identification

Unique Protocol Identification Number
NCT05134506
Brief Title
Dance in Parkinson's Disease. A Greek Pilot Study
Official Title
Effects of a Structured Dance Program in Parkinson's Disease. A Greek Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Dance, Dance for Parkinson's, Quality of Life, Depression, Fatigue, Cognitive Functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance for PD® classes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dance for PD® classes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total score of Parkinson's Disease Questionnaire-8
Description
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Time Frame
Baseline (week 1), end of intervention (week 10)
Title
Occurence of Emergent Adverse Events
Description
Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
Time Frame
During the intervention (week 2-9)
Title
Financial Feasibility Assessment
Description
No cost for the studio and the dance instructor.
Time Frame
During the intervention (week 2-9)
Title
Adherence and Attrition Assessment
Description
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.
Time Frame
During the intervention (week 2-9)
Title
Assessment of Willingness to Continue the Program after the Intervention
Description
Verbal statement for continuing the program after the end of the intervention
Time Frame
End of intervention (week 10)
Title
Assessment of Recruitment Rates
Description
Target, up to 2 months for 16 participants.
Time Frame
Start of Recruitment (-3 months), Baseline (week 1)
Secondary Outcome Measure Information:
Title
Change in total score of Beck Depression Inventory-II
Description
Minimum score 0, Maximum score 63. A higher score indicates worse depressive symptoms.
Time Frame
Baseline (week 1), end of intervention (week 10)
Title
Change in total score of Parkinson Fatigue Scale-16
Description
Minimum score 1, Maximum score 5. A higher score indicates more fatigue.
Time Frame
Baseline (week 1), end of intervention (week 10)
Title
Change in total score of Montreal Cognitive Assessment
Description
Minimum score is 0, Maximum score 30. Lower scores indicate cognitive impairment.
Time Frame
Baseline (week 1), end of intervention (week 10)
Title
Change in total score of Berg Balance Scale
Description
Minimum score is 0, Maximum score is 56. Lower scores indicate worse balance.
Time Frame
Baseline (week 1), end of intervention (week 10)
Title
Change in Body Mass Index
Description
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.
Time Frame
Baseline (week 1), end of intervention (week 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michail Elpidoforou, MSc
Organizational Affiliation
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
City
Athens
State/Province
Attica
ZIP/Postal Code
12243
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Dance in Parkinson's Disease. A Greek Pilot Study

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