NCT05134506

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 28, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

October 16, 2021

Last Update Submit

November 14, 2021

Conditions

Keywords

Parkinson's DiseaseDanceDance for Parkinson'sQuality of LifeDepressionFatigueCognitive Functions

Outcome Measures

Primary Outcomes (6)

  • Change in total score of Parkinson's Disease Questionnaire-8

    Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.

    Baseline (week 1), end of intervention (week 10)

  • Occurence of Emergent Adverse Events

    Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.

    During the intervention (week 2-9)

  • Financial Feasibility Assessment

    No cost for the studio and the dance instructor.

    During the intervention (week 2-9)

  • 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.

    During the intervention (week 2-9)

  • Assessment of Willingness to Continue the Program after the Intervention

    Verbal statement for continuing the program after the end of the intervention

    End of intervention (week 10)

  • Assessment of Recruitment Rates

    Target, up to 2 months for 16 participants.

    Start of Recruitment (-3 months), Baseline (week 1)

Secondary Outcomes (5)

  • Change in total score of Beck Depression Inventory-II

    Baseline (week 1), end of intervention (week 10)

  • Change in total score of Parkinson Fatigue Scale-16

    Baseline (week 1), end of intervention (week 10)

  • Change in total score of Montreal Cognitive Assessment

    Baseline (week 1), end of intervention (week 10)

  • Change in total score of Berg Balance Scale

    Baseline (week 1), end of intervention (week 10)

  • Change in Body Mass Index

    Baseline (week 1), end of intervention (week 10)

Study Arms (1)

Dance for PD® classes

EXPERIMENTAL

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.

Behavioral: Dance for PD® classes

Interventions

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.

Dance for PD® classes

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

Athens, Attica, 12243, Greece

Location

MeSH Terms

Conditions

Parkinson DiseaseDepressionFatigue

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michail Elpidoforou, MSc

    Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2021

First Posted

November 26, 2021

Study Start

May 28, 2019

Primary Completion

July 30, 2019

Study Completion

July 31, 2019

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations