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Completed

NCT Number: NCT05134506

Dance 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

Athens, Attica, 12243, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dance for PD® classes

Behavioral

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 outcomes

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

    Time frame: Baseline (week 1), end of intervention (week 10)

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

  2. Occurence of Emergent Adverse Events

    Time frame: During the intervention (week 2-9)

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

  3. Financial Feasibility Assessment

    Time frame: During the intervention (week 2-9)

    No cost for the studio and the dance instructor.

  4. Adherence and Attrition Assessment

    Time frame: During the intervention (week 2-9)

    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.

  5. Assessment of Willingness to Continue the Program after the Intervention

    Time frame: End of intervention (week 10)

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

  6. Assessment of Recruitment Rates

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

    Target, up to 2 months for 16 participants.

Secondary outcomes

  1. Change in total score of Beck Depression Inventory-II

    Time frame: Baseline (week 1), end of intervention (week 10)

    Minimum score 0, Maximum score 63. A higher score indicates worse depressive symptoms.

  2. Change in total score of Parkinson Fatigue Scale-16

    Time frame: Baseline (week 1), end of intervention (week 10)

    Minimum score 1, Maximum score 5. A higher score indicates more fatigue.

  3. Change in total score of Montreal Cognitive Assessment

    Time frame: Baseline (week 1), end of intervention (week 10)

    Minimum score is 0, Maximum score 30. Lower scores indicate cognitive impairment.

  4. Change in total score of Berg Balance Scale

    Time frame: Baseline (week 1), end of intervention (week 10)

    Minimum score is 0, Maximum score is 56. Lower scores indicate worse balance.

  5. Change in Body Mass Index

    Time frame: Baseline (week 1), end of intervention (week 10)

    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.

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

Effects of a Structured Dance Program in Parkinson's Disease. A Greek Pilot Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2021
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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