Clinical trial NCT05134506: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Dance
Dance for Parkinson's
Quality of Life
Depression
Fatigue
Cognitive Functions
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in total score of Parkinson's Disease Questionnaire-8
timeFrame: Baseline (week 1), end of intervention (week 10)
measure: Occurence of Emergent Adverse Events
timeFrame: During the intervention (week 2-9)
measure: Financial Feasibility Assessment
timeFrame: During the intervention (week 2-9)
measure: Adherence and Attrition Assessment
timeFrame: During the intervention (week 2-9)
measure: Assessment of Willingness to Continue the Program after the Intervention
timeFrame: End of intervention (week 10)
measure: Assessment of Recruitment Rates
timeFrame: Start of Recruitment (-3 months), Baseline (week 1)
Secondary outcomes:
measure: Change in total score of Beck Depression Inventory-II
timeFrame: Baseline (week 1), end of intervention (week 10)
measure: Change in total score of Parkinson Fatigue Scale-16
timeFrame: Baseline (week 1), end of intervention (week 10)
measure: Change in total score of Montreal Cognitive Assessment
timeFrame: Baseline (week 1), end of intervention (week 10)
measure: Change in total score of Berg Balance Scale
timeFrame: Baseline (week 1), end of intervention (week 10)
measure: Change in Body Mass Index
timeFrame: Baseline (week 1), end of intervention (week 10)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
state: Attica
Study officials:
affiliation: Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
name: Michail Elpidoforou, MSc
role: PRINCIPAL_INVESTIGATOR
References: