Dance in Parkinson's Disease. A Greek Pilot Study

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134506
• Other study ID #: 296/24.4.2019
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: November 2021
• Source: University of West Attica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Dance for PD® classes
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.

Locations

Country	Name	City	State
Greece	Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
University of West Attica

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Occurence of Emergent Adverse Events	Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.	During the intervention (week 2-9)
Primary	Financial Feasibility Assessment	No cost for the studio and the dance instructor.	During the intervention (week 2-9)
Primary	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)
Primary	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)
Primary	Assessment of Recruitment Rates	Target, up to 2 months for 16 participants.	Start of Recruitment (-3 months), Baseline (week 1)
Secondary	Change in total score of Beck Depression Inventory-II	Minimum score 0, Maximum score 63. A higher score indicates worse depressive symptoms.	Baseline (week 1), end of intervention (week 10)
Secondary	Change in total score of Parkinson Fatigue Scale-16	Minimum score 1, Maximum score 5. A higher score indicates more fatigue.	Baseline (week 1), end of intervention (week 10)
Secondary	Change in total score of Montreal Cognitive Assessment	Minimum score is 0, Maximum score 30. Lower scores indicate cognitive impairment.	Baseline (week 1), end of intervention (week 10)
Secondary	Change in total score of Berg Balance Scale	Minimum score is 0, Maximum score is 56. Lower scores indicate worse balance.	Baseline (week 1), end of intervention (week 10)
Secondary	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.	Baseline (week 1), end of intervention (week 10)