Dance in Parkinson's Disease. A Greek Pilot Study

Sponsor

University of West Attica (Other)

Overall Status

Completed

CT.gov ID

NCT05134506

Collaborator

(none)

Enrollment

Location

Arm

2.1

Actual Duration (Months)

7.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Dance for PD® classes	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 28, 2019

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dance for PD® classes 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 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.

Arm

Intervention/Treatment

Experimental: Dance for PD® classes

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

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.

Outcome Measures

Primary Outcome Measures

Change in total score of Parkinson's Disease Questionnaire-8 [Baseline (week 1), end of intervention (week 10)]
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Occurence of Emergent Adverse Events [During the intervention (week 2-9)]
Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
Financial Feasibility Assessment [During the intervention (week 2-9)]
No cost for the studio and the dance instructor.
Adherence and Attrition Assessment [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.
Assessment of Willingness to Continue the Program after the Intervention [End of intervention (week 10)]
Verbal statement for continuing the program after the end of the intervention
Assessment of Recruitment Rates [Start of Recruitment (-3 months), Baseline (week 1)]
Target, up to 2 months for 16 participants.

Secondary Outcome Measures

Change in total score of Beck Depression Inventory-II [Baseline (week 1), end of intervention (week 10)]
Minimum score 0, Maximum score 63. A higher score indicates worse depressive symptoms.
Change in total score of Parkinson Fatigue Scale-16 [Baseline (week 1), end of intervention (week 10)]
Minimum score 1, Maximum score 5. A higher score indicates more fatigue.
Change in total score of Montreal Cognitive Assessment [Baseline (week 1), end of intervention (week 10)]
Minimum score is 0, Maximum score 30. Lower scores indicate cognitive impairment.
Change in total score of Berg Balance Scale [Baseline (week 1), end of intervention (week 10)]
Minimum score is 0, Maximum score is 56. Lower scores indicate worse balance.
Change in Body Mass Index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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