The UPbeating GReek Application of DancE in Parkinson's Disease Clinical Trial

NCT06220084 | Active Not Recruiting

• 2 other identifiers: 92282/10.10.2023688/07.09.2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Dance for Parkinson's Disease® (DfPD®) is a specially designed dance program for individuals with PD. This study assesses the efficacy, safety and feasibility of a culturally adapted DfPD® program offered both live and online in Greek PD patients. A total of 40 early-to-mid-stage PD Greek patients have been enrolled to underwent a total of 16 60-min classes twice weekly over 8 weeks both live and online as well as to be part of the non-intervention control group in a 3-arms crossover randomized controlled clinical trial. Assessments will be performed at baseline and at the end of each study period and will include quality of life, fatigue, depressive symptoms, stress, anxiety, sarcopenia, frailty, balance, cognitive functions, movement and non-movement PD symptoms, and Body Mass Index (BMI). Safety and feasibility of each of the dance interventions (live DfPD® vs remote DfPD®) will be assessed.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Dance; Dance for Parkinson's; Quality of Life; Depression; Fatigue; Cognitive Functions; Stress; Anxiety; Frailty; Sarcopenia; Body Mass Index; Balance; Music Preferences

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

Secondary Outcomes (13)

• Change in total score of Parkinson Fatigue Scale-16 (PFS-16)

  Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

• Change in total score of Modified Fatigue Impact Scale (MFIS)

  Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

• Change in total score of Montreal Cognitive Assessment (MoCA)

  Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

• Change in total score of Berg Balance Scale (BBS)

  Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

• Change in Depression Score of Depression, Anxiety and Stress Scale 21 (DASS-21)

  Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

Other Outcomes (4)

• Occurence of Adverse Events and Emergent Adverse Events

  During the interventional periods (live DfPD® and remote DfPD®) for each participant.

• Adherence and Attrition Assessment

  During the intervention (week 2-45)

• Assessment of Patient's Satisfaction

  End of the program (week 45)

Study Arms (3)

Live DfPD®

EXPERIMENTAL

Eight weeks intervention of two 60min live dance classes per week plus their usual care

Behavioral: Dance for PD®

Remote DfPD®

EXPERIMENTAL

Eight weeks intervention of two 60min online-via zoom platform dance classes per week plus their usual care

Behavioral: Dance for PD®

Control

NO INTERVENTION

Non-interventional group in which participants receive their usual care only

Interventions

Dance for PD® BEHAVIORAL

The intervention consists of 16 60-min adapted to Greek culture DfPD® classes, which will be performed twice weekly for 8 weeks and instructed by a single researcher, who has the approval to use it for research reasons. The intervention will be delivered both live and online in separate periods for each participant.

Also known as: Dance for Parkinson's®, DfPD®

Live DfPD®; Remote DfPD®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• 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
• Smart device (either smart phone or tablet/laptop/computer) access for the dance intervention which will be conducted remotely

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
• Any electronic internal medical device or implant, such as a pacemaker or a deep brain stimulation, due to contraindication in the use of bio-electrical impedance analysis
• No access of the participant or patient's carer to any smart device (either smart phone or tablet/laptop/computer)

Sponsors & Collaborators

• University of West Attica: lead
• World in Harmony/Mundo en Armonia: collaborator

Study Sites (1)

Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

Athens, Attica, 12243, Greece

Location

Related Publications (1)

• Elpidoforou M, Grimani I, Papadopoulou M, Papagiannakis N, Bougea A, Simitsi AM, Sfikas E, Alexandratou I, Alefanti I, Antonelou R, Koros C, Mavroyianni I, Chrysovitsanou C, Stefanis L, Bakalidou D. An In-Person and Online Intervention for Parkinson Disease (UPGRADE-PD): Protocol for a Patient-Centered and Culturally Tailored 3-Arm Crossover Trial. JMIR Res Protoc. 2025 May 2;14:e65490. doi: 10.2196/65490.

  PMID: 40314994 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Depression; Fatigue; Anxiety Disorders; Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Groups: live DfPD® vs remote DfPD® vs Control. The experimental period will be of 10 months, including 3 periods of two months intervention for each group (live DfPD® vs remote DfPD®) versus control group (non-intervention group) and 2 washout periods of two months between.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 23, 2024
• Study Start: May 2, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 31, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)